Patient-reported toxicity after colorectal cancer (CRC) treatment.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 484-484
Author(s):  
C. E. Hill-Kayser ◽  
C. Vachani ◽  
M. K. Hampshire ◽  
G. A. Di Lullo ◽  
J. M. Metz
Keyword(s):  
Colorectal Cancer ◽  
Sexual Function ◽  
Cognitive Decline ◽  
Late Effects ◽  
Multimodality Therapy ◽  
Fistula Formation ◽  
Convenience Sample ◽  
Patient Reported ◽  
Gi Toxicity ◽  
The Impact

484 Background: Colorectal cancer patients may be at risk for myriad late effects after multimodality therapy, the impact of which may difficult to evaluate using conventional methods. This Internet-based study evaluates patient perceptions of toxicity after treatment for CRC. Methods: Patient-reported data was gathered via a convenience sample frame from CRC survivors voluntarily utilizing a publically available, free, Internet-based tool for creation of survivorship care plans. Available at www.livestrongcareplan.com and through the OncoLink website, the tool allows survivors to enter data regarding diagnosis, demographics, and treatments, and provides customized guidelines for future care. During use of the tool, CRC survivors are queried regarding late effects associated with specific treatments, and asked to answer “yes,” “no,” or “I don't know.” They are also asked to score GI toxicity using WHO criteria. All data have been maintained with IRB approval. Results: 148 CRC survivors answered queries regarding late effects; 64% were female and 82% Caucasian. Median diagnosis age was 50 (24-76) and median current age 54 (24-77). Most reported having had multimodality therapy - 97% surgery, 89% chemotherapy, and 37% radiation. When queried regarding GI toxicity, 51% reported chronic changes in bowel patterns, 34% chronic diarrhea, 12% bowel obstruction, 18% hernia development, 8% radiation colitis, and 2% fistula formation. Of 18 survivors who graded GI toxicity, 27% reported 4-6 stools per day, and 22% > 6 stools per day or incontinence. When queried regarding sexual function, 31% of men reported worse erectile function than pre-treatment, and 39% of women reported sexual changes such as vaginal dryness. Perceived cognitive decline since diagnosis of cancer was reported by 57%. Conclusions: Survivors using this tool anonymously and voluntarily report significant GI toxicity after cancer treatment. Approximately 1/3 of male and female survivors report impact on sexual function, and more than 50% report perceived cognitive decline. This tool offers a unique way for survivors to report their experiences; the data reported here may be of significant impact in future study of quality of life, as well as patient counseling and survivor care. No significant financial relationships to disclose.

Patient-reported toxicities and comorbidities after treatment for cancers of the upper gastrointestinal tract.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 148-148
Author(s):  
James M. Metz ◽  
Margaret K. Hampshire ◽  
Carolyn Vachani ◽  
Gloria A. Di Lullo ◽  
Christine E. Hill-Kayser
Keyword(s):  
Cancer Survivors ◽  
Late Effects ◽  
Health Problems ◽  
Multimodality Therapy ◽  
Patient Counseling ◽  
Cognitive Changes ◽  
Convenience Sample ◽  
Care Plans ◽  
Patient Reported ◽  
The Impact

148 Background: Patients may be at risk for significant late effects after multimodality therapy for gastric and esophageal (GE) cancers, the impact of which may be difficult to evaluate using conventional methods. This Internet-based study evaluates patient perceptions of toxicity after treatment for GE cancer. Methods: Patient-reported data was gathered via a convenience sample frame from GE cancer survivors voluntarily utilizing a publically available, free, Internet-based tool for creation of survivorship care plans. Available at www.livestrongcareplan.com and through the OncoLink website, the tool allows survivors to enter data regarding diagnosis, demographics, and treatments, and provides customized guidelines for future care. During use of the tool, GE cancer survivors are queried regarding late effects associated with specific treatments. All data have been maintained with IRB approval. Results: Sixty-six GE cancer survivors answered queries regarding late effects; 62% were female and 93% Caucasian. Median diagnosis age was 55 yrs (19–74 yrs), median current age 59 yrs (19–77 yrs), and average time since diagnosis 3.8 yrs. Most reported having had multimodality therapy—88% surgery, 80% chemotherapy, and 48% radiation. When queried regarding persistent health problems after cancer treatment, 35% reported cardiovascular disease (21% hypertension, 13% hyperlipidemia, 3% angina), 28% sexual dysfunction, 36% tinnitus, 24% peripheral neuropathy, 42% cognitive changes, 100% difficulty swallowing, 60% dry mouth or taste changes, 40% dental changes, and 14% chronic lung disease. Conclusions: Survivors using this tool anonymously and voluntarily report significant health problems after treatment for GE cancers. The data reported here may be of significant impact in future study of quality of life, as well as patient counseling and survivor care.

