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Prognostic Markers of Gynecologic Cancers

NCT00290459 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1321

Last updated 2021-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Gynecologic Disease
  • Gynecologic Cancer

Sponsors & Collaborators

  • James Graham Brown Cancer Center

    collaborator OTHER

  • University of Louisville

    lead OTHER

Principal Investigators

  • Zhenmin Lei, MD · University of Louisville, James Graham Brown Cancer Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2021-03-26
Completion
2021-03-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00290459 on ClinicalTrials.gov