Studying Biomarkers in Blood Samples From Patients With Invasive Cervical Cancer

February 23, 2010 updated by: Gynecologic Oncology Group

Development of a Serum Proteomic Profile for Cervical Cancer With Potential Prognostic Value

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

84

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Samir N. Khleif, MD, National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

February 24, 2010

Last Update Submitted That Met QC Criteria

February 23, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000665346
  • GOG-8006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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