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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00900289
• Other study ID #: CDR0000577616
• Secondary ID: SCOTTISH-DNA-MET
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: February 12, 2013
• Start date: March 2002

Study information

• Verified date: February 2013
• Source: Cancer Research UK, Glasgow
• Contact: Liz-Anne Lewsley
• Phone: 0141 301 7193
• Email: liz-anne.lewsley[@]glasgow.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Genetic:
• DNA methylation analysis

• microarray analysis

• polymerase chain reaction

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	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	Ninewells Hospital	Dundee	Scotland
United Kingdom	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland
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	Barts and the London NHS Trust	London	England
United Kingdom	Hammersmith Hospital	London	England
United Kingdom	Mid Kent Oncology Centre at Maidstone Hospital	Maidstone	England
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Milton Keynes General Hospital	Milton Keynes	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Dorset Cancer Centre	Poole Dorset	England
United Kingdom	Stirling Royal Infirmary	Stirling	England
United Kingdom	Taunton and Somerset Hospital	Taunton Somerset	England
United Kingdom	Royal Cornwall Hospital	Truro, Cornwall	England
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England

Sponsors (1)

Lead Sponsor	Collaborator
Liz-Anne Lewsley

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	To determine if DNA methylation patterns and expression differentially methylated genes taken before chemotherapy can predict patient outcome with regard to progression-free survival.	Ongoing	No
Secondary	Response	To evaluate whether DNA methylation can predict response.	ongoing	No
Secondary	Methylation changes in tumour	To evaluate the specificity and sensitivity of predicting methylation changes in tumour from the changes at the corresponding CpG islands in plasma	Ongoing	No