Evaluating the Cologuard Test for Use in Lynch Syndrome

NCT04778566 | Withdrawn

• 1 other identifier: 2020-0239
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aiming to enroll 90 patients with genetically confirmed Lynch Syndrome (LS) from Geisinger's High Risk Colorectal Cancer Clinic (HRC). Upon enrollment in the study, a Cologuard test will be ordered and the results will be blinded until data analysis. Patients enrolled in the study will also undergo a colonoscopy as part of their routine HRC visit.

Conditions

Lynch Syndrome; Colorectal Cancer; Colonic Adenoma; Colonic Polyp

Keywords

Lynch Syndrome; Colorectal Cancer; Hereditary non-polyposis colon cancer; High-Risk Colon Cancer; Health-Related Quality of Life; Bowel Prep Tolerability; Colonoscopy; Procedural anxiety

Outcome Measures

Primary Outcomes (1)

• Evaluate the feasibility of the Cologuard test for Lynch Syndrome

  To evaluate the feasibility of Cologuard in a high-risk population, a summary report of the enrollment/consent rate and adherence to the protocol will be provided. Additional analyses comparing the results (given as positive/negative) Cologuard with the gold standard of colonoscopy will be performed using diagnostic tests including sensitivity, specificity, positive predictive value and negative predictive value.

  3 months

Secondary Outcomes (5)

• Evaluate patient satisfaction with Cologuard

  3 months

• Evaluate health-related quality of life in Lynch Syndrome

  3 months

• Evaluate depressive symptoms

  3 months

• Evaluate anxiety symptoms surrounding routine colonoscopy

  3 months

• Evaluate bowel preparation tolerability

  3 months

Study Arms (1)

Cologuard Study Group

Within 60 days of their already scheduled screening colonoscopy, participants will provide a stool sample to be tested by a Cologuard screening test kit. Participants will also complete surveys prior to their colonoscopy as well as post colonoscopy.

Diagnostic Test: Cologuard test

Interventions

Cologuard test DIAGNOSTIC_TEST

Cologuard is a stool-DNA screening test for detecting colon cancer

Cologuard Study Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients being followed in the HRC with a diagnosis of LS

You may qualify if:

• Patients age 18-89
• Diagnosis of genetically confirmed LS
• Scheduled for standard of care colonoscopy within 60 days of enrollment

You may not qualify if:

• Diagnosis of other inherited genetic disorders that increase risk for Colorectal Cancer (CRC) (Familial Adenomatous Polyposis (FAP), Cowden's syndrome, Turcot syndrome, Gardner syndrome, and Peutz-Jeghers syndrome)
• Diagnosis of other inherited Inflammatory bowel disease (i.e. Crohn disease, ulcerative colitis)
• Participation in any interventional clinical study within the previous 30 days
• Personal history of CRC not in full remission (5 consecutive cancer-free years)
• Current active treatment with chemotherapy
• Treatment with chemotherapy within 12 months prior to consent date

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Health

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rajiv Panikkar, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor - Investigator

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: November 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)