Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVE: I. Percent change in number of rectal aberrant cryptic foci (ACF) as measured by magnification chromoendoscopy SECONDARY OBJECTIVES: I. Screening for possible phase III testing II. Effects on proliferation (Ki67 expression) and apoptosis (caspase-3 expression) as measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment III. Correlation of endoscopic features with histologic characteristics of rectal ACF IV. Observation of the natural history of rectal ACF in patients receiving placebo V. Adverse events VI. Utilization of a biospecimen repository archive OUTLINE: This is a multicenter, prospective, randomized, partially blinded, placebo-controlled study. Patients are stratified according to history of prior surgical resection of the colon (yes vs no) and number of rectal aberrant cryptic foci (ACF) (5-9 vs \>= 10). Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive oral atorvastatin calcium once daily. ARM II: Patients receive oral sulindac twice daily. ARM III (blinded arm): Patients receive oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily. ARM IV (blinded arm): Patients receive an oral placebo twice daily. In all arms, treatment continues for 6 months in the absence of unacceptable toxicity. Tissue samples are collected at baseline and at the completion of study treatment. Tissue is examined by immunohistochemistry for proliferation (Ki67) and apoptosis (cleaved caspase-3). After completion of study treatment, patients are followed at approximately 30 days.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
