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

Liz-Anne Lewsley

Status: Unknown

Conditions: Ovarian Cancer

Treatments: Other: immunohistochemistry staining method; Genetic: DNA methylation analysis; Other: laboratory biomarker analysis; Genetic: polymerase chain reaction; Genetic: microarray analysis

Study type: Observational

Funder types: Other

Identifiers

NCT00900289

SCOTTISH-DNA-METHYLATION (Other Identifier)

EU-20793 (Other Identifier)

CDR0000577616

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Clinically suspected FIGO stages Ic-IV epithelial ovarian cancer that are about to undergo surgery for confirmatory biopsy and attempted cytoreductive surgery
2. Given written informed consent
3. Female and >18 years of age