Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT05994482

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

adenoma vs no adenoma

colonoscopy vs no colonoscopy

survey and expert panel

Study Details

Brief summary:

Colorectal cancer is a leading cause of cancer death. Detection and removal of polyps can reduce risk for developing colorectal cancer. After finding and removing precancerous polyps, repeat colonoscopy is routinely recommended. However, it is unclear whether repeat additional colonoscopy further reduces risk for colorectal cancer. For older adults age 75 and older, the lack of this information is especially important, given that the risks of colonoscopy go up with age. This research will evaluate whether older adults with a prior history of precancerous polyps have higher colorectal cancer risks compared to older adults who had a prior normal colonoscopy, and whether, among those with prior precancerous polyps, repeating a colonoscopy after age 75 is associated with reduced cancer risk. The investigators will synthesize these data and gather perspectives from Veterans and clinical stakeholders to make recommendations on whether older adults with a prior history of polyps should continue or defer colonoscopy after age 75.

Conditions

Colorectal Cancer

Study ID

NCT05994482

Start date

Oct 1, 2023

Status verified date

May, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Study Base and Inclusion Criteria, Aim 1:

  • The study base will consist of any Veteran alive at age 75 between 2005-2019, with exposure to a qualifying colonoscopy in the 10-year period prior to turning age 75
  • The investigators will include those with a qualifying colonoscopy associated with a colonoscopy note that can be processed by the previously established natural language processing (NLP) pipelines for extracting colonoscopy data from free-text reports60, 61 (see prior work below)
  • The colonoscopy done closest to, but prior to age 75 will be considered as a candidate qualifying colonoscopy
  • Date of cohort entry (start of follow up) will be defined as date at which a participant meeting inclusion criteria turned 75
  • Date of qualifying colonoscopy prior to age 75 will be defined as the qualifying colonoscopy reference date

Study Base and Inclusion Criteria for Cases and Subcohort, Aim 2:

  • The study base for Aim 2 consists of Veterans ages 75 and alive between 2003-2019 who had a polypectomy prior to turning age 75
  • Identification of the study base for Aim 2 will take a distinct approach from Aim 1
  • A candidate qualifying colonoscopy event will be defined by presence of a CPT code for colonoscopy associated with a pathology note-based diagnosis of an adenoma within 30 days of the CPT code for colonoscopy
  • The colonoscopy event occurring closest to, but prior to age 75 will be selected
  • From the study base, all individuals who developed incident or fatal CRC, and a random sample of the entire study base will undergo manual EHR chart review to confirm study eligibility
  • To identify candidate incident CRC cases, the investigators will identify all adults with a CRC diagnosis at ages 75, utilizing the Oncology Domain with the same strategy for incident CRC identification as described for Aim 1
  • To identify candidate fatal CRC cases, the investigators will identify all adults with a fatal CRC diagnosis at ages 75, using NDI cause-specific mortality data
  • To identify candidate members of the subcohort for chart review, a random sample of the study base will be drawn
  • This sample may include Veterans with and without subsequent CRC. Rationale for including Veterans with and without subsequent CRC (incident and/or fatal) in the control subcohort is well established
  • Specifically, if the investigators were to conduct a cohort study without sampling, then at the start of follow up, the cohort would include people with subsequent CRC
  • In a traditional cohort study, every CRC case contributes to the denominator of individuals at risk. Thus, by including in the subcohort Veterans with and without CRC on follow up, the investigators are able to calculate risk based on exposure to surveillance as if the investigators had conducted a cohort study utilizing the entire cohort

Inclusion Criteria, Aim 3a:

Participant selection for qualitative interviews. Patient Selection:

  • The investigators will use EHR data to generate a list of VASDHS and VAGLA patients who have:

  • a) age 75
  • b) history of colonoscopy with polypectomy in the past 10 years
  • c) been referred for surveillance colonoscopy
  • The investigators will randomly select patients, recruiting until the investigators have 12 who completed surveillance colonoscopy and 12 who have not completed surveillance
  • The investigators will monitor the sample to assure sex balance consistent with VA demographics for patients who have had colonoscopy (98.2% male and 1.8% females age 75)
  • The investigators will also ensure that at least one- third of sampled patients have moderate or severe frailty based on the claims-based VA-FI36, 64 and make efforts to maintain patient racial/ethnic and geographic (i.e. San Diego/Los Angeles areas) diversity

