Clinical impact of medical policy supporting universal germline testing for patients with colorectal cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 10514-10514
Author(s):  
Sarah M. Nielsen ◽  
Joline Dalton ◽  
Kathryn E. Hatchell ◽  
Stacey DaCosta Byfield ◽  
Chad Moretz ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Genetic Testing ◽  
Clinical Information ◽  
The United States ◽  
Clinical Treatment ◽  
Administrative Claims ◽  
Treatment Trials ◽  
Precision Therapy ◽  
Medical Policy ◽  
Germline Testing

10514 Background: Colorectal cancer (CRC) affects approximately 104,000 patients (pts) annually in the United States, up to 45% of which are estimated to be genetic and/or familial. Aligned with clinical guidelines, in 2020, a large U.S. insurer established Medical Policy allowing for and reimbursing germline genetic testing (GGT) for all CRC pts. This study reports overall uptake of GGT in CRC pts under this inclusive policy, actionable findings and treatment implications for pts tested, stratified by self-reported ancestry/ethnicity. Methods: Two independent de-identified datasets were reviewed, including administrative claims data of commercially insured and Medicare Advantage enrollees, aged 18+ with CRC (≥1 claim with ICD10 C18, C19 or C20 in the first position) who were continuously enrolled (CE) in the health plan from 1/2019-10/2020. Evidence of genetic testing based on CPT codes, was examined during 2020. A second de-identified dataset of CRC pts whose GGT was billed to the insurer under the Medical Policy, was also reviewed. Patient demographics, clinical information and GGT results were descriptively analyzed. Results: Of the >18,000,000 CE enrollees, 55,595 were identified as CRC pts, of whom 1,675 (3%) received GGT. From the GGT dataset, 788 pts had test results available for review. 143 (18%) pts had pathogenic/likely pathogenic (P/LP) variants in genes including MSH2, MLH1, PMS2, MSH6, CHEK2, APC, BRCA2, ATM, MUTYH (biallelic). Of pts with P/LP variants, 96 (67%) were potentially eligible for precision therapy and/or clinical treatment trials. Overall, 133 (93%) had P/LP variants in genes with precision therapy, clinical trial and/or published management implications. In a subset of pts (n=674) with ethnicity data; Asian, Black/African-American and Hispanic pts showed lower relative uptake of germline testing than Caucasians (Table). Conclusions: Despite Medical Policy allowing for GGT for all pts with CRC, only 3% of eligible pts received testing. If all CRC pts had been tested, these data suggest up to 6,705 pts with P/LP variants conferring potential eligibility for precision therapy (PD-1/PD-L1 inhibitors) or clinical treatment trials (PARP inhibitors), and an additional 2,602 pts with mutations in genes with published management recommendations, could have been identified, but were missed. Additional research is needed to identify obstacles to systematic implementation of this Medical Policy, the best timing of GGT to prevent CRC and improve access to underrepresented populations. CRC patients with germline genetic testing.[Table: see text]

scholarly journals Identification of 6 Hub Proteins and Protein Risk Signature of Colorectal Cancer

2020 ◽  
Vol 2020 ◽  
pp. 1-17
Author(s):  
Taohua Yue ◽  
Cheng Liu ◽  
Jing Zhu ◽  
Zhihao Huang ◽  
Shihao Guo ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cox Regression ◽  
Kinase Inhibitor ◽  
Pearson Correlation ◽  
Enrichment Analysis ◽  
Clinical Information ◽  
The United States ◽  
Resistance Pathway ◽  
Study Results ◽  
Hub Proteins

Background. Colorectal cancer (CRC) is the second most common cause of cancer death in the United States and the third most common cancer globally. The incidence of CRC tends to be younger, and we urgently need a reliable prognostic assessment strategy. Methods. Protein expression profile and clinical information of 390 CRC patients/samples were downloaded from the TCPA and TCGA database, respectively. The Kaplan-Meier, Cox regression, and Pearson correlation analysis were applied in this study. Results. Based on the TCPA and TCGA database, we screened 6 hub proteins and first constructed protein risk signature, all of which were significantly associated with CRC patients’ overall survival (OS). The risk score was an independent prognostic factor and significantly related with the size of the tumor in situ ( T ). 6 hub proteins were differentially expressed in cancer and normal tissues and in different CRC stages, which were validated at the ONCOMINE database. Next, 40 coexpressed proteins of 6 hub proteins were extracted from the TCPA database. In the protein-protein interaction (PPI) network, HER1, HER2, and CTNNB1 were at the center. Function enrichment analysis illustrated that 46 proteins were mainly involved in the EGFR (HER1) tyrosine kinase inhibitor resistance pathway. Conclusion. Studies indicated that 6 hub proteins might be considered as new targets for CRC therapies, and the protein risk signature can be used to predict the OS of CRC patients.

Trends in obesity among patients registered to SWOG cancer clinical treatment trials.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 126-126
Author(s):  
Riha Vaidya ◽  
Cathee Till ◽  
Heather Greenlee ◽  
Dawn L. Hershman ◽  
Joseph M. Unger
Keyword(s):  
Clinical Trials ◽  
Linear Trend ◽  
The United States ◽  
Clinical Treatment ◽  
Research Network ◽  
Good Representation ◽  
Obesity Prevalence ◽  
Treatment Trials ◽  
Treatment Type ◽  
Prevalence Of Obesity

126 Background: Rising obesity rates have been documented in the United States population since the 1980s. Several studies have shown links between obesity and the incidence of – and the outcomes of – specific cancer types. Few studies have examined the prevalence of obesity among cancer patients at the time of diagnosis or among those who participate in clinical trials. We examined the prevalence of obesity over a 35-year period among patients enrolled in clinical treatment trials conducted by the SWOG Cancer Research Network. Methods: We analyzed body mass index (BMI) at registration among patients enrolled in phase II or III clinical trials conducted by SWOG. Adult patients (age≥18) participating in trials in obesity-related cancers between 1985 and 2020 were included. Obesity was classified as BMI ≥ 30 kg/m2. Multivariable logistic regression was used to examine time trends, adjusting for age, sex, race, and treatment type. Time was defined as year of enrollment and examined in separate models as continuous years and as 5-year intervals. We examined trends among patient subgroups by sex and by treatment type (chemotherapy, immunotherapy, and targeted therapy). Results: 16,374 patients enrolled in SWOG clinical trials conducted between 1985 and 2020 were analyzed. Patients were most commonly enrolled in trials for breast cancer (n = 6,327, 38.6%), colon cancer (n = 2,408, 14.7%), multiple myeloma (n = 2,112, 12.9%), and rectal cancer (n = 1,785, 10.9%). Overall, 32% of patients were obese (n = 5,252). Unadjusted obesity rates among trial participants increased from 18% in 1985-1990 to 42% in 2016-2020, compared to an increase from 23% to 42% among US adults over a similar period. Obesity prevalence rates increased over time for all sex, age, and race subgroups. Overall, there was an increasing linear trend in obesity (OR = 1.36 for each 5-year increase, 95% CI: 1.33-1.39, p < .0001). These trends persisted with adjustments for age, sex, race, and treatment type (OR = 1.35 per 5-year increase, 95% CI: 1.31-1.39, p < .0001). Positive linear trends in obesity prevalence were observed for all subgroups by sex and treatment type. There was no evidence of difference in trends between males and females or between the three treatment types. Conclusions: We observed an increasing trend in obesity among patients participating in clinical trials for obesity-related cancers, mirroring US adult obesity rates. Our findings indicate good representation of obese patients in clinical treatment trials, which has favorable implications for the applicability of trial findings to this group of patients.

