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DNA Array Analysis of Patients With Cervical Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00512551
First received: August 3, 2007
Last updated: September 29, 2014
Last verified: September 2014

August 3, 2007
September 29, 2014
June 2000
December 2016   (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 ]
Not Provided
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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

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.

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, 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.

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

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
18
Not Provided
December 2016   (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

Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00512551
IDP00-075
No
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 2014

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