- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00900289
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
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Liz-Anne Lewsley
- Phone Number: 0141 301 7193
- Email: liz-anne.lewsley@glasgow.ac.uk
Study Locations
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England
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Basildon, England, United Kingdom, SS16 5NL
- Recruiting
- Basildon University Hospital
-
Contact:
- Contact Person
- Phone Number: 44-1268-533-911
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Bristol, England, United Kingdom, BS2 8EG
- Recruiting
- St. Michael's Hospital
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Contact:
- John Murdoch
- Phone Number: 117-928-5810
- Email: john.murdoch@ubht.swest.nhs.uk
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Burton-upon-Trent, England, United Kingdom, DE13 0RB
- Recruiting
- Queens Hospital
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Cheltenham, England, United Kingdom, GL53 7AN
- Recruiting
- Gloucestershire Oncology Centre at Cheltenham General Hospital
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Contact:
- Robert Gornall, MD
- Phone Number: 44-8454-224-331
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Colchester, England, United Kingdom, C03 3NB
- Recruiting
- Essex County Hospital
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Contact:
- Alan Lamont, MD
- Phone Number: 44-1206-744-582
- Email: alan.lamont@essexrivers.nhs.uk
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Derby, England, United Kingdom, DE1 2QY
- Recruiting
- Derbyshire Royal Infirmary
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Contact:
- Anish Bali, MD
- Phone Number: 44-1332-785-088
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Gloucester, England, United Kingdom, GL1 3NN
- Recruiting
- Gloucestershire Royal Hospital
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Contact:
- Robert Gornall, MD
- Phone Number: 44-8454-222-222
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Hereford, England, United Kingdom, HR1 2ER
- Recruiting
- Hereford Hospitals
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Contact:
- Contact Person
- Phone Number: 44-1432-355-444
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Hull, England, United Kingdom, HU8 9HE
- Recruiting
- Princess Royal Hospital at Hull and East Yorkshire NHS Trust
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Contact:
- Robert Dealy
- Phone Number: 44-1482-701-151
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Ipswich, England, United Kingdom, IP4 5PD
- Recruiting
- Ipswich Hospital
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Contact:
- Anders Linder, MD
- Phone Number: 44-1473-712-233
- Email: anders.linder@ipswichhospital.nhs.uk
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London, England, United Kingdom, EC1A 7BE
- Recruiting
- Barts and the London NHS Trust
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Contact:
- Contact Person
- Phone Number: 44-20-7377-7000
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London, England, United Kingdom, W12 OHS
- Recruiting
- Hammersmith Hospital
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Contact:
- Hani Gabra, MD
- Phone Number: 44-20-8383-4661
- Email: h.gabra@imperial.ac.uk
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Maidstone, England, United Kingdom, ME16 9QQ
- Recruiting
- Mid Kent Oncology Centre at Maidstone Hospital
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Contact:
- Jeff Summers
- Phone Number: 44-1622-729-000
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Middlesbrough, England, United Kingdom, TS4 3BW
- Recruiting
- James Cook University Hospital
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Contact:
- Derek Cruickshank
- Phone Number: 44-1642-850-850
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Milton Keynes, England, United Kingdom, MK6 5LD
- Recruiting
- Milton Keynes General Hospital
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Contact:
- Christopher B. Lynch, MD, FRCS, FRCOG
- Phone Number: 44-1908-243-218
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Norwich, England, United Kingdom, NR4 7UY
- Recruiting
- Norfolk and Norwich University Hospital
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Contact:
- J. Nieto, MD
- Phone Number: 44-1603-288-692
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Plymouth, England, United Kingdom, PL6 8DH
- Recruiting
- Derriford Hospital
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Contact:
- Anthony Falconer, MD
- Phone Number: 44-175-277-7111
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Poole Dorset, England, United Kingdom, BH15 2JB
- Recruiting
- Dorset Cancer Centre
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Contact:
- Richard Osborne, MD, FRCP
- Phone Number: 44-1-202-448-265
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Stirling, England, United Kingdom, FK8 2AU
- Recruiting
- Stirling Royal Infirmary
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Contact:
- John D. Steven, MD
- Phone Number: 44-1786-434-000
- Email: john.steven@fvah.scot.nhs.uk
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Taunton Somerset, England, United Kingdom, TA1 5DA
- Recruiting
- Taunton and Somerset Hospital
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Contact:
- Orla McNally, MD
- Phone Number: 44-1823-342-562
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Truro, Cornwall, England, United Kingdom, TR1 3LJ
- Recruiting
- Royal Cornwall Hospital
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Contact:
- Contact Person
- Phone Number: 44-1872-250-000
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Westcliff-On-Sea, England, United Kingdom, SS0 0RY
- Recruiting
- Southend University Hospital NHS Foundation Trust
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Contact:
- Contact Person
- Phone Number: 44-1702-435-555
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Scotland
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Aberdeen, Scotland, United Kingdom, AB25 2ZN
- Recruiting
- Aberdeen Royal Infirmary
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Contact:
- David Parkin
- Phone Number: 44-1224-553-468
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Dundee, Scotland, United Kingdom, DD1 9SY
- Recruiting
- Ninewells Hospital
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Contact:
- Michelle Ferguson, MD
- Phone Number: 44-1382-660-111
- Email: michelle.ferguson@nhs.net
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Edinburgh, Scotland, United Kingdom, EH4 2XR
- Recruiting
- Edinburgh Cancer Centre at Western General Hospital
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Contact:
- John F. Smyth, MD
- Phone Number: 44-131-777-3512
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Glasgow, Scotland, United Kingdom, G4 0SF
- Recruiting
- Royal Infirmary - Castle
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Contact:
- Nadeem Siddiqui, MD
- Phone Number: 44-141-201-0857
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- Clinically suspected FIGO stages Ic-IV epithelial ovarian cancer that are about to undergo surgery for confirmatory biopsy and attempted cytoreductive surgery
- Given written informed consent
- Female and >18 years of age
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 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.
|
Ongoing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response
Time Frame: ongoing
|
To evaluate whether DNA methylation can predict response.
|
ongoing
|
Methylation changes in tumour
Time Frame: Ongoing
|
To evaluate the specificity and sensitivity of predicting methylation changes in tumour from the changes at the corresponding CpG islands in plasma
|
Ongoing
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nadeem Siddiqui, MD, Scottish Gynaecological Cancer Trials Group
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- CDR0000577616
- SCOTTISH-DNA-METHYLATION (Other Identifier: G75)
- EU-20793 (Other Identifier: EU)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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