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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-03-31

Brief Summary

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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

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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.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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DNA methylation analysis

Intervention Type GENETIC

microarray analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

immunohistochemistry staining method

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Liz-Anne Lewsley

OTHER

Sponsor Role lead

Responsible Party

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Liz-Anne Lewsley

Project Manager

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

St. Michael's Hospital

Bristol, England, United Kingdom

Site Status RECRUITING

Queens Hospital

Burton-on-Trent, England, United Kingdom

Site Status RECRUITING

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, United Kingdom

Site Status RECRUITING

Essex County Hospital

Colchester, England, United Kingdom

Site Status RECRUITING

Derbyshire Royal Infirmary

Derby, England, United Kingdom

Site Status RECRUITING

Gloucestershire Royal Hospital

Gloucester, England, United Kingdom

Site Status RECRUITING

Hereford Hospitals

Hereford, England, United Kingdom

Site Status RECRUITING

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, United Kingdom

Site Status RECRUITING

Ipswich Hospital

Ipswich, England, United Kingdom

Site Status RECRUITING

Barts and the London NHS Trust

London, England, United Kingdom

Site Status RECRUITING

Hammersmith Hospital

London, England, United Kingdom

Site Status RECRUITING

Mid Kent Oncology Centre at Maidstone Hospital

Maidstone, England, United Kingdom

Site Status RECRUITING

James Cook University Hospital

Middlesbrough, England, United Kingdom

Site Status RECRUITING

Milton Keynes General Hospital

Milton Keynes, England, United Kingdom

Site Status RECRUITING

Norfolk and Norwich University Hospital

Norwich, England, United Kingdom

Site Status RECRUITING

Derriford Hospital

Plymouth, England, United Kingdom

Site Status RECRUITING

Dorset Cancer Centre

Poole Dorset, England, United Kingdom

Site Status RECRUITING

Stirling Royal Infirmary

Stirling, England, United Kingdom

Site Status RECRUITING

Taunton and Somerset Hospital

Taunton Somerset, England, United Kingdom

Site Status RECRUITING

Royal Cornwall Hospital

Truro, Cornwall, England, United Kingdom

Site Status RECRUITING

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, United Kingdom

Site Status RECRUITING

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom

Site Status RECRUITING

Ninewells Hospital

Dundee, Scotland, United Kingdom

Site Status RECRUITING

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, United Kingdom

Site Status RECRUITING

Royal Infirmary - Castle

Glasgow, Scotland, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Liz-Anne Lewsley

Role: CONTACT

0141 301 7193

Facility Contacts

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Contact Person

Role: primary

44-1268-533-911

John Murdoch

Role: primary

117-928-5810

Mojca Persic

Role: primary

44-1283-566-333

Robert Gornall, MD

Role: primary

44-8454-224-331

Alan Lamont, MD

Role: primary

44-1206-744-582

Anish Bali, MD

Role: primary

44-1332-785-088

Robert Gornall, MD

Role: primary

44-8454-222-222

Contact Person

Role: primary

44-1432-355-444

Robert Dealy

Role: primary

44-1482-701-151

Anders Linder, MD

Role: primary

44-1473-712-233

Contact Person

Role: primary

44-20-7377-7000

Hani Gabra, MD

Role: primary

44-20-8383-4661

Jeff Summers

Role: primary

44-1622-729-000

Derek Cruickshank

Role: primary

44-1642-850-850

Christopher B. Lynch, MD, FRCS, FRCOG

Role: primary

44-1908-243-218

J. Nieto, MD

Role: primary

44-1603-288-692

Anthony Falconer, MD

Role: primary

44-175-277-7111

Richard Osborne, MD, FRCP

Role: primary

44-1-202-448-265

John D. Steven, MD

Role: primary

44-1786-434-000

Orla McNally, MD

Role: primary

44-1823-342-562

Contact Person

Role: primary

44-1872-250-000

Contact Person

Role: primary

44-1702-435-555

David Parkin

Role: primary

44-1224-553-468

Michelle Ferguson, MD

Role: primary

44-1382-660-111

John F. Smyth, MD

Role: primary

44-131-777-3512

Nadeem Siddiqui, MD

Role: primary

44-141-201-0857

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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