Updated patient reported outcomes and survivorship care plan use by survivors of colorectal cancer (CRC).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 527-527
Author(s):  
James M. Metz ◽  
Margaret K. Hampshire ◽  
Carolyn Vachani ◽  
Gloria A. Di Lullo ◽  
Christine Hill-Kayser
Keyword(s):  
Colorectal Cancer ◽  
Sexual Function ◽  
Late Effects ◽  
Patient Reported Outcomes ◽  
Care Plan ◽  
Survivorship Care Plans ◽  
Survivorship Care ◽  
Care Plans ◽  
Patient Reported ◽  
Gi Toxicity

527 Background: Colorectal cancer patients may be at risk for late effects after treatment, the impact of which may difficult to evaluate using conventional methods. Here, we described patient reported outcomes after CRC, as well as use of survivorship care plans. Methods: Patient-reported data were gathered via a convenience sample frame from CRC survivors voluntarily utilizing a publically available, free, Internet-based tool for creation of survivorship care plans. Available at www.livestrongcareplan.com and through the OncoLinkwebsite, the tool allows survivors to enter data regarding diagnosis, demographics, and treatments, and provides customized guidelines for future care. During use of the tool, CRC survivors are queried regarding late effects associated with specific treatments, and asked to answer “yes,” “no,” or “I don’t know.” They are also asked to score GI toxicity using WHO criteria. All data have been maintained with IRB approval. Results: 657 CRC survivors utilized the care plan and answered queries regarding late effects; 64% were female and 82% Caucasian. Median diagnosis age was 50 (24 – 76) and median current age 54 (24 – 77). Many reported having had multimodality therapy - 97% surgery, 89% chemotherapy, and 37% radiation. Overall, 63% reported chronic changes in bowel patterns, 38% chronic diarrhea, 9% bowel obstruction, 18% hernia development, 8% radiation colitis, and 2% fistula formation. Of 249 survivors who graded GI toxicity, 23% reported 4-6 stools per day, and 18% > 6 stools per day or incontinence. When queried regarding sexual function, 35% of men reported worse erectile function than pre-treatment, and 42% of women reported sexual changes such as vaginal dryness. A follow-up survey was completed by 31 (5%) of users, who reported that care plans improved knowledge about late effects (90%) and potential related treatments and tests (83%). Conclusions: Survivors using this tool report significant toxicity after cancer treatment, mainly related to GI and sexual function. Survivors appear to gain knowledge from survivorship care plans. The data reported here may be of significant impact in future study of quality of life, as well as patient counseling and survivor care.

Survivorship care patterns and late effects after cancers of the pancreas and biliary tract.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 296-296
Author(s):  
Christine E. Hill-Kayser ◽  
Carolyn Vachani ◽  
Margaret K. Hampshire ◽  
Gloria A. Di Lullo ◽  
James M. Metz
Keyword(s):  
Side Effects ◽  
Late Effects ◽  
Multimodality Treatment ◽  
Multimodality Therapy ◽  
Entire Group ◽  
Survivorship Care ◽  
Convenience Sample ◽  
Care Plans ◽  
Patient Reported ◽  
Care Patterns