Suicidal Behavior and Non-Suicidal Self-Injury in Emergency Departments Underestimated by Administrative Claims Data

Crisis ◽  
2018 ◽  
Vol 39 (5) ◽  
pp. 318-325 ◽  
Author(s):  
Barbara Stanley ◽  
Glenn W. Currier ◽  
Megan Chesin ◽  
Sadia Chaudhury ◽  
Shari Jager-Hyman ◽  
...  
Keyword(s):  
Emergency Departments ◽  
Suicide Attempts ◽  
The United States ◽  
Administrative Claims ◽  
Suicide Attempters ◽  
Self Injury ◽  
Axis I ◽  
Ed Visits ◽  
External Causes ◽  
Severe Psychopathology

Abstract. Background: External causes of injury codes (E-codes) are used in administrative and claims databases for billing and often employed to estimate the number of self-injury visits to emergency departments (EDs). Aims: This study assessed the accuracy of E-codes using standardized, independently administered research assessments at the time of ED visits. Method: We recruited 254 patients at three psychiatric emergency departments in the United States between 2007 and 2011, who completed research assessments after presenting for suicide-related concerns and were classified as suicide attempters (50.4%, n = 128), nonsuicidal self-injurers (11.8%, n = 30), psychiatric controls (29.9%, n = 76), or interrupted suicide attempters (7.8%, n = 20). These classifications were compared with their E-code classifications. Results: Of the participants, 21.7% (55/254) received an E-code. In all, 36.7% of research-classified suicide attempters and 26.7% of research-classified nonsuicidal self-injurers received self-inflicted injury E-codes. Those who did not receive an E-code but should have based on the research assessments had more severe psychopathology, more Axis I diagnoses, more suicide attempts, and greater suicidal ideation. Limitations: The sample came from three large academic medical centers and these findings may not be generalizable to all EDs. Conclusion: The frequency of ED visits for self-inflicted injury is much greater than current figures indicate and should be increased threefold.

scholarly journals National Estimates of Genetic Testing in Women With a History of Breast or Ovarian Cancer

2017 ◽  
Vol 35 (34) ◽  
pp. 3800-3806 ◽  
Author(s):  
Christopher P. Childers ◽  
Kimberly K. Childers ◽  
Melinda Maggard-Gibbons ◽  
James Macinko
Keyword(s):  
Ovarian Cancer ◽  
Genetic Testing ◽  
Unmet Need ◽  
Cancer Control ◽  
The United States ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
Age Of Diagnosis ◽  
History Of ◽  
Interview Survey

Purpose In the United States, 3.8 million women have a history of breast (BC) or ovarian cancer (OC). Up to 15% of cases are attributable to heritable mutations, which, if identified, provide critical knowledge for treatment and preventive care. It is unknown how many patients who are at high risk for these mutations have not been tested and how rates vary by risk criteria. Methods We used pooled cross-sectional data from three Cancer Control Modules (2005, 2010, 2015) of the National Health Interview Survey, a national in-person household interview survey. Eligible patients were adult females with a history of BC and/or OC meeting select 2017 National Comprehensive Cancer Network eligibility criteria on the basis of age of diagnosis and family history. Outcomes included the proportion of individuals reporting a history of discussing genetic testing with a health professional, being advised to undergo genetic testing, or undergoing genetic testing for BC or OC. Results Of 47,218 women, 2.7% had a BC history and 0.4% had an OC history. For BC, 35.6% met one or more select eligibility criteria; of those, 29.0% discussed, 20.2% were advised to undergo, and 15.3% underwent genetic testing. Testing rates for individual eligibility criteria ranged from 6.2% (relative with OC) to 18.2% (diagnosis ≤ 45 years of age). For OC, 15.1% discussed, 13.1% were advised to undergo, and 10.5% underwent testing. Using only four BC eligibility criteria and all patients with OC, an estimated 1.2 to 1.3 million individuals failed to receive testing. Conclusion Fewer than one in five individuals with a history of BC or OC meeting select National Cancer Comprehensive Network criteria have undergone genetic testing. Most have never discussed testing with a health care provider. Large national efforts are warranted to address this unmet need.

scholarly journals Progress in Diagnosing Primary Ciliary Dyskinesia: The North American Perspective

Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1278
Author(s):  
Michael Glenn O’Connor ◽  
Amjad Horani ◽  
Adam J. Shapiro
Keyword(s):  
Genetic Testing ◽  
North America ◽  
North American ◽  
Primary Ciliary Dyskinesia ◽  
Clinical Phenotype ◽  
The United States ◽  
Diagnostic Process ◽  
The North ◽  
Diagnostic Guideline ◽  
Ciliary Dyskinesia

