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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

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ClinicalTrials.gov Identifier: NCT01074398
Recruitment Status : Unknown
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
First Posted : February 24, 2010
Last Update Posted : February 24, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Genetic: gene expression analysis Genetic: polymorphism analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis

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
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Study Type : Observational
Estimated Enrollment : 513 participants
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
Study Start Date : February 2010
Estimated Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Association between ERCC1 tumor expression and progression-free and overall survival

Secondary Outcome Measures :
  1. Association between ERCC1 polymorphisms and ERCC1 tumor expression

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074398


Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Thomas C. Krivak, MD University of Pittsburgh
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01074398    
Other Study ID Numbers: CDR0000663840
GOG-8012
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: February 24, 2010
Last Verified: February 2010
Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases