Studying DNA in Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer
Conditions
Ovarian Cancer
Conditions: official terms
Neoplasms, Glandular and Epithelial - Ovarian Neoplasms
Conditions: 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
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: DNA methylation analysis Type: Genetic
Name: microarray analysis Type: Genetic
Name: polymerase chain reaction Type: Genetic
Name: immunohistochemistry staining method Type: Other
Name: laboratory biomarker analysis Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Locations
Basildon University Hospital
Basildon, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1268-533-911
St. Michael's Hospital
Bristol, England, United Kingdom
Status: Recruiting
Contact: John Murdoch - 117-928-5810 - john.murdoch@ubht.swest.nhs.uk
Queens Hospital
Burton-upon-Trent, England, United Kingdom
Status: Recruiting
Contact: Mojca Persic - 44-1283-566-333 - mojca.persic@derbyhospitals.nhs.uk
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Status: Recruiting
Contact: Robert Gornall, MD - 44-8454-224-331
Essex County Hospital
Colchester, England, United Kingdom
Status: Recruiting
Contact: Alan Lamont, MD - 44-1206-744-582 - alan.lamont@essexrivers.nhs.uk
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Status: Recruiting
Contact: Anish Bali, MD - 44-1332-785-088
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom
Status: Recruiting
Contact: Robert Gornall, MD - 44-8454-222-222
Hereford Hospitals
Hereford, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1432-355-444
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom
Status: Recruiting
Contact: Robert Dealy - 44-1482-701-151
Ipswich Hospital
Ipswich, England, United Kingdom
Status: Recruiting
Contact: Anders Linder, MD - 44-1473-712-233 - anders.linder@ipswichhospital.nhs.uk
Barts and the London NHS Trust
London, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-20-7377-7000
Hammersmith Hospital
London, England, United Kingdom
Status: Recruiting
Contact: Hani Gabra, MD - 44-20-8383-4661 - h.gabra@imperial.ac.uk
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom
Status: Recruiting
Contact: Jeff Summers - 44-1622-729-000
James Cook University Hospital
Middlesbrough, England, United Kingdom
Status: Recruiting
Contact: Derek Cruickshank - 44-1642-850-850
Milton Keynes General Hospital
Milton Keynes, England, United Kingdom
Status: Recruiting
Contact: Christopher B. Lynch, MD, FRCS, FRCOG - 44-1908-243-218
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Status: Recruiting
Contact: J. Nieto, MD - 44-1603-288-692
Derriford Hospital
Plymouth, England, United Kingdom
Status: Recruiting
Contact: Anthony Falconer, MD - 44-175-277-7111
Dorset Cancer Centre
Poole Dorset, England, United Kingdom
Status: Recruiting
Contact: Richard Osborne, MD, FRCP - 44-1-202-448-265
Stirling Royal Infirmary
Stirling, England, United Kingdom
Status: Recruiting
Contact: John D. Steven, MD - 44-1786-434-000 - john.steven@fvah.scot.nhs.uk
Taunton and Somerset Hospital
Taunton Somerset, England, United Kingdom
Status: Recruiting
Contact: Orla McNally, MD - 44-1823-342-562
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1872-250-000
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1702-435-555
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Status: Recruiting
Contact: David Parkin - 44-1224-553-468
Ninewells Hospital
Dundee, Scotland, United Kingdom
Status: Recruiting
Contact: Michelle Ferguson, MD - 44-1382-660-111 - michelle.ferguson@nhs.net
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Status: Recruiting
Contact: John F. Smyth, MD - 44-131-777-3512
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom
Status: Recruiting
Contact: Nadeem Siddiqui, MD - 44-141-201-0857
Start Date
March 2002
Sponsors
Liz-Anne Lewsley
Source
Cancer Research UK, Glasgow
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page