NIH GUIDE, Volume 23, Number 12, March 25, 1994



National Cancer Institute

The National Cancer Institute (NCI) announces the establishment of a

biomarker registry comprised of information that may be useful to

investigators when biomarkers are being considered as intermediate

endpoints or as outcome measures in prevention trials.  In an effort

to collect information on biomarkers, the NCI seeks cooperation from

the extramural scientific community on a voluntary basis.

Information may be submitted by anyone currently engaged in biomarker


The following characteristics of biomarkers are of interest:

1.  Biological Characteristics:  The description should include, but

is not limited to, the spontaneous biological rate of progression

and/or regression, site-specificity, histology, chromosomal

aberrations, epigenetic changes, mutations, histologic correlation,

and the phase, i.e., whether the marker in question occurs at an

early, intermediate, or late stage of the carcinogenesis process.

2.  Outcome Association:  Provide information on population,

subjects, sites, intermediate endpoints, and the rate of regression

of intermediate endpoints in a given time frame in response to the

intervention (e.g., 50 percent regression in two months).  In the

case of chemoprevention trials, also provide the name of the

chemopreventive agent, dose (including toxicity data), preclinical

efficacy, preclinical safety, clinical safety, and the clinical

efficacy, if known.

3.  Epidemiological Characteristics:  Provide information on (1)

types of marker:  (a) biomarkers of susceptibility, (b) biomarkers of

exposure, (c) biomarkers of biological effects, (d) biomarkers of

disease cancer; (2) source of variability:  sampling variability,

inter- and intra-individual variability, inter- and intra-

observational variability, and time-dependent variability; (3) study

design:  case-control, prospective cohort, or randomized trial.

Provide the material for the choice of the endpoint and sample size

in your study.


For further information, contact

Barnett S. Kramer or Sudhir Srivastava

Division of Cancer Prevention and Control

National Cancer Institute

Executive Plaza North, Room 305

Bethesda, MD  20892

Telephone:  (301) 496-8544

FAX:  (301) 496-8667


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