Studying Biomarkers in Blood Samples From Patients With Invasive Cervical Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01074424
First received: February 23, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
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Purpose
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 | Intervention |
|---|---|
|
Cervical Cancer |
Genetic: proteomic profiling Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Development of a Serum Proteomic Profile for Cervical Cancer With Potential Prognostic Value |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
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]) [ Designated as safety issue: No ]
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) [ Designated as safety issue: No ]
| Estimated Enrollment: | 84 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders 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 More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01074424 History of Changes |
| Other Study ID Numbers: | CDR0000665346, GOG-8006 |
| Study First Received: | February 23, 2010 |
| Last Updated: | February 23, 2010 |
| Health Authority: | Unspecified |
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:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013