ABOUT THE STUDY

About

Why and What​

The FORTE study will compare the outcomes of two groups of patients. Patients in both groups will have had a previous colonoscopy with 1-2 small, non-advanced adenoma polyps. One group will undergo a follow-up colonoscopy at five and ten years. The second group will undergo a follow-up colonoscopy at ten years.​

Adenomas are not cancerous, but research has shown that adenomas can eventually grow into cancer if they are not surgically removed. Colonoscopies help identify and remove adenomas to lower the chance of colorectal cancer (CRC). Follow-up colonoscopies are recommended after adenomas are found and removed. Patients with 1-2 small, non-advanced adenomas are recommended by guidelines to return in 5-10 years for a follow-up colonoscopy. However, there are no guidelines on whether individuals should have a colonoscopy in 5 years as opposed to 10 years. Colonoscopies are an important tool to prevent CRC but there are certain risks and possible​ complications from colonoscopies. The FORTE Study may help us learn more about the best timing of follow-up colonoscopies that balance the benefits, risks, and discomforts of colonoscopies.

Who

The FORTE study will enroll 9,500 participants nationally. KPNC seeks to enroll about 2,000 of those participants. People who are eligible:

• Are between the ages of 45​-69.
• Had a previous colonoscopy within the last 4 years with 1-2 non-advanced adenomatous polyps (adenomas).
• Have not had another colonoscopy between the previous colonoscopy that found 1-2 small non-advanced adenomas and consenting into the study.

​There are additional criteria that would make someone eligible or ineligible for the Study. Study staff are happy to talk further if you are interested in taking part.

If you have questions about the FORTE study or are interested in joining, please email the KPNC FORTE study team at FORTEkpnc@kp.org or call us at (925) 520-1275.

Study Activities​

Participants in the FORTE Study are randomized into one of two groups:

• Group 1: Have a follow-up colonoscopy at both 5 years and 10 years after the last colonoscopy.
• Group 2: Have a follow-up colonoscopy 10 years after their​ last colonoscopy.

The FORTE study will determine whether having an extra colonoscopy at five years provides any benefit over having one at ten years. Both options follow guidelines for recommended care and follow what Kaiser Permanente doctors could recommend. We do not know which option is best, which is why we are doing this study.

If at any time a participant needs a colonoscopy outside of the 5- and 10-year window for health reasons, the study fully supports these needs. These participants can still stay in the study. We just ask that they let us know.

The FORTE Study also involves:

• Taking an online survey about health, family history, diet and lifestyle which takes about 20 minutes to complete.
• At home stool collection (three times), blood draw (once), and allowing the study to use any leftover colonoscopy polyp tissue samples for future studies.
• Being contacted at least once a year (by phone, mail or e-mail) to get updated information about health, results of colonoscopy exams, or other medical information.