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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Cancer Research UK, Glasgow.
Recruitment status was:  Recruiting
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   (Adult, Senior)
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

Locations
United Kingdom
Basildon University Hospital
Basildon, England, United Kingdom, SS16 5NL
St. Michael's Hospital
Bristol, England, United Kingdom, BS2 8EG
Queens Hospital
Burton-upon-Trent, England, United Kingdom, DE13 0RB
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Essex County Hospital
Colchester, England, United Kingdom, C03 3NB
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom, GL1 3NN
Hereford Hospitals
Hereford, England, United Kingdom, HR1 2ER
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom, HU8 9HE
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
Barts and the London NHS Trust
London, England, United Kingdom, EC1A 7BE
Hammersmith Hospital
London, England, United Kingdom, W12 OHS
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
James Cook University Hospital
Middlesbrough, England, United Kingdom, TS4 3BW
Milton Keynes General Hospital
Milton Keynes, England, United Kingdom, MK6 5LD
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom, NR4 7UY
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Dorset Cancer Centre
Poole Dorset, England, United Kingdom, BH15 2JB
Stirling Royal Infirmary
Stirling, England, United Kingdom, FK8 2AU
Taunton and Somerset Hospital
Taunton Somerset, England, United Kingdom, TA1 5DA
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom, TR1 3LJ
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XR
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom, G4 0SF
Sponsors and Collaborators
Liz-Anne Lewsley
Investigators
Principal Investigator: Nadeem Siddiqui, MD Scottish Gynaecological Cancer Trials Group
  More Information

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
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on December 02, 2016