DNA Array Analysis of Patients With Cervical Cancer

Completed

• Conditions: Cervical Cancer
• Interventions: Procedure: Tumor Biopsies

• Registration Number: NCT00512551
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2000-06-20
• Study First Submitted: 2007-08-03
• Study First Submitted QC: 2007-08-03
• Study First Posted: 2007-08-07
• Status Verified: 2017-11
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-20
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

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Exclusion Criteria

1. Previous cervical cancer treatment including but not limited to transvaginal cone irradiation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cervical cancer tumor biopsy + radiation therapy	Tumor Biopsies	Cervical cancer tumor biopsy + radiation therapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Researchers will study a large number of genes located in tumor material to learn this information.	8 Years

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States