296 Background: Pancreas and biliary (PBT) cancers are generally associated with poor prognosis, despite aggressive, multimodality therapy. The population of cancer survivors after these diagnoses may be largely ignored, despite risk of late effects. This Internet-based study seeks to evaluate patient-reported toxicities and survivorship care patterns after treatment of PBT cancers. Methods: Patient-reported data were gathered via convenience sample from PBT survivors voluntarily utilizing a publically available Internet-based tool for creation of survivorship care plans. Available at www.livestrongcareplan.com and the OncoLink website, the tool asks survivors to enter data regarding diagnosis, demographics, and treatments, and provides customized guidelines for future care. During use of the tool, PBT survivors are queried regarding late effects associated with specific treatments. Results: 89 PBT survivors utilized the tool from 2010-2012, 66% with pancreas cancer, 20% biliary, and 13% liver. Of the entire group, 59% were female and 81% Caucasian. Median diagnosis age was 59 and median current age 61. Average time since diagnosis was 2 years (range <1-8). Most reported having had multimodality therapy - 71% surgery, 78% chemotherapy, and 46% radiation – although only 30% report continued care from an oncologist and 8% having received previous survivorship information. Of 17 patients queried, 3 had metastatic disease and 3 had recurrent disease. When the entire group was queried regarding possible side effects of treatment, 44% report persistent neuropathy, 24% chronic diarrhea, 21% bowel stricture or obstruction, and 15% chronic skin changes in the radiation portal. Conclusions: Although the prognosis after PBT cancers remains relatively poor, a small population of long-term survivors exists. Survivors using this tool have generally not received survivorship information and most are no longer followed by an oncologist despite having received multimodality treatment. Neuropathy and gastrointestinal side effects appear to be the most bothersome to this group. This tool represents a potential way to provide information to underrepresented survivorship groups such as PBT survivors in the future.

Patient-reported toxicity after treatment for prostate cancer (PC).

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 221-221 ◽  
Author(s):  
Christine E. Hill-Kayser ◽  
Carolyn Vachani ◽  
Margaret K. Hampshire ◽  
Gloria A DiLullo ◽  
James M. Metz
Keyword(s):  
Urinary Incontinence ◽  
Late Effects ◽  
Care Plan ◽  
Healthcare Team ◽  
Patient Counseling ◽  
Convenience Sample ◽  
Care Plans ◽  
Sexual Symptoms ◽  
Patient Reported ◽  
The Impact

221 Background: PC patients may be at risk for significant late effects after treatment, the impact of which may difficult to evaluate in the clinical setting. This Internet based study evaluates patient perceptions of toxicity after treatment for PC. Methods: Patient-reported data was gathered via a convenience sample frame from PC survivors voluntarily utilizing a publically available, free, Internet-based tool for creation of survivorship care plans. Available at www.livestrongcareplan.com, the tool allows survivors to enter data regarding diagnosis, demographics, and treatments, and provides customized guidelines for future care. During use of the tool, PC survivors are queried regarding late effects associated with specific treatments, and asked to answer “yes,” “no,” or “I don’t know.” They are also asked to score urinary and sexual symptoms using adapted scales. Results: Of 4378 survivors using this tool from 4/10-7/11, 203 (5%) had a diagnosis of PC. Median diagnosis age was 59 and median current age 63. 47% reported having undergone radical prostatectomy (RP) and 53% radiation (RT). RT was delivered via x-ray (80%), brachytherapy (15%), protons (3%), and combinations (3%). Hormonal treatment was delivered to 50%. Erectile dysfunction was reported by 65% of PC survivors using this tool, 80% of those having undergone RP, and 52% of those RT. Of men reporting ED, 97% reported that they could have an erection prior to PC treatment. Survivors treated with RP most commonly reported urinary incontinence (42%) and dry ejaculation (27%). Survivors treated with RT reported urinary incontinence (14%) and chronic diarrhea (10%). Most (75%) survivors reported they would share the care plan with their healthcare team; of 25% who reported that they would not, the most common reason was “I did not think they would care.” Conclusions: Survivors using this tool anonymously and voluntarily report significant toxicity after PC treatment, including ED and urinary incontinence. Not all survivors appear comfortable discussing these issues with healthcare providers. This tool offers a unique way for survivors to report their experiences; the data reported here may be of significant impact in future study of quality of life, patient counseling and survivor care.

Patient-reported outcomes after treatment for cancers of the pancreas and biliary tract.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 375-375
Author(s):  
James M. Metz ◽  
Carolyn Vachani ◽  
Margaret K. Hampshire ◽  
Christine E. Hill-Kayser
Keyword(s):  
Side Effects ◽  
Late Effects ◽  
Patient Reported Outcomes ◽  
Multimodality Treatment ◽  
Multimodality Therapy ◽  
Entire Group ◽  
Survivorship Care ◽  
Convenience Sample ◽  
Care Plans ◽  
Patient Reported