Provider Selection:

  • The investigators will conduct interviews with 20 providers, specifically 10 primary care providers (including 3-4 geriatricians) and 10 gastroenterologists
  • The investigators will select providers from a randomly generated list of practicing VA clinicians (5/8th or greater) at VASDHS or VAGLA
  • If the investigators experience challenges reaching the target sample size, the investigators will employ snowball sampling by asking participants to name other potentially eligible clinicians
  • The investigators anticipate reaching thematic saturation given > 17 interviews in each group and have made provisions to accommodate up to 6 additional patient and/or provider interviews if new themes continue to arise by the end of the planned interviews
  • The investigators will make efforts to achieve geographic balance to ensure provider representation from VASDHS and VAGLA

Participant selection for expert panel:

  • The investigators will convene a group of 15-20 multi-level stakeholders for the in-person expert panel in Quarter 1 of Year 4
  • The panel will include VA patients and caregivers (not included in Aim 3a):

  • VA providers
  • VA leadership and policymakers
  • health services and clinical researchers
  • individuals with non-VA healthcare systems perspectives

Exclusion Criteria:

Study Base and Exclusion Criteria, Aim 1:

  • History of CRC prior to age 75
  • History of sessile serrated adenoma/polyp/lesion (SSL), traditional serrated adenoma (TSA), or large serrated polyp (LSP, defined as hyperplastic polyp >10mm) at qualifying colonoscopy
  • History of inflammatory bowel disease (IBD) prior to age 75
  • Absence of exposure to normal colonoscopy or colonoscopy with polypectomy between ages 65-75

Study Base and Exclusion Criteria for Cases and Subcohort, Aim 2:

  • All candidate CRC cases and members for the subcohort will be included in the analytic sample unless they meet one of the following exclusion criteria:

  • absence of a reviewable colonoscopy note
  • absence of polypectomy with adenoma diagnosis at candidate qualifying colonoscopy event
  • presence of a SSL, TSA, or LSP
  • history of CRC or IBD
  • history of hereditary cancer syndrome (this criteria is not used for Aim 1 because it cannot be reliably assessed with structured EHR data)

Study Design

Enrollment

130000 participants

Anticipated

Interventions and Outcome Measures

Arms

Older adults

Aim 1: Older adults with and without a prior history of precancerous polyps

Older adults with prior polypectomy

Aim 2: Older adults with a prior history of precancerous polyps, exposed vs unexposed to surveillance colonoscopy

Stakeholders

Aim 3: Veterans, clinical, and policy stakeholders who will provide input and participate in an expert panel to synthesis available evidence on pros/cons of surveillance in older adults.

Interventions

adenoma vs no adenoma

For Aim 1, the investigators will examine colorectal cancer risk among older adults with prior removal of a precancerous polyp (adenoma) vs a prior normal colonoscopy

colonoscopy vs no colonoscopy

For Aim 2, the investigators will examine colorectal cancer risk among older adults with prior history of polypectomy, exposed vs unexposed to subsequent surveillance colonoscopy

survey and expert panel

The investigators will conduct 44 semi-structured one-on-one qualitative interviews with VA patients (older adults) and providers (primary care, GI, geriatrics) to understand perspectives on CRC risk, and potential benefits and harms of surveillance (Aim 3a). The investigators will then convene an expert panel with key stakeholders including Veterans, primary providers, geriatricians, gastroenterologists, VA leaders, and policy makers to present Aim 1, 2, and 3a findings (Aim 3b). The primary outcome will be specific recommendations regarding use of surveillance colonoscopy in older adults, ranked by priority and feasibility, that can guide VA policy around future implementation (or de-implementation) of surveillance among older adults.

Primary outcome measure

  • colorectal cancer incidence [ Time Frame: at anytime during follow up, ranging up to 20 years. ]

Central Contacts and Locations

Central contacts

Locations

VA San Diego Healthcare System, San Diego, CA

Recruiting

San Diego, California, United States, 92161-0002

Contacts

Principal Investigator:

Samir Gupta, MD MS

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Recruiting

West Los Angeles, California, United States, 90073-1003

Contacts

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • colorectal cancer
  • older adults
  • aging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-12.