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Trial Title: Tissue Bank of Biological Specimens From Patients With Gynecologic Disease

NCT ID: NCT00299481

Condition: Endometrial Neoplasms
Uterine Cervical Neoplasms
Ovarian Neoplasms
Leiomyoma

Conditions: Official terms:
Neoplasms
Ovarian Neoplasms
Leiomyoma
Myofibroma
Uterine Cervical Neoplasms
Endometrial Neoplasms

Conditions: Keywords:
Tissue Bank
Endometrial neoplasm
uterine cervical neoplasm
ovarian neoplasm
leiomyoma
DNA
RNA
Protein
Serum

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

Summary: The purpose of this study is to create a tissue bank of gynecologic cancers and normal tissue for the study of cancer in order to better understand the changes occurring on a molecular level (DNA, RNA, protein) that lead to the development of cancer.

Detailed description: Cancer arises due to genetic alterations that disrupt numerous cellular functions including proliferation, programmed cell death and senescence, that ultimately control the number of cells in a population. The genetic damage that underlies the development of cancers has a diverse etiology and loss of DNA repair mechanisms also may play a role in allowing mutations to accumulate. Cancers are also characterized by the ability to invade surrounding tissues and to metastasize. Many of the molecular alterations involved in this process have yet to be elucidated. Gynecologic cancers afflict women of all ages. Cervical cancer is the most common gynecologic malignancy worldwide, accounting for over 400,000 cases annually. Endometrial cancer is the most common gynecologic malignancy with approximately 33,000 new cases being diagnosed annually in American women. Ovarian cancer is the fourth most common cause of cancer related mortality in American women, with approximately 14,000 deaths occurring from it in 2000. The creation of a tissue repository containing tissue specimens, blood/serum, and molecular extracts (DNA, RNA, protein) will provide a rich source of tissue for future gynecological disease research studies.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients scheduled to undergo surgery for diagnosis and treatment of a gynecologic disease at one of the participating institutions - > = 18 years old - Ability to read English Exclusion Criteria: - < 18 years old

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Washington Hospital Center

Address:
City: Washington
Zip: 20010
Country: United States

Status: Recruiting

Contact:
Last name: Velega E Roberts, RN, MS

Phone: 202-877-8517
Email: Velega.E.Roberts@medstar.net

Investigator:
Last name: Jonathon Cosin, MD
Email: Principal Investigator

Facility:
Name: Gynecologic Disease Center, Walter Reed Army Medical Center

Address:
City: Washington
Zip: 20307
Country: United States

Status: Recruiting

Contact:
Last name: Cynthia A Perry, MS

Phone: (202) 782-8461
Email: Cynthia.Perry@amedd.army.mil

Contact backup:
Last name: Karen Livornese, RNC, BSN, CCRC

Phone: (202) 782-6244
Email: Karen.Livornese@amedd.army.mil

Investigator:
Last name: LTC G. Larry Maxwell, MD
Email: Principal Investigator

Facility:
Name: Wayne State University Kamanos Cancer Institute

Address:
City: Detroit
Zip: 48201
Country: United States

Status: Not yet recruiting

Contact:
Last name: Alison Fried

Phone: 313-576-9446
Email: afried@med.wayne.edu

Investigator:
Last name: Robert T Morris, MD
Email: Principal Investigator

Facility:
Name: Duke University Medical Center

Address:
City: Durham
Zip: 27710
Country: United States

Status: Recruiting

Contact:
Last name: Barbara Walukas, RN

Phone: 919-684-6159
Email: barbara.walukas@duke.edu

Investigator:
Last name: Andrew Berchuck, MD
Email: Principal Investigator

Facility:
Name: The Ohio State University

Address:
City: Columbus
Zip: 43210
Country: United States

Status: Recruiting

Contact:
Last name: Michele Vaughan

Phone: 614-582-0280
Email: vaughan-2@medctr.osu.edu

Investigator:
Last name: Jeffrey Fowler, MD
Email: Principal Investigator

Facility:
Name: University of Pittsburgh Medical Center

Address:
City: Pittsburgh
Zip: 15232
Country: United States

Status: Recruiting

Contact:
Last name: Tracy Davis, RN

Phone: 412-641-1157
Email: tdavis@mail.magee.edu

Investigator:
Last name: Robert Edwards, MD
Email: Principal Investigator

Facility:
Name: Windber Research Institute

Address:
City: Windber
Zip: 15963
Country: United States

Status: Not yet recruiting

Contact:
Last name: Micheal Liebman, PhD

Phone: 814-467-9844

Investigator:
Last name: Micheal Liebman, PhD
Email: Principal Investigator

Start date: March 2006

Completion date: January 2011

Lead sponsor:
Agency: U.S. Army Medical Research and Development Command
Agency class: U.S. Fed

Collaborator:
Agency: Walter Reed Army Medical Center
Agency class: U.S. Fed

Collaborator:
Agency: Ohio State University
Agency class: Other

Collaborator:
Agency: University of Pittsburgh
Agency class: Other

Collaborator:
Agency: Duke University
Agency class: Other

Collaborator:
Agency: H. Lee Moffitt Cancer Center and Research Institute
Agency class: Other

Collaborator:
Agency: Windber Research Institute
Agency class: Other

Collaborator:
Agency: Medstar Health Research Institute
Agency class: Other

Source: Walter Reed Army Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00299481

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