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Familial Adenomatous Polyposis clinical trials

View clinical trials related to Familial Adenomatous Polyposis.

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NCT ID: NCT06308445 Not yet recruiting - Clinical trials for Familial Adenomatous Polyposis

Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis

RAPA-4-PAF
Start date: August 1, 2024
Phase: Phase 2
Study type: Interventional

The hypothesize of this research is that rapamycin is effective and well-tolerated in teenagers with familial adenomatous polyposis (FAP). Rapamycin could be effective in blocking the formation of adenomas and/or their evolution by decreasing their size and number. Researchers aim to assess the safety profile of rapamycin in FAP adolescents using a 2 low dose regimen.

NCT ID: NCT06163365 Recruiting - Lynch Syndrome Clinical Trials

Inherited Cancer Early Diagnosis (ICED) Study

ICED
Start date: July 26, 2022
Phase:
Study type: Observational [Patient Registry]

ICED is a prospective sample collection research study, aiming to develop or validate a blood/urine biomarker which could potentially detect cancers early in individuals at high risk of developing cancers, due to certain germline alterations.

NCT ID: NCT05657145 Enrolling by invitation - Clinical trials for Familial Adenomatous Polyposis

Visualization of the Papilla Through Use of the NuView Device in Patients With FAP

NuView
Start date: January 27, 2023
Phase:
Study type: Observational

The goal of this observational study is to test the NuView device in participants with familial adenomatous polyposis (FAP). The main question it aims to answer is: - can the papilla be visualized using a forward-facing endoscope outfitted with the NuView device. Participants will undergo standard of care esophagogastroduodenoscopy with an additional endoscopic exam using NuView device, for which participant have given prior consent.

NCT ID: NCT05630794 Not yet recruiting - Clinical trials for Colorectal Carcinoma

Testing ONC201 to Prevent Colorectal Cancer

Start date: March 1, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety, side effects, and best dose of Akt/ERK Inhibitor ONC201 (ONC201) in preventing colorectal cancer in patients with familial adenomatous polyposis (FAP) or a history of multiple polyps. ONC201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT05552755 Recruiting - Clinical trials for Familial Adenomatous Polyposis

Evaluate REC-4881 in Patients With FAP

TUPELO
Start date: July 10, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, two-part trial in participants with Familial Adenomatous Polyposis (FAP).

NCT ID: NCT05402891 Enrolling by invitation - Clinical trials for Familial Adenomatous Polyposis

The CHAMP-study: The CHemopreventive Effect of Lithium in Familial AdenoMatous Polyposis

Lithium in FAP
Start date: June 2, 2022
Phase: Phase 2
Study type: Interventional

Rationale: Familial adenomatous polyposis (FAP) syndrome is characterized by the development of numerous colorectal polyps. If left untreated, these patients have a chance of nearly 100% of developing colorectal cancer (CRC) at a young age. Therefore, guidelines recommend a prophylactic colectomy during early adulthood. Even after colectomy, most patients will develop adenomas in the retained rectum or ileoanal pouch requiring further endoscopic surveillance. In a recent study in mouse models, a chemopreventive effect of Lithium was observed on the spread of Apc mutated cells within the crypts of normal intestinal mucosa, suggesting polyp formation can be prevented. Lithium is used to treat patients with bipolar disorders but has never been investigated in patients with FAP aiming to reduce polyp burden. We hypothesize that Lithium could reduce the spread of APC mutated cells within the crypt of normal intestinal mucosa potentially reducing polyp burden in patients with FAP. Objective: The aim of this study is to investigate the effect of low-dose Lithium on stem cell dynamics, the number and size of polyps and, to assess safety outcomes of this drug in FAP patients. Study design: A prospective phase II, single arm pilot trial, with a duration of 18 months. The drug will be administered between month 6 and 12. Study population: Twelve patients with FAP between the age of 18 and 35 not having undergone a colectomy (yet), having a genetically confirmed APC mutation and a family history with a classical FAP phenotype. Intervention: All patients will be treated with Lithium with an oral dose of 300mg a day for six months, achieving a therapeutic serum level between 0.2-0.4 mmol/L. Main study parameters/endpoints: The main outcome parameter is the effect of Lithium on the spread of APC mutant cells within intestinal crypts over time by using an APC specific marker NOTUM (a significance reduce of fixed crypts and reduction of fixed clone size of 50%). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: A physical examination and an endoscopy with biopsies will be performed at baseline and every six months (four in total). Laboratory testing will be done at baseline and every two months during Lithium treatment. Patients will be interviewed by phone and Lithium side effect questionnaires will be obtained at baseline and during Lithium treatment. Lithium serum levels will be measured at day 12 and 22 after start of the study drug (at month 6). When the therapeutic range has been achieved, serum level testing will be done every month. Most relevant side-effects that could potential occur include polyuria, hyperparathyroidism and hypothyroidism. Most side effects are dose-dependent and will be regularly monitored. Patients with FAP could potentially benefit from a chemopreventive therapy such as Lithium to postpone or even avoid invasive types of surgery.

NCT ID: NCT05223036 Recruiting - Clinical trials for Colorectal Carcinoma

Testing Obeticholic Acid for Familial Adenomatous Polyposis

Start date: September 19, 2022
Phase: Phase 2
Study type: Interventional

This phase IIa trial investigates if giving obeticholic acid (OCA) is safe and has a beneficial effect on the number of polyps in the small bowel and colon in patients with familial adenomatous polyposis (FAP). FAP is a rare gene defect that increases the risk of developing cancer of the intestines and colon. OCA is a drug similar to a bile acid the body makes. It is fluid made and released by the liver. OCA binds to a receptor in the intestine that is believed to have a positive effect on preventing cancer development. OCA has been effective in treating primary biliary cholangitis (PBC), a liver disease, and is approved by the Food and Drug Administration (FDA) for use at a lower dose (10 mg). There have been studies showing that OCA decreases inflammation and fibrosis. However, it is not yet known whether OCA works on reducing the number of polyps in patients with FAP.

NCT ID: NCT05112822 Not yet recruiting - Clinical trials for Familial Adenomatous Polyposis

Testing Obeticholic Acid (OCA) for Familial Adenomatous Polyposis (FAP)

Start date: March 31, 2022
Phase: Phase 1
Study type: Interventional

This is a trial that intends to evaluate the effect of treatment with the drug obeticholic acid in the treatment of the Familial Adenomatous Polyposis condition.

NCT ID: NCT04865601 Recruiting - Colorectal Cancer Clinical Trials

DNA Adductomics for Colorectal Cancer Investigation

adductomics
Start date: February 15, 2021
Phase:
Study type: Observational

This project seeks to identify DNA-adducts in colon tissue from different groups of patients with CRC scheduled for complete or partial colon resections. Other patients scheduled for resection of the colon serve as controls. In addition, surrogate samples such as white blood cells are investigated for the presense of adducts while blood plasma and urine are investigated for the presense of DNA-repair products.

NCT ID: NCT04709445 Recruiting - Ulcerative Colitis Clinical Trials

Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of upper GI, lower GI and hepatobiliary surgery with anastomosis formation in open or laparoscopic surgery. Postoperatively, a detailed software-based assessment of each recording is performed to determine the objective ICG-NIRF perfusion rate before and after anastomosis formation, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak.