Surrogate endpoint biomarker assays in phase II chemoprevention clinical trials Conference Paper
| Authors: | Lipkin, M.; Bhandari, M.; Hakissian, M.; Croll, W.; Wong, G. |
| Title: | Surrogate endpoint biomarker assays in phase II chemoprevention clinical trials |
| Conference Title: | Quantitative Pathology in Chemoprevention Trials: Standardization and Quality Control of Surrogate Endpoint Biomarker Assays for Colon, Breast, and Prostate |
| Abstract: | Surrogate endpoint biomarker (SEB) assays carried out in rodent models have benefitted from large amounts of available colonic tissue, abundant well-aligned colonic crypts, and population groups with fairly uniform biological characteristics. In contrast, SEB assays in human colon studies have often been carried out on small groups of subjects, without the advantages inherent in rodent studies. Some factors that contribute to variations in human colon SEB assays include differences in genetic background, the extent and duration of previous colonic diseases, degree of previous chronic irritation to the colonic mucosa, the initial levels of nutrients ingested prior to the study, administration of large volumes of fluid prior to SEB measurement which induce hypermetabolic and then quiescent changes in the mucosa, failure to use strict morphologic criteria in counting colonic crypts, and availability of only a small number of crypts for analysis. Measurements of adenoma recurrence over short durations are limited by factors that include a large potential miss-rate of small adenomas, a window of observation with short duration which limits the stage of adenoma observed, and the consequent inability to measure mechanisms that a chemopreventive intervention is affecting in a different stage of adenoma development. |
| Keywords: | clinical trial; review; nonhuman; conference paper; antineoplastic agent; biomarkers; biological marker; biological markers; animal; cell division; cancer prevention; chemoprophylaxis; phase 2 clinical trial; observer variation; animal model; colonic neoplasms; calcium; cell differentiation; drug effect; pathology; diet supplementation; animalia; colon cancer; colon tumor; anticarcinogenic agents; vitamin d; rat; rats; rodentia; colon disease; colon; intestine mucosa; chemoprevention; intestinal mucosa; colonic diseases; clinical trials, phase ii; human; male; female; priority journal |
| Journal Title | Journal of Cellular Biochemistry |
| Issue: | Suppl. 19 |
| Conference Dates: | 1994 Feb 9-13 |
| Conference Location: | San Diego, CA |
| ISBN: | 0730-2312 |
| Publisher: | John Wiley & Sons |
| Date Published: | 1994-01-01 |
| Start Page: | 47 |
| End Page: | 54 |
| Language: | English |
| PUBMED: | 7823605 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Conference Paper -- Export Date: 14 January 2019 -- Source: Scopus |