Primary Ciliary Dyskinesia (PCD) is a rare, under-recognized disease that affects respiratory ciliary function, resulting in chronic oto-sino-pulmonary disease. The PCD clinical phenotype overlaps with other common respiratory conditions and no single diagnostic test detects all forms of PCD. In 2018, PCD experts collaborated with the American Thoracic Society (ATS) to create a clinical diagnostic guideline for patients across North America, specifically considering the local resources and limitations for PCD diagnosis in the United States and Canada. Nasal nitric oxide (nNO) testing is recommended for first-line testing in patients ≥5 years old with a compatible clinical phenotype; however, all low nNO values require confirmation with genetic testing or ciliary electron micrograph (EM) analysis. Furthermore, these guidelines recognize that not all North American patients have access to nNO testing and isolated genetic testing is appropriate in cases with strong clinical PCD phenotypes. For unresolved diagnostic cases, referral to a PCD Foundation accredited center is recommended. The purpose of this narrative review is to provide insight on the North American PCD diagnostic process, to enhance the understanding of and adherence to current guidelines, and to promote collaboration with diagnostic pathways used outside of North America.

scholarly journals EPID-07. ACCESS TO GLIOBLASTOMA CLINICAL TRIALS FOR RURAL PATIENTS IN THE UNITED STATES FROM 2010–2020

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii79-ii79
Author(s):  
Kathryn Nevel ◽  
Samuel Capouch ◽  
Lisa Arnold ◽  
Katherine Peters ◽  
Nimish Mohile ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Rural Communities ◽  
The United States ◽  
Interventional Treatment ◽  
Phase Ii Trials ◽  
Treatment Trials ◽  
Rural Sites ◽  
Rural Patients ◽  
Urban Sites

Abstract BACKGROUND Patients in rural communities have less access to optimal cancer care and clinical trials. For GBM, access to experimental therapies, and consideration of a clinical trial is embedded in national guidelines. Still, the availability of clinical trials to rural communities, representing 20% of the US population, has not been described. METHODS We queried ClinicalTrials.gov for glioblastoma interventional treatment trials opened between 1/2010 and 1/2020 in the United States. We created a Structured Query Language database and leveraged Google application programming interfaces (API) Places to find name and street addresses for the sites, and Google’s Geocode API to determine the county location. Counties were classified by US Department of Agriculture Rural-Urban Continuum Codes (RUCC 1–3 = urban and RUCC 4–9 = rural). We used z-ratios for rural-urban statistical comparisons. RESULTS We identified 406 interventional treatment trials for GBM at 1491 unique sites. 8.7% of unique sites were in rural settings. Rural sites opened an average of 1.7 trials/site and urban sites 2.8 trials/site from 1/2010–1/2020. Rural sites offered more phase II trials (63% vs 57%, p= 0.03) and fewer phase I trials (22% vs 28%, p= 0.01) than urban sites. Rural locations were more likely to offer federally-sponsored trials (p&lt; 0.002). There were no investigator-initiated or single-institution trials offered at rural locations, and only 1% of industry trials were offered rurally. DISCUSSION Clinical trials for GBM were rarely open in rural areas, and were more dependent on federal funding. Clinical trials are likely difficult to access for rural patients, and this has important implications for the generalizability of research as well as how we engage the field of neuro-oncology and patient advocacy groups in improving patient access to trials. Increasing the number of clinical trials in rural locations may enable more rural patients to access and enroll in GBM studies.

scholarly journals Evaluation of Blood Stool Test Utilization for Colorectal Cancer Screening in Georgia, USA

Healthcare ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 569
Author(s):  
Benjamin E. Ansa ◽  
Nicollette Lewis ◽  
Zachary Hoffman ◽  
Biplab Datta ◽  
J. Aaron Johnson
Keyword(s):  
Colorectal Cancer ◽  
Insurance Coverage ◽  
The United States ◽  
Sociodemographic Factors ◽  
Behavioral Risk ◽  
Early Screening ◽  
Annual Percent Change ◽  
Crc Screening ◽  
Behavioral Risk Factor Surveillance ◽  
And Control

