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

February 12, 2013 updated by: Liz-Anne Lewsley

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

Unknown

Conditions

Ovarian Cancer

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Liz-Anne Lewsley

Investigators

Principal Investigator: Nadeem Siddiqui, MD, Scottish Gynaecological Cancer Trials Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria