NCT02656134 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Campos FG, Sulbaran M, Safatle-Ribeiro AV, Martinez CA
Duodenal adenoma surveillance in patients with familial adenomatous polyposis. World J Gastrointest Endosc. 2015 Aug 10;7(10):950-9. doi: 10.4253/wjge.v7.i10.950. Review.
Groves CJ, Saunders BP, Spigelman AD, Phillips RK
Duodenal cancer in patients with familial adenomatous polyposis (FAP): results of a 10 year prospective study. Gut. 2002 May;50(5):636-41.
Mathus-Vliegen EM, Boparai KS, Dekker E, van Geloven N
Progression of duodenal adenomatosis in familial adenomatous polyposis: due to ageing of subjects and advances in technology. Fam Cancer. 2011 Sep;10(3):491-9. doi: 10.1007/s10689-011-9433-2.
Spigelman AD, Talbot IC, Penna C, Nugent KP, Phillips RK, Costello C, DeCosse JJ
Evidence for adenoma-carcinoma sequence in the duodenum of patients with familial adenomatous polyposis. The Leeds Castle Polyposis Group (Upper Gastrointestinal Committee). J Clin Pathol. 1994 Aug;47(8):709-10.

Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis: A Prospective Clinical, Immunopathologic and Molecular Analysis

Clinical trial NCT02656134 - References