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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

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 2010 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 23, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

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 Intervention
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

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Association between ERCC1 tumor expression and progression-free and overall survival

Secondary Outcome Measures:
  • Association between ERCC1 polymorphisms and ERCC1 tumor expression

Estimated Enrollment: 513
Study Start Date: February 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


  • 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.


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


  • 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


  • Not specified


  • See Disease Characteristics
  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 identifier: NCT01074398

Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Thomas C. Krivak, MD University of Pittsburgh
  More Information

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group Identifier: NCT01074398     History of Changes
Other Study ID Numbers: CDR0000663840
Study First Received: February 23, 2010
Last Updated: February 23, 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:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases processed this record on April 24, 2017