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Colorectal CancerSOANCT05994482

Surveillance Colonoscopy in Older Adults: The SurvOlderAdults Study

An observational study of Colorectal Cancer, run by VA Office of Research and Development at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
adenoma vs no adenoma, colonoscopy vs no colonoscopy and survey and expert panel
How many people
63 participants
Where
2 sitesUnited States
Study dates
1 Oct 2023to 30 Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Older adults at risk for colorectal cancer

Who may be able to join

  • 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 reports (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
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  • 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 colorectal cancer (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
  • 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

Who cannot join

  • Study Base and Exclusion Criteria, Aim 1:
  • History of colorectal cancer (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 >10 millimeters) 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:
Show all 12Show fewer
  • 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 sessile serrated adenoma/polyp/lesion (SSL), traditional serrated adenoma (TSA), or large serrated polyp (LSP)
  • history of CRC or inflammatory bowel disease (IBD)
  • history of hereditary cancer syndrome (this criteria is not used for Aim 1 because it cannot be reliably assessed with structured electronic health record (EHR) data)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161-0002

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

    West Los Angeles, California, 90073-1003

Other trials in United States

About this study

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.

Read the detailed description

Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the United States (US), with 149,500 new CRC cases, and 52,980 deaths expected in 202119; 4,000 Veterans are diagnosed with CRC annually. Screening for CRC reduces incidence and mortality, in part due to detection and removal of polyps such as adenomas. National and VA guidelines recommend surveillance colonoscopy after adenoma removal (defined herein as polypectomy), but the incremental benefit of surveillance after polypectomy on reducing CRC incidence and mortality are uncertain. For adults age 75 and older ("older adults") considering surveillance colonoscopy, these issues are of particular importance. Harms associated with colonoscopy increase dramatically with age, with 3.8% to 6.8% of older adults experiencing an emergency visit or hospitalization within 30 days of colonoscopy. Older vs. younger adults have a 1.5 to 3.7-fold increase in post-colonoscopy complications. Older adults also are less likely to live long enough to benefit from interventions such as surveillance colonoscopy, due to competing, non-CRC mortality risks. The well-established age-related increasing risks for competing causes of mortality and colonoscopy-related harms stand in sharp contrast to major evidence gaps: it is unclear whether CRC risk is clinically significant among older adults with prior history of polyps, and whether exposing older adults to surveillance reduces CRC risk. Yet, the default clinical paradigm is for many older adults to receive surveillance colonoscopy. In the VA, surveillance is a very common indication for colonoscopy among older Veterans, with an estimated >17,400 exposed to surveillance annually. The mismatch between available evidence and current clinical practice, coupled with extreme constraints on colonoscopy resources in the VA, make the surveillance colonoscopy paradigm an ideal focus area for quantifying risks and benefits to optimize health outcomes. The Overarching Aim is to advance knowledge on CRC risks among older adults with prior polypectomy and potential benefits of surveillance colonoscopy, with the goal of informing policies and clinical strategies that optimize benefits, risks, and resource utilization. The Specific Aims are to:

Aim 1. Compare cumulative CRC risk after age 75 in a cohort of older adults with history of normal colonoscopy (n=101,328) vs. colonoscopy with polypectomy (n=29,548) prior to age 75. After normal colonoscopy, US Preventive Services Task Force guidelines note that benefits of repeat screening in older adults are likely minimal and recommend selective screening. Finding no CRC risk difference for older adults with prior normal colonoscopy vs. polypectomy would suggest surveillance guidelines should follow a similar approach. Risk analyses will also be stratified by baseline adenoma type (low vs. high risk). Hypothesis: Cumulative risk for incident CRC (primary analysis) and fatal CRC (secondary analysis) after age 75 will be similar in older adults with normal colonoscopy vs. colonoscopy with polypectomy prior to age 75.

Aim 2. Among older adults with polypectomy prior to age 75, assess comparative effectiveness of exposure vs. no exposure to surveillance colonoscopy after age 75 for reducing CRC risk using a case-cohort design. Cases with incident (n=270) and fatal CRC (n=150), and a random sample subcohort with prior polypectomy (n=1,036) will undergo rigorous chart review to ascertain exposure to surveillance colonoscopy. Harms associated with surveillance will be characterized. Risk analyses will also be stratified by baseline adenoma type (low vs. high risk). Hypothesis: Older adults unexposed vs. exposed to surveillance will have similar risk for incident CRC (primary analysis) and fatal CRC (secondary analysis).

Aim 3. Obtain multi-level stakeholder perspectives regarding CRC risk and surveillance outcomes to inform future use and VA policy regarding surveillance colonoscopy in older Veterans. 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.

Impact: Establishing CRC risk among older adults with prior polypectomy, and outcomes associated with surveillance, will fill critical evidence gaps and inform guidelines within and outside VA. Multi-stakeholder perspectives on CRC risk and surveillance outcomes will pave the way for future implementation of evidence-based, Veteran-centric, and optimized value strategies for surveillance among older adults. This work will also serve as a model for leveraging VA data to address an important population health challenge for the VA's large and growing older adult population, and to use these data to engage Veterans, healthcare providers, and policy makers in identifying interventions which can be scaled and sustained to optimize outcomes.

Being tested
adenoma vs no adenoma, colonoscopy vs no colonoscopy, survey and expert panel
Keywords
colorectal cancer, older adults, aging
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adenoma vs no adenomaOther

    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 colonoscopyOther

    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 panelOther

    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.

Study groups in NCT05994482
Study groupRoleWhat they receive
Older adultsAim 1: Older adults with and without a prior history of precancerous polyps
Receives: Other: adenoma vs no adenoma
Older adults with prior polypectomyAim 2: Older adults with a prior history of precancerous polyps, exposed vs unexposed to surveillance colonoscopy
Receives: Other: colonoscopy vs no colonoscopy
StakeholdersAim 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.
Receives: Other: survey and expert panel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. colorectal cancer incidence

    colorectal cancer

    Measured: at anytime during follow up, ranging up to 20 years

Secondary outcomes (2)
  1. colorectal cancer mortality

    colorectal cancer death

    Measured: at anytime during follow up, ranging up to 20 years

  2. perspectives on surveillance in older adults

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2023
  2. Study start1 Oct 2023
  3. Primary completion30 Sep 2026
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05994482
Sponsor's protocol ID
IIR 22-007
Other IDs
5I01HX003605-03
Acronym
SOA
Status last verified
Oct 2026
First submitted
3 Aug 2023
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38081492
  • 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.

    PubMed 40518061
  • 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.

    PubMed 40146011
  • Gupta S, Liu L, Demb J, Qin J, Earles A, Lamm M, Huang X, Shah SC, Chawla N, Le Y, Loeb TB, Dominitz JA, Robertson DJ, Schoenborn NL, Calderwood AH, Levin TR, Seligman BJ, May FP. Colorectal Cancer and Mortality Risk Among Older Adults With vs Without Adenoma on Prior Colonoscopy. JAMA. 2026 May 5;335(17):1499-1506. doi: 10.1001/jama.2026.3414.

    PubMed 41954928

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

colorectal cancer incidence (time frame: at anytime during follow up, ranging up to 20 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05994482, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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