Participant Population. The target population for the ESD/FPI intervention consisted of male and female youth aged 15-24, whether or not they were using a modern method of contraception at the time of enrollment. For the intervention, Pathfinder proposed to recruit about 2,500 youth. Using the sample size estimation formula described below, the estimated sample size for the study was 880 youth aged 18-24 to be drawn from the ESD/FPI-recruited intervention participants. While about 895 youth aged 18-24 were recruited for the study at baseline, only 504 of them could be reached at endline.3 Consequently, this report will be based on the data from the 504 participants surveyed at both the baseline and endline.
Participant Population. Study participants were recruited from two clinical centers as part of a larger randomized, placebo-controlled, chemoprevention clinical trial testing the efficacy of supplemental calcium and vitamin D for preventing colorectal adenoma recurrence. Eligible participants were 45-75 years old, in general good health, and within 4 months of study entry had a colonoscopy resulting in a histologically identified neoplastic polyp ≥2mm in diameter. Exclusion criteria included an invasive carcinoma in any polyp removed, familial colonic polyposis syndromes, inflammatory bowel diseases, malabsorption syndromes, history of large bowel resection, alcohol or narcotic dependence, serum calcium outside the normal range, creatinine greater than 20% over the upper limit of normal, serum 25-hydroxy vitamin D <12ng/mL or >90ng/mL, history of kidney stones or hyperparathyroidism, and history of osteoporosis or other medical condition that could require supplemental vitamin D or calcium. Additional exclusion criteria for the adjunct study included being unable to be off aspirin for 7 days, history of a bleeding disorder, or current use of an anticoagulant medication. Clinical Trial Protocol For the parent study, between May 2004 and July 2008, 19,083 apparently eligible patients were identified through initial screening of colonoscopy and pathology reports. Of these, 2,259 met the final eligibility criteria, consented to participate, and were randomized. After the initial parent study was underway, funding was received for the adjunct biomarker study. For the adjunct study, near the end of the placebo run-in period, without knowledge of treatment assignment, 231 apparently eligible parent study participants at two clinical centers (South Carolina and Georgia) were offered participation in the biomarker study. Of these, 109 met the final eligibility criteria, signed consent, and had baseline rectal biopsies taken; of these, sufficient biopsy tissue for biomarker measurements was obtained at baseline and one year follow up on 104. All participants signed a consent form upon enrollment and the Institutional Review Boards at each center approved the research. At enrollment, the coordinator collected information from each study participant on medical history, medication and nutritional supplement use, diet, and lifestyle. Diet was assessed using a semi-quantitative Block Brief 2000 food frequency questionnaire (NutritionQuest, Berkeley, CA). Blood to measure calcium, creatinine, 25...
Participant Population. Participants will be breast cancer patients with stage I-III histologically confirmed diagnosis.
