Surveillance Colonoscopy in Older Adults: The SurvOlderAdults Study

NCT05994482 | Recruiting

• 1 other identifier: IIR 22-007
• Study Type: observational
• Target: 130,000
• Locations: 1 country
• Sites: 2

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

Keywords

colorectal cancer; older adults; aging

Outcome Measures

Primary Outcomes (1)

• colorectal cancer incidence

  colorectal cancer

  at anytime during follow up, ranging up to 20 years.

Secondary Outcomes (2)

• colorectal cancer mortality

  at anytime during follow up, ranging up to 20 years

• perspectives on surveillance in older adults

  cross sectional one time - the interviews and panel will be done over a 1 year time period.

Study Arms (3)

Older adults

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

Other: adenoma vs no adenoma

Older adults with prior polypectomy

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

Other: colonoscopy vs no 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.

Other: survey and expert panel

Interventions

adenoma vs no adenoma OTHER

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

Older adults

colonoscopy vs no colonoscopy OTHER

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

Older adults with prior polypectomy

survey and expert panel OTHER

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.

Stakeholders

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Older adults at risk for colorectal cancer

You may qualify if:

• 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 qualifying colonoscopy prior to age 75 will be defined as the qualifying colonoscopy reference date
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

RECRUITING

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

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

RECRUITING

Related Publications (3)

• Gupta S, May FP, Kupfer SS, Murphy CC. Birth Cohort Colorectal Cancer (CRC): Implications for Research and Practice. Clin Gastroenterol Hepatol. 2024 Mar;22(3):455-469.e7. doi: 10.1016/j.cgh.2023.11.040. Epub 2023 Dec 9.

  PMID: 38081492 RESULT

• Pandita P, Le Y, Trivedi M, Heskett K, Demb J, Singh S, Sullivan BA, Liu L, Gupta S. Yield of Advanced Neoplasia at Second Post-polypectomy Surveillance Colonoscopy: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2025 Dec;23(13):2448-2458.e5. doi: 10.1016/j.cgh.2025.02.038. Epub 2025 Jun 13.

  PMID: 40518061 RESULT

• Qin J, Earles A, Lamm M, Yassin H, Demb J, Liu L, Gupta S. Characteristics of Postpolypectomy Colorectal Cancer Events and Deaths. Am J Gastroenterol. 2025 Nov 1;120(11):2692-2702. doi: 10.14309/ajg.0000000000003430. Epub 2025 Mar 27.

  PMID: 40146011 RESULT

Biospecimen

Retention: NONE RETAINED

No biospecimens

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Samir Gupta, MD MS

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

• Folasade Popoola May, MD MSPH PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samir Gupta, MD MS

CONTACT

(858) 552-8585; samir.gupta@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 16, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)