Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Receipt of mailed Cologuard test for colorectal cancer screening to be completed and returned by participant. If test is negative, participant will be advised to undergo another test in 3 years. If test is positive, participant will be advised to schedule colonoscopy for further testing.

Receipt of mailed FIT for colorectal cancer screening to be completed and returned by participant. If test is negative, participant will be advised to undergo another test in 1 year. If test is positive, participant will be advised to schedule colonoscopy for further testing.

Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.

Cologuard

Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.

Fecal Immunochemical Test

Joshua Demb, PhD, MPH

Samir Gupta, MD, MSCS

Joshua Demb, PhD

The objective of this pilot study is to compare the effectiveness of mailed outreach of two stool based tests, Cologuard and the fecal immunochemical test (FIT) in screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.

Adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. Eligible participants will be randomized to either mailed Cologuard outreach, facilitated by Exact Sciences or mailed FIT outreach. Colorectal cancer screening completion within 3 months will be measured as the primary outcome, in addition to secondary recruitment and intervention-based feasibility outcomes to demonstrate the potential for a larger randomized controlled trial.

Two-arm intervention trial comparing mailed Cologuard outreach (intervention) to mailed FIT outreach (control)

Head to Head Mailed Cologuard to Mailed FIT

Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach

The proportion of individuals who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)

Among those completing designed interventions (Cologuard or FIT), the proportion of test results yielding an abnormal result.

Among those with positive stool blood test results, the proportion who complete diagnostic follow-up colonoscopy

Measurement of feasibility of mailed outreach

Measurement of number of adenomas detected during study period

Measurement of number of sessile serrated lesions detected during study period

Number of colorectal cancers detected during study period

University of California, San Diego

Postdoctoral Scholar

Subjects will receive the usual care pertaining to colorectal cancer (CRC) screening according to their respective clinical site and will not view either of the study videos.

Subjects will watch a video pertaining to the importance of CRC screening.

Subjects will watch the same video as described in Arm 2, immediately followed by a second video pertaining to 3 CRC screening modalities: colonoscopy, FIT, and Cologuard.

Videos about colorectal cancer screening.

Brief Video

Videos about colorectal cancer screening and modalities.

Brief Video Plus

Joan M. Griffin, PhD

John Inadomi, MD

Charles R. Rogers, PhD

The primary objective of this study is to evaluate the impact of a theoretically grounded video that includes information about CRC screening modality choices on CRC screening rates and time adherent to CRC guidelines.

Subjects 45 to 70 years of age, scheduled for a primary care (index) appointment, at average risk for colorectal cancer (CRC), and due for CRC screening will be enrolled in the study. Subjects will be randomized to one of three intervention arms: no video (arm 1), brief CRC screening video (arm 2), or enhanced CRC screening video (arm 3). Subjects in all intervention arms will complete surveys regarding intention to screen for CRC and preference for screening modality prior to viewing the video, after the video, and after their index appointment. Subjects will be surveyed, and medical information collected, annually for up to six years to assess adherence to CRC screening and CRC screening outcomes.

Informed Choice - Compass

Informed Choice Intervention for Colorectal Cancer Screening: Compass

Individual participant data that underlie the results reported in publications of the study may be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and clinical study report (when applicable) may also be shared. Data will be available from 2 years and ending 4 years after publication. Data may be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

The percentage of time that subjects are colorectal cancer screening guideline adherent based on recommended screening interval for chosen method from the time of the index appointment to 1 year.

The percentage of time that subjects are colorectal cancer screening guideline adherent based on recommended screening interval for chosen method from the time of the index appointment to 3 years.

The percentage of time that subjects are colorectal cancer screening guideline adherent based on recommended screening interval for chosen method from the time of the index appointment to 6 years.

Mayo Clinic

University of Utah

American Cancer Society, Inc.

F!ght Colorectal Cancer

Exact Sciences Corporation

Those whose Cologuard T0 result was positive and colonoscopy result was negative.

Those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol.

Those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative.

Those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol.

The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.

Subjects who consented to enroll in Exact Sciences Protocol 2014-01, that fit one of the following sub-populations, will be asked to participate in the sub-study. Population 1 includes those whose Cologuard T0 result was positive and colonoscopy result was negative. Population 2 includes those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol. Population 3 includes those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. Population 4 includes those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. Subjects that enrolled in the Exact Sciences Protocol 2014-01, who provided written informed consent to participate in this sub-study, will asked to complete the Follow-Up Questionnaire during a phone interview.

Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)

Observational Study of Sub-populations From "A Longitudinal Study of Cologuard in an Average Risk Population Assessing a Three Year Test Interval"/Protocol 2014-01 Post-Approval Study

A medical chart review and phone interview will be conducted for each subject. The Follow-Up Questionnaire will be completed during the phone interview.

Hematinics

All Drugs and Chemicals

Gastrointestinal Agents

Liver Extracts

Pancrelipase

Pancreatin

Subjects with clinically confirmed breast cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects with clinically confirmed lung cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects with clinically confirmed colorectal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects with clinically confirmed prostate cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects with clinically confirmed uterine cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects with clinically confirmed or suspicion of kidney/renal pelvis cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects with clinically confirmed liver cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects with clinically confirmed or suspicion of pancreatic cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects with clinically confirmed stomach cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects with clinically confirmed esophageal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.

Subjects participating in the study will provide a stool sample within 30 days of enrollment.

Stool Sample Collection

The primary objective of this sub-study is to obtain de-identified, clinically characterized, stool specimens from subjects with untreated solid tumors for research use in the development and validation of a stool-based test for colorectal cancer.

Stool Collection Sub-Study of Exact Sciences Protocol 2018-01

Stool Collection Sub-Study of Exact Sciences Protocol 2018-01: "Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.

Research for the development and validation of a stool-based test for colorectal cancer

Colonic Neoplasms

Herbal and Botanical

Cola

Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.

multi-target stool Deoxyribonucleic Acid (MT-sDNA) screening test

The purpose of this study is to gather information about the long term health of people who have been prescribed the Cologuard test, which is used for colorectal cancer (CRC) screening.

Participates will be consented for prospective follow-up for health outcomes, which will be ascertained through periodic contacts. Participants will complete a baseline health questionnaire survey (T0) and a 1-year follow-up questionnaire survey (T1), allow access to medical records, when available, and allow future contacts for additional surveys.

Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality

Individual participant data that underlie the results reported in publications of the study will be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol (including statistical methods), informed consent form, and clinical study report will also be shared. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

Proportion having diagnostic colonoscopy within 1 year after positive CG test

Comparison with national rates (i.e., SEER cancer registry rates) adjusted to reflect a) the age- and sex- distribution of CG users, b) that 25% of colorectal cancers occur in high risk patients, and c) the attrition rate of our longitudinal cohort

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Head to Head Mailed Cologuard to Mailed FIT	NCT06173375	Colorectal Canc...	Cologuard Fecal Immunoche...	45 Years - 49 Years	University of California, San Diego
Informed Choice - Compass	NCT05246839	Colorectal Canc...	Brief Video Brief Video Plu...	45 Years - 70 Years	Exact Sciences Corporation
Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)	NCT03705013	Colorectal Canc...	Cologuard	50 Years -	Exact Sciences Corporation
Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)	NCT03705013	Colorectal Canc...	Cologuard	50 Years -	Exact Sciences Corporation
Head to Head Mailed Cologuard to Mailed FIT	NCT06173375	Colorectal Canc...	Cologuard Fecal Immunoche...	45 Years - 49 Years	University of California, San Diego
Stool Collection Sub-Study of Exact Sciences Protocol 2018-01	NCT04473625	Colorectal Canc... Colo-rectal Can... Cancer	Stool Sample Co...	18 Years -	Exact Sciences Corporation
Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality	NCT04124406	Colon Cancer	Cologuard	18 Years -	Exact Sciences Corporation
Stool Collection Sub-Study of Exact Sciences Protocol 2018-01	NCT04473625	Colorectal Canc... Colo-rectal Can... Cancer	Stool Sample Co...	18 Years -	Exact Sciences Corporation
Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality	NCT04124406	Colon Cancer	Cologuard	18 Years -	Exact Sciences Corporation
Head to Head Mailed Cologuard to Mailed FIT	NCT06173375	Colorectal Canc...	Cologuard Fecal Immunoche...	45 Years - 49 Years	University of California, San Diego

Spots Global Cancer Trial Database for cologuard

Every month we try and update this database with for cologuard cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cologuard

Every month we try and update this database with for cologuard cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cologuard cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.