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NCT00512551 Clinical Trial

DNA Array Analysis of Patients With Cervical Cancer

Cervical Cancer Clinical Trial

Official title:
A Pilot Study of Early Changes in DNA Array Expression Following Chemo-Radiation Treatment of Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00512551
Other study ID # IDP00-075
Secondary ID
Status Completed
Phase N/A
First received August 3, 2007
Last updated November 28, 2017
Start date June 20, 2000
Est. completion date November 20, 2017

Study information
Verified date November 2017
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 human papillomavirus (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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date November 20, 2017
Est. primary completion date November 20, 2017
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 8 Years
Secondary Researchers will study a large number of genes located in tumor material to learn this information. 8 Years
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