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
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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 |
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 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 |

- Association between ERCC1 tumor expression and progression-free and overall survival
- Association between ERCC1 polymorphisms and ERCC1 tumor expression

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

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
Study Chair: | Thomas C. Krivak, MD | University of Pittsburgh |
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 |
recurrent ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
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 |