Personalized care for patients with Familial Adenomatous Polyposis after surgery
A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
This study is testing a personalized follow-up plan for people with familial adenomatous polyposis who have had surgery to see if it helps prevent cancer and manage their health better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT04678011 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of a personalized surveillance and intervention protocol for patients diagnosed with familial adenomatous polyposis (FAP) who have undergone prophylactic (procto)colectomy. FAP is a genetic condition that leads to the development of numerous polyps in the colon and rectum, significantly increasing the risk of colorectal cancer. The study will monitor patients post-surgery to manage and prevent the progression of adenomas and potential cancer development through tailored endoscopic surveillance and interventions. Participants will be followed over time to assess the outcomes of this personalized approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a confirmed diagnosis of FAP and have undergone prophylactic (procto)colectomy.
Not a fit: Patients who have active cancer at baseline endoscopy or those unable to have polyps removed during endoscopic procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this protocol could significantly reduce the risk of colorectal cancer in patients with FAP by providing tailored surveillance and intervention strategies.
How similar studies have performed: While personalized surveillance approaches have been explored in other contexts, this specific protocol for FAP post-surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of FAP, at least one of following: genetic diagnosis (proven APC germline mutation) and/or clinical diagnosis (\>100 colorectal adenomas in combination with a positive family history of FAP) * Have undergone prophylactic (procto)colectomy with IRA/ISA or IPAA * Age 18 years or older Exclusion Criteria: * Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies * Cancer at baseline endoscopy * Need for surgery
Where this trial is running
Houston, Texas and 1 other locations
- MD Anderson — Houston, Texas, United States (Recruiting)
- Academic Medical Centre — Amsterdam, North Holland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.