Prognostic Markers of Gynecologic Cancers

Completed

Conditions studied: Gynecologic Disease, Gynecologic Cancer

In brief

This proposal seeks to retain "discard" pieces of human gynecologic tissues and "discard" ascites fluid collected during normal surgical procedures, along with corresponding blood samples and urine, for research involving prognostic markers of disease/cancer. The specific aims of the proposal include: 1. To collect "discard" pieces of benign, pre-malignant and malignant gynecologic tissues, "discard" ascites fluid and, when possible, corresponding blood and urine specimens from patients undergoing: 1. hysterectomy 2. excisions of cervical dysplasia and/or venereal warts, and 3. therapeutic excisional surgeries to remove gynecologic disease/cancer (uterine, ovarian and lower female genital tract). 4. paracentesis for the symptomatic relief of ascites fluid accumulation (distention). 2. To collect pre-operative blood and urine from patients along with pre- operative blood work drawn for clinical evaluation. 3. De-identify the patients from their donated tissue, blood and urine specimens by assigning a laboratory identification number. 4. Rapidly process and store the collected specimens to preserve biological integrity. (RNA, DNA and proteins) 5. Collect and record the patient's demographic and medical information into a research database under the assigned lab number only. 6. Assess the specimens for prognostic markers of gynecologic disease/cancer by molecular techniques such as DNA arrays,immunohistochemistry and ELISA.

Key facts

Study ID

NCT00290459

Run by

University of Louisville

People needed

1321

Starts

2003-12-01

Expected to finish

2021-03-26

Last updated by the study team

2021-03-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• all female patients older than 18 years of age who are:
• undergoing hysterectomy
• excisions of cervical dysplasia and/or venereal warts
• therapeutic excisional surgeries for any benign or malignant gynecologic disease
• paracentesis procedure for the symptomatic relief of ascites fluid accumulation (distention)

You may not qualify if…

• women who are pregnant
• women who are HIV or Hepatitis C positive
• women who are enrolled in a current clinical trial utilizing the specimens

Where it is running

• James Graham Brown Cancer Center — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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