scholarly journals Liquid biopsies for colorectal cancer: a narrative review of ongoing clinical trials and the current use of this technology at a comprehensive cancer center

2021 ◽  
Vol 0 (0) ◽  
pp. 0-0
Author(s):  
Sacha P. Broccard ◽  
Ali Abbaszadeh Kasbi ◽  
Sanjay P. Bagaria ◽  
Jeremy Jones ◽  
Mira Shoudry ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Narrative Review ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Liquid Biopsies

scholarly journals Definition and Coordination of Roles and Responsibilities Among Cancer Center Clinic and Research Personnel

2020 ◽  
Vol 16 (1) ◽  
pp. e64-e74
Author(s):  
Simon J. Craddock Lee ◽  
Torsten Reimer ◽  
Sandra Garcia ◽  
Erin L. Williams ◽  
Mary West ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Physician Attitudes ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Research Staff ◽  
Research Personnel ◽  
Delivery Of Care ◽  
Roles And Responsibilities ◽  
Clinic Staff ◽  
Staff Members

PURPOSE: Effective enrollment and treatment of patients in cancer clinical trials require definition and coordination of roles and responsibilities among clinic and research personnel. MATERIALS AND METHODS: We developed a survey that incorporated modified components of the Survey of Physician Attitudes Regarding the Care of Cancer Survivors. Surveys were administered to clinic nursing staff and research personnel at a National Cancer Institute–designated comprehensive cancer center. Results were analyzed using χ2-tests, t tests, and analyses of variance. RESULTS: Surveys were completed by 105 staff members (n = 50 research staff, n = 55 clinic staff; 61% response rate). Research staff were more likely to feel that they had the skills to answer questions, convey information, and provide education for patients on trials (all P < .05). Both clinic and research staff reported receipt of communication about responsibilities in fewer than 30% of cases, although research staff reported provision of such information in more than 60% of cases. Among 20 tasks related to care of patients in trials, no single preferred model of responsibility assignment was selected by the majority of clinic staff for nine tasks (45%) or by research staff for three tasks (15%). Uncertainty about which team coordinates care was reported by three times as many clinic staff as research staff ( P = .01). There was also substantial variation in the preferred model for delivery of care to patients in trials ( P < .05). CONCLUSION: Knowledge, attitudes, and perception of care and responsibilities for patients on clinical trials differ between and among clinic and research personnel. Additional research about how these findings affect efficiency and quality of care on clinical trials is needed.

scholarly journals Cancer Patient-Reported Preferences and Knowledge for Liquid Biopsies and Blood Biomarkers at a Comprehensive Cancer Center

2020 ◽  
Vol Volume 12 ◽  
pp. 1163-1173
Author(s):  
Min Joon Lee ◽  
Katrina Hueniken ◽  
Nathan Kuehne ◽  
Lin Lu ◽  
Shirley Xue Jiang ◽  
...  
Keyword(s):  
Cancer Patient ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Blood Biomarkers ◽  
Liquid Biopsies ◽  
Patient Reported

Metastatic colorectal cancer (mCRC) patterns of care: Implications for clinical trial design

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4079-4079 ◽  
Author(s):  
C. S. Denlinger ◽  
M. A. Collins ◽  
Y. Wong ◽  
S. Litwin ◽  
N. J. Meropol
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Trial Design ◽  
Clinical Trial Design ◽  
New Drugs ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Treatment Change ◽  
Therapy Regimen

4079 Background: New approaches have expanded options for patients (pts) with mCRC. To characterize current practice paradigms that might bear on clinical trial design, we analyzed decision-making and treatment patterns in pts treated at a Comprehensive Cancer Center since the introduction of cetuximab (CET), and bevacizumab (BV). Methods: A retrospective review of all pts diagnosed with mCRC between 3/1/04 and 8/28/06 treated at Fox Chase Cancer Center. Results: 160 pts were treated, with 157 pts receiving at least one therapy regimen by 10 attending oncologists. There were 350 changes in therapy with 246 (70%) including continuation of at least one prior drug (92 BV, 111 fluoropyrimidines, 43 other). The most common reasons for treatment change were toxicity (33%), progressive disease (PD) (29%), treatment breaks (15%), and metastasectomy (11%) ( Table ). PD was a more common cause for treatment discontinuation in later phases of treatment (18% initial regimen vs. 36% subsequent regimens, p=0.0002). 24% of pts treated with oxaliplatin (OX) discontinued due to neuropathy. Hypersensitivity caused discontinuation in 5% of pts with OX and 7% of pts with CET. Resection of metastases was undertaken in 38% of pts. 43% of these pts received neoadjuvant therapy, and 56% received adjuvant therapy. 30% of pts have died, 29% remain on active treatment, 28% are on a treatment break, 3% are on hospice, and 11% are lost to follow-up. Conclusions: PD is no longer the primary reason for change of therapy in pts with mCRC. Metastasectomy is common and OX neuropathy is often treatment-limiting. These findings have important implications for endpoint selection and design of clinical trials in mCRC. Future clinical trials in mCRC must recognize treatment complexities and capture key components of decision-making that may result in prolonged survival. Furthermore, treatment breaks represent a potential window for the evaluation of new drugs. [Table: see text] No significant financial relationships to disclose.

Health care worker attitudes about clinical trials at a comprehensive cancer center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20633-e20633
Author(s):  
Erica Leigh Campagnaro ◽  
Seunghee Margevicius ◽  
Barbara J. Daly ◽  
Jennifer Rachel Eads ◽  
Tyler G. Kinzy ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Self Efficacy ◽  
Small Sample Size ◽  
Educational Interventions ◽  
Small Sample ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Normative Beliefs ◽  
The Impact

e20633 Background: Cancer patient (pt) participation in clinical trials (CT) is low. Little is known about the beliefs and attitudes of health care workers (HCW) and how they impact intention to discuss CT with pts. The overall goal of this project was to develop a conceptual model to guide future interventions to enhance communication about CT between HCW and cancer pts. Methods: Two email surveys of non-physician HCW at an NCI-designated comprehensive cancer center were conducted. The first was sent to a random sample of 150 HCW. The second was sent to 80 who completed the first survey. Based on our prior work (Eads et al. ASCO 2011) and Ajzen’s Theory of Planned Behavior, domains of the first included CT knowledge (19 items, agree/disagree) and attitudes (27 items, 5-point Likert); the second included normative beliefs about institutional attitudes toward CT (6 items, 5-point Likert), self-efficacy about engaging in discussion about CT (14 items, 5-point Likert), and intention to discuss CT with pts (4 items, 7-point Likert). Results: 41 HCW completed both anonymous surveys; 27 could be matched by demographics. Median age of matched respondents was 44.3 yrs (range 24-63), 26 female, 22 caucasian, 9 nurses. Overall, CT knowledge was high (median 17/19 items correct). There were strong associations between attitudes and self-efficacy (Spearman r=-0.425, p=0.03), as well as perceived normative beliefs and self-efficacy (r=0.651, p=0.0002). These associations were strong amongst nurses (r=-0.818, p=0.007 and r=0.656, p=0.05, respectively), with a particularly strong correlation between self-efficacy and intention to discuss clinical trials with pts (r=0.891, p=0.001). Conclusions: In spite of a small sample size, these pilot data strongly support a behavioral framework to understand and address the impact of HCW attitudes and beliefs about CT on discussions of CT with pts. Insofar as HCW (especially nurses) have substantial pt contact, and serve as a resource for pts regarding treatment decisions, educational interventions to address HCW barriers to discussing CT with pts (i.e. attitudes, beliefs, and self-efficacy) could positively impact pt attitudes and improve decision making.

Gender specific profiling in SCN1A polymorphisms and time to recurrence in patients with stage II/III colorectal cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 393-393
Author(s):  
Leonor Benhaim ◽  
Armin Gerger ◽  
Pierre Oliver Bohanes ◽  
David Paez ◽  
Takeru Wakatsuki ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Los Angeles ◽  
Recurrence Rate ◽  
Tumour Progression ◽  
Univariate Analysis ◽  
Stage Ii ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Α Subunit ◽  
Time To Recurrence