Colorectal cancer (CRC) is the third most prevalent cancer and the second most common cause of cancer-related deaths in the United States (USA). Early screening has been demonstrated to improve clinical outcomes for CRC. Assessing patterns in CRC screening utilization is important for guiding policy and implementing programs for CRC prevention and control. This study examines the trends and sociodemographic factors associated with blood stool test utilization (BSTU) for CRC screening in Georgia, USA. The Behavioral Risk Factor Surveillance System (BRFSS) data were analyzed for Average Annual Percent Change (AAPC) in BSTU between 1997 and 2014 among adults aged 50+ who have had a blood stool test within the past two years, and logistic regression analysis of the 2016 data was performed to identify the associated sociodemographic factors. In Georgia, an overall decrease was observed in BSTU, from 27.8% in 1997 to 16.1% in 2014 (AAPC = −2.6, p = 0.023). The decrease in BSTU was less pronounced in Georgia than nationally (from 26.1% in 1997 to 12.8% in 2014 (AAPC = −4.5, p < 0.001)). BSTU was significantly associated with black race/ethnicity (Black vs. White (aOR = 1.43, p = 0.015)), older age (≥70 vs. 50–59 (aOR = 1.62, p = 0.006)), having insurance coverage (no vs. yes (aOR = 0.37 p = 0.005)), and lower income (≥USD 50,000 vs. <USD 25,000 (aOR = 0.70 p = 0.050)). These findings reveal a decrease over time in BSTU in Georgia, with existing differences between sociodemographic groups. Understanding these patterns helps in directing tailored programs for promoting CRC screening, especially among disadvantaged populations.

Progressive alteration of DNA methylation of Alu, MGMT, MINT2, and TFPI2 genes in colonic mucosa during colorectal cancer development

2021 ◽  
pp. 1-6
Author(s):  
Ben Kang ◽  
Hyun Seok Lee ◽  
Seong Woo Jeon ◽  
Soo Yeun Park ◽  
Gyu Seog Choi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Dna Methylation ◽  
Healthy Subjects ◽  
Large Scale ◽  
Methylation Status ◽  
Clinical Information ◽  
Field Cancerization ◽  
Aberrant Methylation ◽  
Clinical Value ◽  
Mortality And Morbidity

BACKGROUND: Colorectal cancer (CRC) is one of the leading causes of mortality and morbidity in the world. It is characterized by different pathways of carcinogenesis and is a heterogeneous disease with diverse molecular landscapes that reflect histopathological and clinical information. Changes in the DNA methylation status of colon epithelial cells have been identified as critical components in CRC development and appear to be emerging biomarkers for the early detection and prognosis of CRC. OBJECTIVE: To explore the underlying disease mechanisms and identify more effective biomarkers of CRC. METHODS: We compared the levels and frequencies of DNA methylation in 11 genes (Alu, APC, DAPK, MGMT, MLH1, MINT1, MINT2, MINT3, p16, RGS6, and TFPI2) in colorectal cancer and its precursor adenomatous polyp with normal tissue of healthy subjects using pyrosequencing and then evaluated the clinical value of these genes. RESULTS: Aberrant methylation of Alu, MGMT, MINT2, and TFPI2 genes was progressively accumulated during the normal-adenoma-carcinoma progression. Additionally, CGI methylation occurred either as an adenoma-associated event for APC, MLH1, MINT1, MINT31, p16, and RGS6 or a tumor-associated event for DAPK. Moreover, relatively high levels and frequencies of DAPK, MGMT, and TFPI2 methylation were detected in the peritumoral nonmalignant mucosa of cancer patients in a field-cancerization manner, as compared to normal mucosa from healthy subjects. CONCLUSION: This study identified several biomarkers associated with the initiation and progression of CRC. As novel findings, they may have important clinical implications for CRC diagnostic and prognostic applications. Further large-scale studies are needed to confirm these findings.

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