375 Background: Pancreas and biliary (PBT) cancers are generally associated with poor overall prognosis, despite aggressive, multimodality therapy. The population of cancer survivors after these diagnoses may be largely ignored, despite risk of late effects. This Internet-based study seeks to evaluate patient-reported outcomes and survivorship care patterns after treatment of PBT cancers. Methods: Patient-reported data were gathered via a convenience sample frame from PBT survivors voluntarily utilizing a publically available Internet-based tool for creation of survivorship care plans. Available through the OncoLinkwebsite, the tool asks survivors to enter data regarding diagnosis, demographics, and treatments, and provides customized guidelines for future care. During use of the tool, PBT survivors are queried regarding late effects associated with specific treatments. Results: 134 PBT survivors utilized the tool from 2010-2014, 67% with pancreas cancer, 20% biliary, and 12% liver. Of the entire group, 59% were female and 81% Caucasian. Median diagnosis age was 59 and median current age 61. Average time since diagnosis was 2 years (range <1-8). Most reported having had multimodality therapy - 71% surgery, 78% chemotherapy, and 46% radiation. Most patients (70%) reported not receiving continued care from an oncologist, and >90% had never received previous survivorship information. Of 35 patients queried, 6 had metastatic disease and 7 had recurrent disease. When the entire group was queried regarding possible side effects of treatment, 44% reported persistent neuropathy, 24% chronic diarrhea, 21% bowel stricture or obstruction, and 15% chronic skin changes in the radiation portal. Conclusions: Although the prognosis after PBT cancers remains relatively poor, a population of long-term survivors exists. Survivors using this tool have generally not received survivorship information and most are no longer followed by an oncologist despite having received multimodality treatment. Neuropathy and gastrointestinal side effects appear to be the most bothersome to this group. This tool represents a potential way to provide information to underrepresented survivorship groups such as PBT survivors in the future.

How well do we communicate with patients concerning adjuvant systemic therapy? A survey of 150 colorectal cancer survivors

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4020-4020 ◽  
Author(s):  
N. Love ◽  
C. Bylund ◽  
N. J. Meropol ◽  
J. L. Marshall ◽  
S. A. Curley ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Side Effects ◽  
Recurrence Risk ◽  
Cold Intolerance ◽  
Treatment Side Effects ◽  
Treatment Benefits ◽  
Trade Offs ◽  
Medical Oncologists ◽  
Gi Toxicity ◽  
The Impact

4020 Background: Adjuvant chemotherapy (AC) presents a substantial patient education challenge to medical oncologists (MOs). Findings from our 2005 pilot survey suggest that a significant fraction of colorectal cancer (CRC) survivors are willing to undergo AC for modest treatment benefits, but their understanding of risks and benefits may be suboptimal. This project attempted to validate these findings by surveying patients with CRC (Pts) who previously received AC. Methods: 150 Pts who received AC for CRC in the last 5 years were recruited to listen to an audio program on AC featuring interviews with clinical investigators (CIs) and Pts who received AC. Based on this input, Pts were asked whether they would undergo the same AC again for varying absolute treatment benefits. A corresponding survey asked 24 CRC CIs and 150 MOs to predict how patients would respond. The survey also queried Pts about their expectations of and experiences with AC side effects. Results: About 1/3 of Pts would be treated again with AC for a 1% absolute reduction in recurrence risk (ARRR), and about 2/3 believed a 5% ARRR would justify treatment. There were no statistically significant differences between responses of males and females or between Pts receiving oxaliplatin (OX) and those receiving other regimens. ( Table 1 ) The corresponding estimates of CIs and MOs were lower. Additionally, AC side effects were different than expected: 57% and 66% of Pts experienced less GI toxicity and alopecia, respectively, while 38% and 46% of Pts receiving OX experienced greater cold intolerance and numbness. Conclusions: Many potential obstacles exist in communicating with Pts about AC including heterogeneity in Pts’ attitudes towards risk/benefit trade-offs and preconceptions about treatment side effects. The next step in this initiative will be to examine these issues prospectively by evaluating the impact of an audio/web education supplement on the decision-making process. [Table: see text] No significant financial relationships to disclose.

