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Studying Biomarkers in Blood Samples From Patients With Invasive Cervical Cancer

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ClinicalTrials.gov Identifier: NCT01074424
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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment
Cervical Cancer Genetic: proteomic profiling Other: laboratory biomarker analysis

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 Design
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Study Type : Observational
Estimated Enrollment : 84 participants
Official Title: Development of a Serum Proteomic Profile for Cervical Cancer With Potential Prognostic Value
Study Start Date : February 2010
Estimated Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01074424


Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Samir N. Khleif, MD National Cancer Institute (NCI)
More Information
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Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01074424    
Other Study ID Numbers: CDR0000665346
GOG-8006
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: February 24, 2010
Last Verified: February 2010
Keywords provided by National Cancer Institute (NCI):
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
 cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases