Pre-Clinical Models in Gynecological Tumors A Tissue Repository

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00250783
First received: November 4, 2005
Last updated: January 6, 2010
Last verified: July 2009
  Purpose

The purpose of this study is to provide a repository for long-term storage of endometrial cancer tumor and normal tissue, ascites and serum. This material will be used in studies to better understand the molecular biology of endometrial cancer.


Condition
Endometrial Neoplasms
Uterine Neoplasms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pre-Clinical Models in Gynecological Tumors: A Tissue Repository

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Biospecimen Retention:   Samples Without DNA

Tumor and normal tissues, ascites, and/or serum, and/or urine from women with malignant or premalignant gynecological conditions for which they are undergoing medically-indicated surgery, and normal tissues from women without malignancy who volunteer to donate serum and/or tissue at the time of medically indicated surgery


Enrollment: 26
Study Start Date: July 2002
Study Completion Date: January 2008
Detailed Description:

BACKGROUND AND RATIONALE

This protocol will create a central repository for banking tumor and other tissues as well as serum from patients with uterine corpus tumors. In addition, this protocol will also serve as a central repository for serum and tissue to healthy post-menopausal and peri-menopausal controls.

There will be an "internal" bank. The internal bank will have samples available to UNM investigators.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

tumor and normal tissues, ascites, and/or serum, and/or urine from women with malignant or premalignant gynecological conditions for which they are undergoing medically-indicated surgery, and normal tissues from women without malignancy who volunteer to donate serum and/or tissue at the time of medically indicated surgery.

Criteria

Inclusion Criteria:

  • All patients undergoing hysterectomy, or who have endometrial cancer, and are under routine surveillance.
  • Patients may have received prior hormonal, cytotoxic chemotherapy, irradiation or surgical therapy.
  • Healthy post-menopausal and peri-menopausal women.
  • A consent form must be signed by the patient prior to study entry.

Exclusion Criteria:

Study Patients:

  • Patients who do not have primary uterine corpus tumors.
  • Patients with less than one gram of tumor tissue available to procurement.

Controls:

  • Patients unwilling to have their medical records reviewed for height, weight, and general medical history (see attached data sheets).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250783

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Harriet Smith, MD University of New Mexico
  More Information

No publications provided

Responsible Party: Harriet O Smith, MD; Principal Investigator, University of New Mexico CRTC
ClinicalTrials.gov Identifier: NCT00250783     History of Changes
Other Study ID Numbers: 2902C
Study First Received: November 4, 2005
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Corpus Uteri
Endometrium
Cancer

Additional relevant MeSH terms:
Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 22, 2014