The Impact of Socioeconomic Status on Perceived Barriers to Colorectal Cancer Testing

2008 ◽  
Vol 23 (2) ◽  
pp. 97-100 ◽  
Author(s):  
Aimee S. James ◽  
Sandra Hall ◽  
K. Allen Greiner ◽  
Dan Buckles ◽  
Wendi K. Born ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Socioeconomic Status ◽  
Low Income ◽  
Fecal Occult Blood ◽  
Low Ses ◽  
National Guidelines ◽  
Convenience Sample ◽  
Crc Screening ◽  
Screening Barriers ◽  
The Impact

Purpose. Colorectal cancer (CRC) screening is effective, but only one-half of age-eligible adults adhere to national guidelines. Lower socioeconomic status (SES) groups are less likely to be screened. Methods. Baseline data from a prospective study were used to examine the associations among CRC screening screening barriers, and SES. A convenience sample of adults (N = 291) aged 40 years and older was recruited from a federally qualified health center. Questionnaires were administered orally and included demographics, health, health behavior, and screening barriers. Results. In logistic regression, having health insurance was associated with greater odds of screening. Bivariate analyses detected few differences in fecal occult blood test (FOBT) barriers, but several endoscopy barriers were more common among the lowest SES groups. For example, fear of injury from endoscopy was more likely among low-income and uninsured participants. Discussion. The impact of SES on cancer screening is complex, but low-SES participants more often reported certain barriers than their higher-SES counterparts. This was more evident for endoscopy than for FOBT. Programs targeted at low-SES patients may need to focus on barriers that are not fully addressed in traditional promotion efforts.

Toxicity in a multimodality approach of radical prostatectomy with radiation and hormonal therapy.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 107-107
Author(s):  
Stacy Loeb ◽  
Meike Adam ◽  
Pierre Tennstedt ◽  
Wolfgang Huber ◽  
Juergen Bernard ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radical Prostatectomy ◽  
Sexual Function ◽  
Hormonal Therapy ◽  
Urinary Continence ◽  
Urinary Function ◽  
Bootstrap Analysis ◽  
Patient Reported ◽  
The Impact

107 Background: While the optimal use and timing of secondary therapy after radical prostatectomy remain controversial, there are limited data on the patient-reported outcomes following multimodality therapy. Our objective was to assess the impact of additional radiation and/or hormonal therapy on long-term urinary continence, quality of life and potency after radical prostatectomy. Methods: Among 13150 men treated by radical prostatectomy (RP) from 1992-2013, 905 underwent secondary radiation therapy (RP+RT), 407 received androgen deprivation therapy (RP+ADT) and 688 a combination of RT and ADT (RP+RT+ADT). Urinary function, sexual function and quality of life were evaluated annually using self-administrated validated questionnaires. Urinary function was assessed by the use of the number of pads in 24h (analyzed as 0 pads, safety only, 1-2, or ≥ 3 pads). Potency was defined as ≥ 3 points out of 5 on the question whether erections were hard enough for penetration. Quality of life was assessed using a score from 0-100%.The distribution of urinary function, sexual function and quality of life were plotted as a function of time after bootstrap analysis (n = 1000) of a propensity score matched cohort. Results: Urinary function. The distribution of 0 pads and 1 safety pad between patients with a) RP and RP+RT was 72.3% vs. 67.9% and 16.7% vs. 18.6%; b) between RP and RP+HT was 64.5% vs. 55.5% and 16.1% vs. 21.9%; c) between RP and RP+RT+ADT was 67.4% vs. 54.8% and 17.7% vs. 21.8% and d) between RP+RT and RP+RT+ADT was 64.5% vs. 55.5% and 16.1% vs. 21.9%. Potency. The distribution of potency between patients with a) RP and RP+RT was 62.9% vs. 40.0%; b) between RP and RP+HT was 59.1% vs. 29.3%; c) between RP and RP+RT+ADT was 57.4% vs. 24.0% and d) between RP+RT and RP+RT+ADT was 44.2% vs. 32.1%. Quality of life. The distribution of a score of 83.3%-100% between patients with a) RP and RP+RT was 67.9% vs. 57.4%; b) between RP and RP+HT was 57.8% vs. 41.7%; c) between RP and RP+RT+ADT was 59.3% vs. 48.2% and d) between RP+RT and RP+RT+ADT was 60.0% vs. 41.2%. Conclusions: Secondary therapy after radical prostatectomy has a negative influence on urinary function, potency and quality of life.

scholarly journals Patient-Reported Quality of Supportive Care Among Patients With Colorectal Cancer in the Veterans Affairs Health Care System

