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NCT01074424 Clinical Trial

Studying Biomarkers in Blood Samples From Patients With Invasive Cervical Cancer

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01074424
Other study ID # CDR0000665346
Secondary ID GOG-8006
Status Not yet recruiting
Phase N/A
First received February 23, 2010
Last updated February 23, 2010
Start date February 2010

Study information
Verified date February 2010
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 84
Est. completion date
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Intervention

Genetic:
• proteomic profiling

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary 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]) No
Secondary 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) No
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