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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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
gene expression analysis
polymorphism analysis
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    February 23, 2010
    Last Updated
    February 23, 2010
    Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01074398
    Brief Title
    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
    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 Type
    Observational

    2. Study Status

    Record Verification Date
    February 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    March 2010 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
    Keywords
    recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer

    7. Study Design

    Enrollment
    513 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Genetic
    Intervention Name(s)
    gene expression analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    polymorphism analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    protein expression analysis
    Intervention Type
    Other
    Intervention Name(s)
    immunohistochemistry staining method
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Primary Outcome Measure Information:
    Title
    Association between ERCC1 tumor expression and progression-free and overall survival
    Secondary Outcome Measure Information:
    Title
    Association between ERCC1 polymorphisms and ERCC1 tumor expression

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas C. Krivak, MD
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30633128
    Citation
    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. Erratum In: Obstet Gynecol. 2019 Apr;133(4):830.
    Results Reference
    derived

    Learn more about this trial

    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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