2014 ◽  
Vol 32 (8) ◽  
pp. 809-815 ◽  
Author(s):  
Michelle van Ryn ◽  
Sean M. Phelan ◽  
Neeraj K. Arora ◽  
David A. Haggstrom ◽  
George L. Jackson ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Supportive Care ◽  
Cancer Care ◽  
Quality Measurement ◽  
Veterans Affairs ◽  
Health Administration ◽  
Patient Centered ◽  
Patient Reported ◽  
The Impact

Purpose High-quality supportive care is an essential component of comprehensive cancer care. We implemented a patient-centered quality of cancer care survey to examine and identify predictors of quality of supportive care for bowel problems, pain, fatigue, depression, and other symptoms among 1,109 patients with colorectal cancer. Patients and Methods Patients with new diagnosis of colorectal cancer at any Veterans Health Administration medical center nationwide in 2008 were ascertained through the Veterans Affairs Central Cancer Registry and sent questionnaires assessing a variety of aspects of patient-centered cancer care. We received questionnaires from 63% of eligible patients (N = 1,109). Descriptive analyses characterizing patient experiences with supportive care and binary logistic regression models were used to examine predictors of receipt of help wanted for each of the five symptom categories. Results There were significant gaps in patient-centered quality of supportive care, beginning with symptom assessment. In multivariable modeling, the impact of clinical factors and patient race on odds of receiving wanted help varied by symptom. Coordination of care quality predicted receipt of wanted help for all symptoms, independent of patient demographic or clinical characteristics. Conclusion This study revealed substantial gaps in patient-centered quality of care, difficult to characterize through quality measurement relying on medical record review alone. It established the feasibility of collecting patient-reported quality measures. Improving quality measurement of supportive care and implementing patient-reported outcomes in quality-measurement systems are high priorities for improving the processes and outcomes of care for patients with cancer.

scholarly journals BESPOKE study protocol: a multicentre, prospective observational study to evaluate the impact of circulating tumour DNA guided therapy on patients with colorectal cancer

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047831
Author(s):  
Pashtoon Murtaza Kasi ◽  
Sarah Sawyer ◽  
Jessica Guilford ◽  
Michelle Munro ◽  
Sascha Ellers ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Study Protocol ◽  
Clinical Utility ◽  
Stage I ◽  
Study Results ◽  
Patient Reported ◽  
Circulating Tumour Dna ◽  
The Impact ◽  
Guided Therapy

IntroductionColorectal cancer (CRC) is a highly prevalent disease, wherein, ~30%–40% of patients with CRC relapse postresection. In some patients with CRC, adjuvant chemotherapy can help delay recurrence or be curative. However, current biomarkers show limited clinical utility in determining if/when chemotherapy should be administered, to provide benefit. Circulating tumour DNA (ctDNA) can measure molecular residual disease (MRD) and relapse with high specificity and sensitivity. This study protocol investigates the clinical utility of ctDNA for optimal use of adjuvant chemotherapy in patients with surgically resected CRC and to detect early disease progression in the surveillance setting.Methods and analysisThis is a multicentre prospective, observational cohort study. A total of 2000 stage I–IV patients will be enrolled in up to 200 US sites, and patients will be followed for up to 2 years with serial ctDNA analysis, timed with the standard-of-care visits. The primary endpoints are to observe the impact of bespoke ctDNA testing on adjuvant treatment decisions and to measure CRC recurrence rates while asymptomatic and without imaging correlate. The secondary endpoints are MRD clearance rate (MRD+ to MRD−) during or after adjuvant chemotherapy, percentage of patients that undergo surgery for oligometastatic recurrence, survival of MRD-negative patients treated with adjuvant chemotherapy versus no adjuvant chemotherapy (active surveillance), overall survival, examine the number of stage I CRC that have recurrent disease detected postsurgery, and patient-reported outcomes.Ethics and disseminationThis study has received ethical approval from the Advarra Institutional Review Board (IRB) protocol: Natera—20-041-NCP/3766.01, BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer (BESPOKE CRC) (Pro00041473) on 10 June 2021. Data protection and privacy regulations will be strictly observed in the capturing, forwarding, processing and storing of patients’ data. Publication of any study results will be approved by Natera in accordance with the site-specific contract.Trial registration numberNCT04264702.

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