Prognostic Markers of Gynecologic Cancers

NCT00290459 | Completed

• 1 other identifier: 608.03
• Study Type: observational
• Target: 1,321
• Locations: 1 country
• Sites: 1

Brief 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. 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:
2. 2.hysterectomy
3. 3.excisions of cervical dysplasia and/or venereal warts, and
4. 4.therapeutic excisional surgeries to remove gynecologic disease/cancer (uterine, ovarian and lower female genital tract).
5. 5.paracentesis for the symptomatic relief of ascites fluid accumulation (distention).
6. 6.To collect pre-operative blood and urine from patients along with pre- operative blood work drawn for clinical evaluation.
7. 7.De-identify the patients from their donated tissue, blood and urine specimens by assigning a laboratory identification number.
8. 8.Rapidly process and store the collected specimens to preserve biological integrity. (RNA, DNA and proteins)
9. 9.Collect and record the patient's demographic and medical information into a research database under the assigned lab number only.
10. 10.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

Keywords

Gynecologic Disease; Gynecologic Cancer; Prognostic Markers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All female patients undergoing hysterectomy at the Brown Cancer Center

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

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Chen Y, Miller C, Mosher R, Zhao X, Deeds J, Morrissey M, Bryant B, Yang D, Meyer R, Cronin F, Gostout BS, Smith-McCune K, Schlegel R., "Identification of Cervical Cancer Markers by cDNA and Tissue Microarrays," Cancer Research, Vol. 63(8), p.1927 - 1935, April 2003. Nucci MR, Castrillon DH, Bai H, Quade BJ, Ince TA, Genest DR, Lee KR, Mutter GL, Crum CP, "Biomarkers in Diagnostic Obstetric and Gynecologic Pathology: a Review," Adv. Anat. Pathol.,Vol.10(2), p. 55-68, March 2003. Nicolette CA, Miller GA., "The Identification of Clinically Relevant Markers and Therapeutic Targets," Drug Discov. Today, Vol. 8(1), p. 31-38, Jan. 2003. Salvesen HB, Akslen LA., "Molecular Pathogenesis and Prognostic Factors in Endometrial Carcinoma," APMIS, Vol. 110(10), p. 673-689, Oct. 2002. Geisler JP, Geisler HE, "Tumor Markers and Molecular Biological Markers in Gynecologic Malignancies," Curr. Opin. Obstet. Gynecol., Vol. 13(1), p. 31-39, Feb. 2001. Holschneider CH, Berek JS, "Ovarian Cancer: Epidemiology, Biology, and Prognostic Factors," Semin. Surg. Oncol., Vol. 19(1), p. 3-10, Jul-Aug 2000. Framarino dei Malatesta ML, Veneziano M, Peppicelli M, Lanzi G, Marzetti L, "Biologic Prognostic Factors in Ovarian Cancer: a Review," Eur. J. Gynaecol. Oncol., Vol. 19(2), p. 123-125, 1998. Busmanis I, "Biomarkers in Carcinoma of the Cervix: Emphasis on Tissue-Related Factors and their Potential Prognostic Factors," Ann. Acad. Med. Singapore, Vol. 27(5), p. 671-675, Sep. 1998. Grizzle WE, "Biomarkers - The New Frontier in the Pathology of Invasive and Preinvasive Neoplasias," Biotech. Histochem., Vol. 72(2), p. 59-61, March 1997. Grizzle WE, Myers RB, Manne U, "The Use of Biomarker Expression to Characterize Neoplastic Processes," Biotech. Histochem., Vol. 72(2), p. 96-104, March 1997.

  BACKGROUND

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Zhenmin Lei, MD

  University of Louisville, James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: December 1, 2003
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

US (1)