RecruitingNAINTERVENTIONAL

Colonoscopy vs Stool Testing for Older Adults With Colon Polyps

This research is looking at better ways to follow up with older adults, aged 65 to 82, who have had colon polyps removed. Currently, many people have regular colonoscopies, but these can have risks and be inconvenient, especially for older individuals. This study will compare the usual colonoscopy checks with a simple, at-home stool test called FIT (Faecal Immunochemical Test). The aim is to find out if the FIT test is just as good, or even better, concerning safety and ease for older people who have had low-risk polyps. The findings could change how we monitor for colon cancer in the future, making it easier and safer for many.

At a glance

Status

Recruiting

Phase

Sponsor

Dartmouth-Hitchcock Medical Center

Enrolment target

8,946

Start

14 Jun 2023

Estimated completion

31 Dec 2035

Colorectal Polyp Colorectal Neoplasms Colorectal Adenoma Colorectal Cancer Digestive System Disease

What is this study about?

When people get older, often over 50, it's common to find small growths called polyps in the bowel. Most polyps are harmless, but some can turn into bowel cancer over time. Because of this, doctors usually recommend regular checks, often a procedure called a colonoscopy, to make sure any new polyps are found and removed early. This study is specially designed for people aged 65 to 82 who have previously had polyps and are due for their next check-up.

We know that colonoscopies can be really helpful, but for some older people, they might also carry more risks, like bleeding or discomfort, and can be quite a hassle. Also, if someone has other serious health conditions, the benefits of repeated colonoscopies might be less clear. This means we need more options for checking on polyps regularly that are both safe and easy for older adults. This research aims to address these important questions.

This study is going to compare the usual colonoscopy checks with a different method: a simple home test where you provide a stool sample (poo test) called a FIT. The FIT test is already used widely to screen for bowel cancer and is much less invasive than a colonoscopy. Many countries already use it for monitoring certain types of polyps. We want to see if the FIT test works just as well as, or even better than, colonoscopies for older people who have had simpler types of polyps, to help guide future advice and care.

Key takeaways

Compares bowel scope (colonoscopy) vs. home stool test (FIT) for older adults.
For people aged 65-82 with a history of low-risk bowel polyps.
Aims to find a safer, easier way to monitor bowel health for this age group.
Could change future guidelines for polyp checks.
Participation involves either annual colonoscopies or annual FIT tests at home.

Who may be eligible?

To join this study, you need to be between 65 and 82 years old and have had polyps removed from your bowel in the past. Your most recent bowel scope (colonoscopy) should have shown two or fewer polyps that were not considered 'advanced' (meaning they were low-risk). You should also be due for your next routine bowel check-up within the next year and be able to understand and sign the consent forms.

The study cannot include everyone. For example, you can't take part if you've already had bowel cancer, or if you have certain genetic conditions that greatly increase your risk of bowel cancer. People with inflammatory bowel diseases like Crohn's or ulcerative colitis are also not suitable. If your last colonoscopy found three or more polyps, or any advanced polyps, you also wouldn't be able to join.

Finally, if you have other serious health problems that mean it wouldn't be safe or helpful for you to have regular polyp checks – for example, severe heart, lung, or kidney disease, a recent stroke, dementia affecting daily life, or a very recent cancer diagnosis – then this study wouldn't be right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 65 and 82 years old?
Have you had bowel polyps removed in the past?
Did your last bowel scope show 2 or fewer non-advanced polyps?
Are you due for your next routine bowel check in the next 12 months?
Do you not have a personal history of bowel cancer or serious bowel conditions like Crohn's disease?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups. One group will continue with annual colonoscopies as they normally would for their polyp surveillance. The other group will be asked to do an at-home stool test (FIT test) annually instead of a colonoscopy. There will be no extra clinic visits beyond what is already part of your usual care, but you would be providing stool samples or attending colonoscopy appointments depending on your assigned group. The study will track your health over a period of time to compare the two methods.

Potential risks and benefits

Taking part in this study could offer you the benefit of potentially finding a less invasive and more convenient way to monitor your bowel health, especially if you are in the stool test group. You would also be contributing to important research that could improve care for many older adults in the future. However, there are also potential risks related to each method: colonoscopies carry a small risk of complications like bleeding or perforation, while relying on a stool test might mean a polyp could be missed and grow larger before detection, though this study aims to assess that very risk. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (22)

University of Alabama Birmingham
Verified postcode
Birmingham, United States· Active not recruiting
University of Arizona
Verified postcode
Tucson, United States· Recruiting
Jennifer Moreno Department of Veterans Affairs Medical Cneter
Verified postcode
San Diego, United States· Recruiting
Kaiser Permanente Northern California
Verified postcode
Walnut Creek, United States· Recruiting
University of Colorado
Verified postcode
Aurora, United States· Recruiting
MedStar Health
Verified postcode
Washington D.C., United States· Recruiting
James A. Haley Veterans Hospital
Verified postcode
Tampa, United States· Recruiting
Northwestern Memorial Hospital
Verified postcode
Chicago, United States· Recruiting
Richard L. Roudebush VA Medical Center
Verified postcode
Indianapolis, United States· Recruiting
University of Michigan Health
Verified postcode
Ann Arbor, United States· Recruiting
Henry Ford
Verified postcode
Detroit, United States· Recruiting
Dartmouth Health
Verified postcode
Lebanon, United States· Recruiting

Common questions

What is a colon polyp?

A colon polyp is a small growth on the lining of your bowel. Most are harmless, but some can turn into cancer over time, so doctors usually recommend checking them regularly.

What is a FIT test?

FIT stands for Faecal Immunochemical Test. It's a simple, at-home test where you collect a small sample of your stool (poo) to check for hidden blood, which can be a sign of issues in your bowel.

Why is this study important for older adults?

For older adults, repeated colonoscopies can be more risky or difficult. This study hopes to find a safer, easier way to check for polyps that works well for people aged 65-82.

Will I have to pay to join the study?

Clinical trials usually cover the costs of study-related tests and procedures, but you should always confirm this with the study team before joining.

What if a polyp is found during the study?

If a polyp or any other concern is found, the study team will ensure you receive the appropriate follow-up and care, just as you would under standard medical practice.

How to find out more

Barbie Patel, MPH

coopstudy@hitchcock.org 857-4987233 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.