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Gynecologic Disease clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT00290459 Completed - Gynecologic Cancer Clinical Trials

Prognostic Markers of Gynecologic Cancers

Start date: December 2003
Phase:
Study type: Observational

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.