Clinical trial NCT00299481: Tissue Bank of Biological Specimens From Patients With Gynecologic Disease
Official title: Tissue and Data Acquisition Activity for the Study of Gynecological Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Neoplasms
Uterine Cervical Neoplasms
Ovarian Neoplasms
Leiomyoma
Keywords: Tissue Bank
Endometrial neoplasm
uterine cervical neoplasm
ovarian neoplasm
leiomyoma
DNA
RNA
Protein
Serum
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
Collaborators: name: Walter Reed Army Medical Center
name: Ohio State University
name: University of Pittsburgh
name: Duke University
name: H. Lee Moffitt Cancer Center and Research Institute
name: Windber Research Institute
name: Medstar Health Research Institute
First posted: 2006-03-06
Enrollment: 7000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief 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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Gynecologic Disease Center, Walter Reed Army Medical Center
state: District of Columbia
city: Detroit
country: United States
facility: Wayne State University Kamanos Cancer Institute
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Windber
country: United States
facility: Windber Research Institute
state: Pennsylvania
Study officials:
affiliation: Walter Reed Army Medical Center
name: LTC G. Larry Maxwell, MD
role: PRINCIPAL_INVESTIGATOR
References: