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Studying Biomarkers in Blood Samples From Patients With Invasive Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
proteomic profiling
laboratory biomarker analysis
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cervical Cancer focused on measuring stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive adenocarcinoma, squamous cell carcinoma, or adenosquamous cell carcinoma of the cervix

    • Stage IIB, III, or IVA disease
  • Eligible and evaluable for GOG-0191
  • Pre- and/or post-treatment serum specimens available for proteomic analysis

PATIENT CHARACTERISTICS:

  • Patient has given consent to allow their specimen(s) to be used for future cancer research

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Generation of a serum proteomic profile using banked pre-treatment serum specimens that may have potential utility for cervical cancer prognosis (overall survival and progression-free survival [PFS])

    Secondary Outcome Measures

    Generation of a serum proteomic profile using banked post-treatment serum specimens that may have potential utility for cervical cancer prognosis (overall survival and PFS)

    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
    NCT01074424
    Brief Title
    Studying Biomarkers in Blood Samples From Patients With Invasive Cervical Cancer
    Official Title
    Development of a Serum Proteomic Profile for Cervical Cancer With Potential Prognostic Value
    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 from patients with cancer in the laboratory may help doctors identify and learn more about 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 blood samples from patients with invasive cervical cancer.
    Detailed Description
    OBJECTIVES: Primary To develop a serum proteomic profile for cervical cancer using banked pre-treatment serum specimens from patients with invasive cervical cancer and to determine if this serum proteomic profile has possible utility in cervical cancer prognosis. Secondary To develop a serum proteomic profile for cervical cancer using banked post-treatment serum specimens from these patients and to determine if this serum proteomic profile has possible utility in cervical cancer prognosis. OUTLINE: This is a multicenter study. Banked serum specimens are used to generate proteomic profiles.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer
    Keywords
    stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma

    7. Study Design

    Enrollment
    84 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Genetic
    Intervention Name(s)
    proteomic profiling
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Primary Outcome Measure Information:
    Title
    Generation of a serum proteomic profile using banked pre-treatment serum specimens that may have potential utility for cervical cancer prognosis (overall survival and progression-free survival [PFS])
    Secondary Outcome Measure Information:
    Title
    Generation of a serum proteomic profile using banked post-treatment serum specimens that may have potential utility for cervical cancer prognosis (overall survival and PFS)

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed invasive adenocarcinoma, squamous cell carcinoma, or adenosquamous cell carcinoma of the cervix Stage IIB, III, or IVA disease Eligible and evaluable for GOG-0191 Pre- and/or post-treatment serum specimens available for proteomic analysis PATIENT CHARACTERISTICS: Patient has given consent to allow their specimen(s) to be used for future cancer research PRIOR CONCURRENT THERAPY: See Disease Characteristics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Samir N. Khleif, MD
    Organizational Affiliation
    National Cancer Institute (NCI)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Studying Biomarkers in Blood Samples From Patients With Invasive Cervical Cancer

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