DNA Array Analysis of Patients With Cervical Cancer
- To obtain preliminary descriptive data on early changes in tumor DNA array expression following chemo-radiation of cervical cancer. These data will permit the design a future studies to correlate array expression changes with clinical outcome.
- To quantify the degree of therapy-induced apoptosis following chemo-radiation of cervical cancer in order to design future studies to correlate apoptosis levels with clinical outcome.
- To store material to later correlate the tumor DNA array expression with specific strains of tumor-related human papilloma virus (HPV)
- To correlate changes in biomarker expression with clinical outcome and findings of the DNA array analyses.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Pilot Study of Early Changes in DNA Array Expression Following Chemo-Radiation Treatment of Cervical Cancer|
- The goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
- Researchers will study a large number of genes located in tumor material to learn this information. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Two biopsies of the cervix will be performed to obtain tumor cells.
|Study Start Date:||June 2000|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Cervical cancer tumor biopsy + radiation therapy
Cervical cancer tumor biopsy + radiation therapy.
Procedure: Tumor Biopsies
Biopsies of the cervical tumor performed first before any treatment is given, and the second about 48 hours after radiation treatment has began.
Patients in this study are already scheduled to begin radiation therapy. Researchers will get tumor cells by taking two biopsies of the cervix. The first biopsy of the cervical tumor will be done before any treatment is given.
The second biopsy will be performed about 48 hours after the radiation treatment has begun. They will then study the cells in the lab with a new technique for studying gene expression called DNA array, as well as HPV analysis, quantification of apoptosis levels, hematoxilin and eosin staining, and storage of tissue for future research..
The patterns of gene expression in the biopsies will be compared with the success of radiation treatments.
Some of the material will also be stored and used in the future for other research projects.
This is an investigational study. A total of 18 patients will take part in this study. All will be enrolled at UTMDACC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512551
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anuja Jhingran, MD||M.D. Anderson Cancer Center|