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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Cancer Research UK, Glasgow
Sponsor:
Information provided by (Responsible Party):
Liz-Anne Lewsley, Cancer Research UK, Glasgow
ClinicalTrials.gov Identifier:
NCT00900289
First received: May 9, 2009
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Ovarian Cancer
Genetic: DNA methylation analysis
Genetic: microarray analysis
Genetic: polymerase chain reaction
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: DNA Methylation as a Predictor for Response and Progression-Free Survival in Patients With Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Cancer Research UK, Glasgow:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
    To determine if DNA methylation patterns and expression differentially methylated genes taken before chemotherapy can predict patient outcome with regard to progression-free survival.


Secondary Outcome Measures:
  • Response [ Time Frame: ongoing ] [ Designated as safety issue: No ]
    To evaluate whether DNA methylation can predict response.

  • Methylation changes in tumour [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
    To evaluate the specificity and sensitivity of predicting methylation changes in tumour from the changes at the corresponding CpG islands in plasma


Biospecimen Retention:   Samples With DNA

Tissue and whole blood


Estimated Enrollment: 1000
Study Start Date: March 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients eligible for this study will be patients with clinically suspected FIGO stages Ic-IV epithelial ovarian cancer that are about to undergo surgery for confirmatory biopsy and attempted cytoreductive surgery.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900289

Contacts
Contact: Liz-Anne Lewsley 0141 301 7193 liz-anne.lewsley@glasgow.ac.uk

Locations
United Kingdom
Basildon University Hospital Recruiting
Basildon, England, United Kingdom, SS16 5NL
Contact: Contact Person    44-1268-533-911      
St. Michael's Hospital Recruiting
Bristol, England, United Kingdom, BS2 8EG
Contact: John Murdoch    117-928-5810    john.murdoch@ubht.swest.nhs.uk   
Queens Hospital Recruiting
Burton-upon-Trent, England, United Kingdom, DE13 0RB
Contact: Mojca Persic    44-1283-566-333    mojca.persic@derbyhospitals.nhs.uk   
Gloucestershire Oncology Centre at Cheltenham General Hospital Recruiting
Cheltenham, England, United Kingdom, GL53 7AN
Contact: Robert Gornall, MD    44-8454-224-331      
Essex County Hospital Recruiting
Colchester, England, United Kingdom, C03 3NB
Contact: Alan Lamont, MD    44-1206-744-582    alan.lamont@essexrivers.nhs.uk   
Derbyshire Royal Infirmary Recruiting
Derby, England, United Kingdom, DE1 2QY
Contact: Anish Bali, MD    44-1332-785-088      
Gloucestershire Royal Hospital Recruiting
Gloucester, England, United Kingdom, GL1 3NN
Contact: Robert Gornall, MD    44-8454-222-222      
Hereford Hospitals Recruiting
Hereford, England, United Kingdom, HR1 2ER
Contact: Contact Person    44-1432-355-444      
Princess Royal Hospital at Hull and East Yorkshire NHS Trust Recruiting
Hull, England, United Kingdom, HU8 9HE
Contact: Robert Dealy    44-1482-701-151      
Ipswich Hospital Recruiting
Ipswich, England, United Kingdom, IP4 5PD
Contact: Anders Linder, MD    44-1473-712-233    anders.linder@ipswichhospital.nhs.uk   
Barts and the London NHS Trust Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Contact Person    44-20-7377-7000      
Hammersmith Hospital Recruiting
London, England, United Kingdom, W12 OHS
Contact: Hani Gabra, MD    44-20-8383-4661    h.gabra@imperial.ac.uk   
Mid Kent Oncology Centre at Maidstone Hospital Recruiting
Maidstone, England, United Kingdom, ME16 9QQ
Contact: Jeff Summers    44-1622-729-000      
James Cook University Hospital Recruiting
Middlesbrough, England, United Kingdom, TS4 3BW
Contact: Derek Cruickshank    44-1642-850-850      
Milton Keynes General Hospital Recruiting
Milton Keynes, England, United Kingdom, MK6 5LD
Contact: Christopher B. Lynch, MD, FRCS, FRCOG    44-1908-243-218      
Norfolk and Norwich University Hospital Recruiting
Norwich, England, United Kingdom, NR4 7UY
Contact: J. Nieto, MD    44-1603-288-692      
Derriford Hospital Recruiting
Plymouth, England, United Kingdom, PL6 8DH
Contact: Anthony Falconer, MD    44-175-277-7111      
Dorset Cancer Centre Recruiting
Poole Dorset, England, United Kingdom, BH15 2JB
Contact: Richard Osborne, MD, FRCP    44-1-202-448-265      
Stirling Royal Infirmary Recruiting
Stirling, England, United Kingdom, FK8 2AU
Contact: John D. Steven, MD    44-1786-434-000    john.steven@fvah.scot.nhs.uk   
Taunton and Somerset Hospital Recruiting
Taunton Somerset, England, United Kingdom, TA1 5DA
Contact: Orla McNally, MD    44-1823-342-562      
Royal Cornwall Hospital Recruiting
Truro, Cornwall, England, United Kingdom, TR1 3LJ
Contact: Contact Person    44-1872-250-000      
Southend University Hospital NHS Foundation Trust Recruiting
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Contact: Contact Person    44-1702-435-555      
Aberdeen Royal Infirmary Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Contact: David Parkin    44-1224-553-468      
Ninewells Hospital Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Contact: Michelle Ferguson, MD    44-1382-660-111    michelle.ferguson@nhs.net   
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XR
Contact: John F. Smyth, MD    44-131-777-3512      
Royal Infirmary - Castle Recruiting
Glasgow, Scotland, United Kingdom, G4 0SF
Contact: Nadeem Siddiqui, MD    44-141-201-0857      
Sponsors and Collaborators
Liz-Anne Lewsley
Investigators
Principal Investigator: Nadeem Siddiqui, MD Scottish Gynaecological Cancer Trials Group
  More Information

Additional Information:
No publications provided

Responsible Party: Liz-Anne Lewsley, Project Manager, Cancer Research UK, Glasgow
ClinicalTrials.gov Identifier: NCT00900289     History of Changes
Other Study ID Numbers: CDR0000577616, SCOTTISH-DNA-METHYLATION, EU-20793
Study First Received: May 9, 2009
Last Updated: February 12, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Cancer Research UK, Glasgow:
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 19, 2014