DNA Array Analysis of Patients With Cervical Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
First received: August 3, 2007
Last updated: September 27, 2013
Last verified: September 2013

August 3, 2007
September 27, 2013
June 2000
December 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00512551 on ClinicalTrials.gov Archive Site
Researchers will study a large number of genes located in tumor material to learn this information. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
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DNA Array Analysis of Patients With Cervical Cancer
A Pilot Study of Early Changes in DNA Array Expression Following Chemo-Radiation Treatment of Cervical Cancer

Primary Objectives:

  1. To obtain preliminary descriptive data on early changes in tumor DNA array expression following chemo-radiation of cervical cancer. These data will permit the design a future studies to correlate array expression changes with clinical outcome.
  2. To quantify the degree of therapy-induced apoptosis following chemo-radiation of cervical cancer in order to design future studies to correlate apoptosis levels with clinical outcome.
  3. To store material to later correlate the tumor DNA array expression with specific strains of tumor-related human papilloma virus (HPV)
  4. To correlate changes in biomarker expression with clinical outcome and findings of the DNA array analyses.

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 HPV analysis, quantification of apoptosis levels, hematoxilin 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.

Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA

Two biopsies of the cervix will be performed to obtain tumor cells.

Non-Probability Sample

Patients with cervical cancer already scheduled to begin radiation therapy.

Cervical Cancer
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.
Cervical cancer tumor biopsy + radiation therapy
Cervical cancer tumor biopsy + radiation therapy.
Intervention: Procedure: Tumor Biopsies
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
Not Provided
December 2015   (final data collection date for primary outcome measure)

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

Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Anuja Jhingran, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP