Studying DNA in Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer

• Conditions: Ovarian Cancer

• Registration Number: NCT00900289
• Lead Sponsor: Liz-Anne Lewsley

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.

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	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 Outcome Measures

Name	Time	Method
Response	ongoing	To evaluate whether DNA methylation can predict response.
Methylation changes in tumour	Ongoing	To evaluate the specificity and sensitivity of predicting methylation changes in tumour from the changes at the corresponding CpG islands in plasma

Trial Locations

Locations (26)

Basildon University Hospital; 🇬🇧 Basildon, England, United Kingdom

St. Michael's Hospital; 🇬🇧 Bristol, England, United Kingdom

Queens Hospital; 🇬🇧 Burton-upon-Trent, England, United Kingdom

Gloucestershire Oncology Centre at Cheltenham General Hospital; 🇬🇧 Cheltenham, England, United Kingdom

Essex County Hospital; 🇬🇧 Colchester, England, United Kingdom

Derbyshire Royal Infirmary; 🇬🇧 Derby, England, United Kingdom

Gloucestershire Royal Hospital; 🇬🇧 Gloucester, England, United Kingdom

Hereford Hospitals; 🇬🇧 Hereford, England, United Kingdom

Princess Royal Hospital at Hull and East Yorkshire NHS Trust; 🇬🇧 Hull, England, United Kingdom

Ipswich Hospital; 🇬🇧 Ipswich, England, United Kingdom

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