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


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Open (Enrolling)
Female
Cervical Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

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.

Outcome Time Frame:

8 Years

Safety Issue:

No

Principal Investigator

Anuja Jhingran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

IDP00-075

NCT ID:

NCT00512551

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Cervical Cancer
  • DNA Array Analysis
  • Gene Expression
  • DNA
  • Uterine Cervical Neoplasms

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030