MedDataX Logo

Tissue Bank of Biological Specimens From Patients With Gynecologic Disease

NCT ID: NCT00299481

Last Updated: 2008-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

7000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Leiomyoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Walter Reed Army Medical Center

FED

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role collaborator

Windber Research Institute

OTHER

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

LTC G. Larry Maxwell, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Gynecologic Disease Center, Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Wayne State University Kamanos Cancer Institute

Detroit, Michigan, United States

Site Status NOT_YET_RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

The Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Windber Research Institute

Windber, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cynthia A Perry, CIP

Role: CONTACT

Phone: (202) 782-8461

Email: [email protected]

Karen Livornese, RCN, BSN, CCRC

Role: CONTACT

Phone: (202) 782-6244

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Velega E Roberts, RN, MS

Role: primary

Cynthia A Perry, MS

Role: primary

Karen Livornese, RNC, BSN, CCRC

Role: backup

Alison Fried

Role: primary

Barbara Walukas, RN

Role: primary

Michele Vaughan

Role: primary

Tracy Davis, RN

Role: primary

Micheal Liebman, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

W81XWH-05-2-0005

Identifier Type: -

Identifier Source: secondary_id

A-12818.1a

Identifier Type: -

Identifier Source: secondary_id

04-44017

Identifier Type: -

Identifier Source: org_study_id