DNA Array Analysis of Patients With Cervical Cancer

November 28, 2017 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with cervical cancer already scheduled to begin radiation therapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cervical cancer tumor biopsy + radiation therapy
Cervical cancer tumor biopsy + radiation therapy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 8 Years
8 Years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2000

Primary Completion (Actual)

November 20, 2017

Study Completion (Actual)

November 20, 2017

Study Registration Dates

First Submitted

August 3, 2007

First Submitted That Met QC Criteria

August 3, 2007

First Posted (Estimate)

August 7, 2007

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDP00-075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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