Limits of detection of chemopreventive efficacy: Karyometry of skin biopsies

Peter H. Bartels, Michael L. Yozwiak, Hubert G. Bartels, Yun Liu, Lisa M. Hess, David S Alberts

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objective: This study was designed to establish estimates of the smallest effects due to chemopreventive intervention detectable by karyometry in skin biopsies. Methods: Estimates of the smallest change of statistical significance and estimates of the power of the test were derived for several key features descriptive of the distribution of nuclear chromatin. Results from triplicate biopsies from the same case were used to provide estimates of the within-case, biopsy-to-biopsy variance. Results: Generally, a change in feature value due to chemopreventive intervention can be statistically secured when it amounts to 5% to 10%. In clinical trials where matched baseline and end of study biopsies from the same cases are available, paired comparison ANOVA can detect a 2% change on samples of 25 cases. Establishing efficacy in individual cases requires a change in feature values on the order of 10% to 15%. Conclusions: Karyometry provides a sensitive, quantitative method for the assessment of efficacy of chemoprevention. The effects of within-case, biopsy-to-biopsy variance need to be considered only in the evaluation of individual cases and are on the order of 5% in skin biopsies.

Original languageEnglish (US)
Pages (from-to)1689-1695
Number of pages7
JournalCancer Epidemiology Biomarkers and Prevention
Volume17
Issue number7
DOIs
StatePublished - Jul 2008

Fingerprint

Karyometry
Limit of Detection
Biopsy
Skin
Matched-Pair Analysis
Chemoprevention
Chromatin
Analysis of Variance
Clinical Trials

ASJC Scopus subject areas

  • Epidemiology
  • Oncology

Cite this

Limits of detection of chemopreventive efficacy : Karyometry of skin biopsies. / Bartels, Peter H.; Yozwiak, Michael L.; Bartels, Hubert G.; Liu, Yun; Hess, Lisa M.; Alberts, David S.

In: Cancer Epidemiology Biomarkers and Prevention, Vol. 17, No. 7, 07.2008, p. 1689-1695.

Research output: Contribution to journalArticle

Bartels, Peter H. ; Yozwiak, Michael L. ; Bartels, Hubert G. ; Liu, Yun ; Hess, Lisa M. ; Alberts, David S. / Limits of detection of chemopreventive efficacy : Karyometry of skin biopsies. In: Cancer Epidemiology Biomarkers and Prevention. 2008 ; Vol. 17, No. 7. pp. 1689-1695.
@article{20841a2c5be74476843c38aa0d1cc065,
title = "Limits of detection of chemopreventive efficacy: Karyometry of skin biopsies",
abstract = "Objective: This study was designed to establish estimates of the smallest effects due to chemopreventive intervention detectable by karyometry in skin biopsies. Methods: Estimates of the smallest change of statistical significance and estimates of the power of the test were derived for several key features descriptive of the distribution of nuclear chromatin. Results from triplicate biopsies from the same case were used to provide estimates of the within-case, biopsy-to-biopsy variance. Results: Generally, a change in feature value due to chemopreventive intervention can be statistically secured when it amounts to 5{\%} to 10{\%}. In clinical trials where matched baseline and end of study biopsies from the same cases are available, paired comparison ANOVA can detect a 2{\%} change on samples of 25 cases. Establishing efficacy in individual cases requires a change in feature values on the order of 10{\%} to 15{\%}. Conclusions: Karyometry provides a sensitive, quantitative method for the assessment of efficacy of chemoprevention. The effects of within-case, biopsy-to-biopsy variance need to be considered only in the evaluation of individual cases and are on the order of 5{\%} in skin biopsies.",
author = "Bartels, {Peter H.} and Yozwiak, {Michael L.} and Bartels, {Hubert G.} and Yun Liu and Hess, {Lisa M.} and Alberts, {David S}",
year = "2008",
month = "7",
doi = "10.1158/1055-9965.EPI-08-0313",
language = "English (US)",
volume = "17",
pages = "1689--1695",
journal = "Cancer Epidemiology Biomarkers and Prevention",
issn = "1055-9965",
publisher = "American Association for Cancer Research Inc.",
number = "7",

}

TY - JOUR

T1 - Limits of detection of chemopreventive efficacy

T2 - Karyometry of skin biopsies

AU - Bartels, Peter H.

AU - Yozwiak, Michael L.

AU - Bartels, Hubert G.

AU - Liu, Yun

AU - Hess, Lisa M.

AU - Alberts, David S

PY - 2008/7

Y1 - 2008/7

N2 - Objective: This study was designed to establish estimates of the smallest effects due to chemopreventive intervention detectable by karyometry in skin biopsies. Methods: Estimates of the smallest change of statistical significance and estimates of the power of the test were derived for several key features descriptive of the distribution of nuclear chromatin. Results from triplicate biopsies from the same case were used to provide estimates of the within-case, biopsy-to-biopsy variance. Results: Generally, a change in feature value due to chemopreventive intervention can be statistically secured when it amounts to 5% to 10%. In clinical trials where matched baseline and end of study biopsies from the same cases are available, paired comparison ANOVA can detect a 2% change on samples of 25 cases. Establishing efficacy in individual cases requires a change in feature values on the order of 10% to 15%. Conclusions: Karyometry provides a sensitive, quantitative method for the assessment of efficacy of chemoprevention. The effects of within-case, biopsy-to-biopsy variance need to be considered only in the evaluation of individual cases and are on the order of 5% in skin biopsies.

AB - Objective: This study was designed to establish estimates of the smallest effects due to chemopreventive intervention detectable by karyometry in skin biopsies. Methods: Estimates of the smallest change of statistical significance and estimates of the power of the test were derived for several key features descriptive of the distribution of nuclear chromatin. Results from triplicate biopsies from the same case were used to provide estimates of the within-case, biopsy-to-biopsy variance. Results: Generally, a change in feature value due to chemopreventive intervention can be statistically secured when it amounts to 5% to 10%. In clinical trials where matched baseline and end of study biopsies from the same cases are available, paired comparison ANOVA can detect a 2% change on samples of 25 cases. Establishing efficacy in individual cases requires a change in feature values on the order of 10% to 15%. Conclusions: Karyometry provides a sensitive, quantitative method for the assessment of efficacy of chemoprevention. The effects of within-case, biopsy-to-biopsy variance need to be considered only in the evaluation of individual cases and are on the order of 5% in skin biopsies.

UR - http://www.scopus.com/inward/record.url?scp=53549089616&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=53549089616&partnerID=8YFLogxK

U2 - 10.1158/1055-9965.EPI-08-0313

DO - 10.1158/1055-9965.EPI-08-0313

M3 - Article

C2 - 18583468

AN - SCOPUS:53549089616

VL - 17

SP - 1689

EP - 1695

JO - Cancer Epidemiology Biomarkers and Prevention

JF - Cancer Epidemiology Biomarkers and Prevention

SN - 1055-9965

IS - 7

ER -