Primary Investigator:Bryson Katona, MD, PhD
Research Coordinator: Julie Starr
A Study of Guselkumab in Participants With Familial Adenomatous Polyposis
The purpose of this study is to see if guselkomab (Tremfya) is useful for treating patients with familial adenomatous polyposis. The safety and effectiveness of guselkomab will be studied.
1) Phenotypic familial adenomatous polyposis (FAP) with disease involvement of the colorectal by either genetic or clinical diagnosis: Adenomatous polyposis coli (APC) germline mutation with or without family history, or with greater than 100 adenomas in large intestine and a family history of FAP, attenuated FAP is allowed. FAP phenotype post colectomy for polyposis with a family history of FAP may be allowed.
2) Post-Colectomy or subtotal colectomy
3) Polyps with a sum of diameters greater than or equal to 10 millimeter (mm) in the rectum or pouch on biopsy at screening.
4) A woman of childbearing potential must agree not to get pregnant during the study and at least 12 weeks after the last dose of study administration.
5) A woman must agree not to breast feed or donate eggs (ova, oocytes) during the study and for a period of 12 weeks after the last dose of study administration.
1) Prior use of any biologic therapy targeting interleukin (IL)-12/23, IL-17, or IL-23 receptor
2) Use of a non-steroidal anti-inflammatory drugs other than aspirin during the study. The use 81 milligram (mg) of aspirin a day or 650 mg of aspirin per week is allowed.
3) Treatment with other FAP-directed drug therapy (including NSAID [Nonsteroidal anti-inflammatory drug] drugs), unless completes a 4-week washout period prior to randomization.
4) Duodenum or colon/rectum/pouch with high grade dysplasia or cancer on biopsy at screening
5) Duodenal , colorectal, or pouch polyp> 1 centimeter (cm) not excised at the screening evaluation.
Preliminary Evaluation of Septin9 in Patients with Hereditary Colon Cancer Syndromes
This is an observational, case-control study evaluating the quantitative level of Septin9 in plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family members as controls and references.