Studying DNA in Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer
NCT ID: NCT00900289
Last Updated: 2013-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2002-03-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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DNA methylation analysis
microarray analysis
polymerase chain reaction
immunohistochemistry staining method
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
2. Given written informed consent
3. Female and \>18 years of age
18 Years
FEMALE
No
Sponsors
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Liz-Anne Lewsley
OTHER
Responsible Party
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Liz-Anne Lewsley
Project Manager
Principal Investigators
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Nadeem Siddiqui, MD
Role: PRINCIPAL_INVESTIGATOR
Scottish Gynaecological Cancer Trials Group
Locations
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Basildon University Hospital
Basildon, England, United Kingdom
St. Michael's Hospital
Bristol, England, United Kingdom
Queens Hospital
Burton-on-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
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, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, 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
Countries
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Central Contacts
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Facility Contacts
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Contact Person
Role: primary
Robert Gornall, MD
Role: primary
Anish Bali, MD
Role: primary
Robert Gornall, MD
Role: primary
Contact Person
Role: primary
Robert Dealy
Role: primary
Contact Person
Role: primary
Jeff Summers
Role: primary
Derek Cruickshank
Role: primary
Christopher B. Lynch, MD, FRCS, FRCOG
Role: primary
J. Nieto, MD
Role: primary
Anthony Falconer, MD
Role: primary
Richard Osborne, MD, FRCP
Role: primary
Orla McNally, MD
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
David Parkin
Role: primary
John F. Smyth, MD
Role: primary
Nadeem Siddiqui, MD
Role: primary
Other Identifiers
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SCOTTISH-DNA-METHYLATION
Identifier Type: OTHER
Identifier Source: secondary_id
EU-20793
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000577616
Identifier Type: -
Identifier Source: org_study_id
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