Ovarian CancerNCT00900289
Studying DNA in Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer
An observational study of Ovarian Cancer, run by Liz-Anne Lewsley at 26 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- DNA methylation analysis, microarray analysis and polymerase chain reaction
- How many people
- 1,000 participants
- Where
- 26 sitesUnited Kingdom
- Study dates
- Mar 2002to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United Kingdom26 sites, 26 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
David Parkin, 44-1224-553-468
- Recruiting
Basildon University Hospital
Basildon, England, SS16 5NL
Contact Person, 44-1268-533-911
- Recruiting
St. Michael's Hospital
Bristol, England, BS2 8EG
John Murdoch, 117-928-5810, john.murdoch@ubht.swest.nhs.uk
- Recruiting
Queens Hospital
Burton-on-Trent, England, DE13 0RB
Mojca Persic, 44-1283-566-333, mojca.persic@derbyhospitals.nhs.uk
- Recruiting
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Robert Gornall, MD, 44-8454-224-331
- Recruiting
Essex County Hospital
Colchester, England, C03 3NB
Alan Lamont, MD, 44-1206-744-582, alan.lamont@essexrivers.nhs.uk
- Recruiting
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Anish Bali, MD, 44-1332-785-088
- Recruiting
Ninewells Hospital
Dundee, Scotland, DD1 9SY
Michelle Ferguson, MD, 44-1382-660-111, michelle.ferguson@nhs.net
- Recruiting
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XR
John F. Smyth, MD, 44-131-777-3512
- Recruiting
Royal Infirmary - Castle
Glasgow, Scotland, G4 0SF
Nadeem Siddiqui, MD, 44-141-201-0857
- Recruiting
Gloucestershire Royal Hospital
Gloucester, England, GL1 3NN
Robert Gornall, MD, 44-8454-222-222
- Recruiting
Hereford Hospitals
Hereford, England, HR1 2ER
Contact Person, 44-1432-355-444
- Recruiting
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, HU8 9HE
Robert Dealy, 44-1482-701-151
- Recruiting
Ipswich Hospital
Ipswich, England, IP4 5PD
Anders Linder, MD, 44-1473-712-233, anders.linder@ipswichhospital.nhs.uk
- Recruiting
Barts and the London NHS Trust
London, England, EC1A 7BE
Contact Person, 44-20-7377-7000
- Recruiting
Hammersmith Hospital
London, England, W12 OHS
Hani Gabra, MD, 44-20-8383-4661, h.gabra@imperial.ac.uk
- Recruiting
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, ME16 9QQ
Jeff Summers, 44-1622-729-000
- Recruiting
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Derek Cruickshank, 44-1642-850-850
- Recruiting
Milton Keynes General Hospital
Milton Keynes, England, MK6 5LD
Christopher B. Lynch, MD, FRCS, FRCOG, 44-1908-243-218
- Recruiting
Norfolk and Norwich University Hospital
Norwich, England, NR4 7UY
J. Nieto, MD, 44-1603-288-692
- Recruiting
Derriford Hospital
Plymouth, England, PL6 8DH
Anthony Falconer, MD, 44-175-277-7111
- Recruiting
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Richard Osborne, MD, FRCP, 44-1-202-448-265
- Recruiting
Stirling Royal Infirmary
Stirling, England, FK8 2AU
John D. Steven, MD, 44-1786-434-000, john.steven@fvah.scot.nhs.uk
- Recruiting
Taunton and Somerset Hospital
Taunton Somerset, England, TA1 5DA
Orla McNally, MD, 44-1823-342-562
- Recruiting
Royal Cornwall Hospital
Truro, Cornwall, England, TR1 3LJ
Contact Person, 44-1872-250-000
- Recruiting
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Contact Person, 44-1702-435-555
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- DNA methylation analysis, microarray analysis, polymerase chain reaction, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- 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
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylation analysisGenetic
microarray analysisGenetic
polymerase chain reactionGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
To determine if DNA methylation patterns and expression differentially methylated genes taken before chemotherapy can predict patient outcome with regard to progression-free survival.
Measured: Ongoing
Secondary outcomes (2)
Response
To evaluate whether DNA methylation can predict response.
Measured: ongoing
Methylation changes in tumour
To evaluate the specificity and sensitivity of predicting methylation changes in tumour from the changes at the corresponding CpG islands in plasma
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liz-Anne Lewsley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liz-Anne Lewsley, Cancer Research UK, Glasgow
- Investigators
- Nadeem Siddiqui, MD, Principal investigator, Scottish Gynaecological Cancer Trials Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900289
- Sponsor's protocol ID
- CDR0000577616
- Other IDs
- SCOTTISH-DNA-METHYLATION, EU-20793
- Status last verified
- Feb 2013
- First submitted
- 9 May 2009
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Methylation as a Predictor for Response and Progression-Free Survival in Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00900289
- Acronym / sponsor ID
- CDR0000577616
- Conditions
- Ovarian Cancer
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Liz-Anne LewsleyUniversity, hospital or other
- Study start
- Mar 2002
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA methylation analysis | Genetic | – |
| microarray analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
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.
2 secondary outcomes
Response
Time frame: ongoing
Methylation changes in tumour
Time frame: Ongoing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadeem Siddiqui, MD principal investigator
Scottish Gynaecological Cancer Trials Group
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Liz-Anne Lewsley at 26 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liz-Anne Lewsley (0141 301 7193, liz-anne.lewsley@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.