DNA Array Analysis of Patients With Cervical Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: Tumor Biopsies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed cervical cancer: clinical Stage IB -IIIB Invasive pure squamous cell carcinoma 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cervical cancer tumor biopsy + radiation therapy<br>Cervical cancer tumor biopsy + radiation therapy. | Procedure: Tumor Biopsies<br>* Biopsies of the cervical tumor performed first before any treatment is given, and the second about 48 hours after radiation treatment has began.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Researchers will study a large number of genes located in tumor material to learn this information. |  | 8 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DNA, Cervical Cancer, DNA Array Analysis, Gene Expression