Pre-Clinical Models in Gynecological Tumors A Tissue Repository
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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 |
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 |
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 |
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.
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| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| 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 Adenoma Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Diseases Genital Diseases, Female Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 16, 2013