393 Background: Voltage-gated Na + channels (VGSCs) are involved in cells signalling and strongly contribute in the process of tumour progression. Two single nucleotide polymorphisms (SNPs) in the SCN1A gene encoding the α-subunit of VGSC recently showed an interesting gender-related association with survival in patients with metastatic colorectal cancer (CRC). The current study was designed to confirm the association between SCN1A and time to recurrence (TTR) in patients with stage II and III CRC and determine the influence of the gender on this association. Methods: The study enrolled patients with histologically confirmed CRC high risk stage II and stage III treated from 1987 to 2007 with adjuvant 5-FU-based chemotherapy at the University of Southern California/Norris Comprehensive Cancer Center (USC/NCCC) or in the Los Angeles County/USC Medical Center (LAC/USCMC). Peripheral blood samples were collected for each patient at the date of diagnosis. Genotypes were determined after DNA extraction and PCR amplification by direct sequencing. Results: A total of 127 males and 107 females were enrolled in this study. Baseline demographic and clinical characteristics according to the gender were similar. In univariate analysis female patients carrying the SCN1A rs3812718 TT genotype showed a significant shortened time to recurrence rate when compared to females with the alternate CT or CC genotype (HR: 2.26 [95%CI: 0.89, 5.70], p=0.039). This association remained significant in multivariate analysis. By contrast, in the male population, the shortened time to recurrence rate was oppositely associated with the CC genotype (HR: 0.49 [95%CI: 0.18, 1.38], p=0.048). For the SCN1A rs229877, in both female and male populations the CT genotype was associated with a trend for a shorter TTR. Conclusions: Our findings confirm that genomic SCN1A rs3812718 polymorphism is associated with TTR in patients with stage II and III CRC, supporting the hypothesis that this association is gender dependent. We furthermore verified the trend of a shorter recurrence rate for patients harboring the CT genotype in SCN1A rs229877 regardless of their gender.

Molecular profiling of TOPO1: A way to evaluate irinotecan treatment in colorectal cancer?

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 546-546
Author(s):  
Julia Marie Cunningham ◽  
Petra Prins ◽  
Brian Conkright ◽  
Simina Boca ◽  
Shruti Rao ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Small Sample Size ◽  
Predictive Marker ◽  
Molecular Profiling ◽  
Small Sample ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Control Group ◽  
Similar Response ◽  
Second Line

546 Background: Front-line chemotherapy for metastatic colorectal cancer (mCRC) consists of a fluoropyrimidine backbone plus either oxaliplatin (FOLFOX or XELOX) or irinotecan (FOLFIRI or XELIRI). Large, prospective trials enrolling chemotherapy-naïve patients (pts) show FOLFOX and FOLFIRI treatment to be equivalent with similar response rates. Methods: Irinotecan inhibits TOPO1, which is now a candidate marker for irinotecan treatment benefit. Thus, we retrospectively analyzed TOPO1 expression level in 49 pts with mCRC who were treated with irinotecan-containing regimens at the Lombardi Comprehensive Cancer Center between 2009 and 2014. Patient characteristics and outcomes were compiled through chart review and the effect of TOPO1 expression on clinical outcomes was assessed. TOPO1 expression in tumor tissue from each pt was analyzed using a commercially available molecular profiling (MP) service (Caris Life Sciences). Results: The median overall survival (OS) for all pts was 33.9 months (mo), defined as the time from metastasis to death or censorship. When grouped by “high” or “low” TOPO1 expression, as defined by Caris at the time of the testing, 29 pts were high-expressers and 20 were low-expressers. High TOPO1 expressers receiving irinotecan (n = 22) had a median OS of 27.2 mo, compared with median 41.5 mo for low-expressers (n = 14) (p = 0.27). Irinotecan is conventionally given as second-line therapy. The median OS of pts receiving second-line irinotecan was 38.2 mo for high-expressers [n = 11] vs. 68.5 mo for low-expressers [n = 5]) (p = 0.32). Conclusions: Our limited data do not support the use of TOPO1 expression levels as a predictive marker for irinotecan therapy in mCRC. However, our conclusions are limited by small sample size, lack of a control group to distinguish prognostic from predictive markers, and timing of TOPO1 measurement, which in many cases was after irinotecan therapy. Physicians currently lack an evidence-based way to choose between potentially efficacious regimens for mCRC. More rigorous studies are needed to assess the benefit of MP in mCRC care. We are currently planning a prospective study with the hope of validating the use of TOPO1 expression as a predictive marker for treatment of this disease.

Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials

2006 ◽  
Vol 24 (28) ◽  
pp. 4545-4552 ◽  
Author(s):  
David M. Dilts ◽  
Alan B. Sandler
Keyword(s):  
Clinical Trials ◽  
The United States ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Community Practice ◽  
Home Office ◽  
Scientific Review ◽  
Oncology Research ◽  
Oncology Clinical Trials ◽  
The Impact

Purpose To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites. Methods VICC, a National Cancer Institute–designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data. Results At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps. Conclusion There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.

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