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Clinical Trials/NCT00900289
NCT00900289
Unknown
Not Applicable

DNA Methylation as a Predictor for Response and Progression-Free Survival in Patients With Ovarian Cancer

Liz-Anne Lewsley26 sites in 1 country1,000 target enrollmentMarch 2002
ConditionsOvarian Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
Liz-Anne Lewsley
Enrollment
1000
Locations
26
Primary Endpoint
Progression-free survival
Last Updated
13 years ago

Overview

Brief Summary

RATIONALE: Studying tissue and blood samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This laboratory study is evaluating DNA to see how well it predicts response to treatment in patients with stage I, stage II, stage III, or stage IV ovarian epithelial cancer.

Detailed Description

OBJECTIVES: * To determine if DNA methylation patterns and expression of differentially methylated genes taken before chemotherapy can predict patient outcome with regard to progression-free survival. * To evaluate whether DNA methylation can predict response assessed by RECIST criteria and CA 125 response. * To evaluate the specificity and sensitivity of predicting methylation changes in tumor from the changes at the corresponding CpG islands in plasma. OUTLINE: Tumor samples are collected at the time of initial laparotomy and blood is drawn prior to surgery for DNA methylation and biomarker studies. Changes in DNA methylation will be examined globally using DNA methylation hybridization to microarrays and methylation specific PCR, as well as expression of genes shown to be differentially methylated.

Registry
clinicaltrials.gov
Start Date
March 2002
End Date
TBD
Last Updated
13 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Liz-Anne Lewsley
Responsible Party
Sponsor Investigator
Principal Investigator

Liz-Anne Lewsley

Project Manager

Cancer Research UK, Glasgow

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Progression-free survival

Time Frame: Ongoing

To determine if DNA methylation patterns and expression differentially methylated genes taken before chemotherapy can predict patient outcome with regard to progression-free survival.

Secondary Outcomes

  • Response(ongoing)
  • Methylation changes in tumour(Ongoing)

Study Sites (26)

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