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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00900289

Enrollment

1000

Registered

2009-05-12

Start date

2002-03-31

Completion date

Unknown

Last updated

2013-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

stage IC ovarian epithelial cancer, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer

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.

Interventions

GENETICDNA methylation analysis

GENETICmicroarray analysis

GENETICpolymerase chain reaction

OTHERimmunohistochemistry staining method

OTHERlaboratory biomarker analysis

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United Kingdom

Contacts

Primary ContactLiz-Anne Lewsley

liz-anne.lewsley@glasgow.ac.uk0141 301 7193

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026