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DNA Array Analysis of Patients With Cervical Cancer

NCT ID: NCT00512551

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-06-20

Study Completion Date

2017-11-20

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.

Conditions

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Cervical Cancer

Keywords

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Cervical Cancer DNA Array Analysis Gene Expression DNA

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cervical cancer tumor biopsy + radiation therapy

Cervical cancer tumor biopsy + radiation therapy.

Tumor Biopsies

Intervention Type PROCEDURE

Biopsies of the cervical tumor performed first before any treatment is given, and the second about 48 hours after radiation treatment has began.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anuja Jhingran, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

The University of Texas M.D.Anderson Cancer Center

Other Identifiers

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IDP00-075

Identifier Type: -

Identifier Source: org_study_id