Overview

This trial is active, not recruiting.

Condition cervical cancer
Treatment tumor biopsies
Sponsor M.D. Anderson Cancer Center
Start date June 2000
End date December 2017
Trial size 18 participants
Trial identifier NCT00512551, IDP00-075

Summary

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. Researchers will study a large number of genes located in tumor material to learn this information.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Cervical cancer tumor biopsy + radiation therapy.
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Researchers will study a large number of genes located in tumor material to learn this information.
time frame: 8 Years

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: 1. Newly diagnosed cervical cancer: clinical Stage IB -IIIB 2. Invasive pure squamous cell carcinoma 3. Planned treatment with concurrent cisplatinum/5-fluorouracil chemotherapy and pelvic radiation Exclusion Criteria: 1. Previous cervical cancer treatment including but not limited to transvaginal cone irradiation

Additional Information

Official title A Pilot Study of Early Changes in DNA Array Expression Following Chemo-Radiation Treatment of Cervical Cancer
Principal investigator Anuja Jhingran, MD
Description 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, hematoxylin 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.