Fallopian Tube CancerNCT01074398
Biomarkers in Predicting Response in Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Treated on GOG-0172 or GOG-0182
An observational study of Fallopian Tube Cancer and Ovarian Cancer, run by Gynecologic Oncology Group.
Trial summary
RATIONALE: Studying samples of blood and tumor tissue 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 well patients will respond to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
- What is being tested?
- gene expression analysis, polymorphism analysis and protein expression analysis
- How many people
- 513 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Mar 2010
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced invasive ovarian epithelial carcinoma, fallopian tube adenocarcinoma, or primary peritoneal carcinoma
- Has undergone optimal surgical staging
- Has received chemotherapy on either GOG-0172 or GOG-0182
- Adequate blood or DNA available for ERCC1 analysis
- Adequate tumor on paraffin-embedded tissue for IHC staining
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: ERCC1 Expression as a Predictor of Progression Free and Overall Survival in Patients With Epithelial Ovarian Cancer Treated on GOG Protocols 0172 and 0182
RATIONALE: Studying samples of blood and tumor tissue 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 well patients will respond to treatment.
PURPOSE: This research study is looking at biomarkers in predicting response in patients with advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate ERCC1 tumor expression, as measured by IHC, as a predictor of progression-free and overall survival of patients with advanced ovarian epithelial cancer.
Secondary
- To correlate ERCC1 single-nucleotide polymorphisms (C8092A and codon 118) with ERCC1 tumor expression.
OUTLINE: This is a multicenter study.
Blood and paraffin-embedded tumor tissue samples are analyzed for ERCC1 tumor expression by IHC and single-nucleotide polymorphisms.
- Being tested
- gene expression analysis, polymorphism analysis, protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
polymorphism analysisGenetic
protein expression analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between ERCC1 tumor expression and progression-free and overall survival
Secondary outcomes (1)
Association between ERCC1 polymorphisms and ERCC1 tumor expression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fallopian Tube 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
- Enrolment
- 513 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Thomas C. Krivak, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074398
- Sponsor's protocol ID
- CDR0000663840
- Other IDs
- GOG-8012
- Status last verified
- Feb 2010
- First submitted
- 23 Feb 2010
- Last updated
- 24 Feb 2010
- Results posted
- No
Publications
Rose PG, Java JJ, Salani R, Geller MA, Secord AA, Tewari KS, Bender DP, Mutch DG, Friedlander ML, Van Le L, Method MW, Hamilton CA, Lee RB, Wenham RM, Guntupalli SR, Markman M, Muggia FM, Armstrong DK, Bookman MA, Burger RA, Copeland LJ. Nomogram for Predicting Individual Survival After Recurrence of Advanced-Stage, High-Grade Ovarian Carcinoma. Obstet Gynecol. 2019 Feb;133(2):245-254. doi: 10.1097/AOG.0000000000003086.
PubMed 30633128
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERCC1 Expression as a Predictor of Progression Free and Overall Survival in Patients With Epithelial Ovarian Cancer Treated on GOG Protocols 0172 and 0182
- ClinicalTrials.gov ID
- NCT01074398
- Acronym / sponsor ID
- CDR0000663840
- Keywords
- recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 513 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (estimated)
- First posted
- 24 Feb 2010 (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 samples of blood and tumor tissue 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 well patients will respond to treatment.
PURPOSE: This research study is looking at biomarkers in predicting response in patients with advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate ERCC1 tumor expression, as measured by IHC, as a predictor of progression-free and overall survival of patients with advanced ovarian epithelial cancer.
Secondary
- To correlate ERCC1 single-nucleotide polymorphisms (C8092A and codon 118) with ERCC1 tumor expression.
OUTLINE: This is a multicenter study.
Blood and paraffin-embedded tumor tissue samples are analyzed for ERCC1 tumor expression by IHC and single-nucleotide polymorphisms.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| gene expression analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Association between ERCC1 tumor expression and progression-free and overall survival
1 secondary outcome
Association between ERCC1 polymorphisms and ERCC1 tumor expression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2010.
- Derived from this study: PubMed 30633128Rose PG, Java JJ, Salani R, Geller MA, Secord AA, Tewari KS, Bender DP, Mutch DG, Friedlander ML, Van Le L, Method MW, Hamilton CA, Lee RB, Wenham RM, Guntupalli SR, Markman M, Muggia FM, Armstrong DK, Bookman MA, Burger RA, Copeland LJ. Nomogram for Predicting Individual Survival After Recurrence of Advanced-Stage, High-Grade Ovarian Carcinoma. Obstet Gynecol. 2019 Feb;133(2):245-254. doi: 10.1097/AOG.0000000000003086.
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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.
Thomas C. Krivak, MD study chair
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Fallopian Tube Cancer and Ovarian Cancer, run by Gynecologic Oncology Group.
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 24 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between ERCC1 tumor expression and progression-free and overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01074398, which also lists 1 linked publication.
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 24 Feb 2010.