Endometrial NeoplasmsNCT00299481
Tissue Bank of Biological Specimens From Patients With Gynecologic Disease
An observational study of Endometrial Neoplasms and Uterine Cervical Neoplasms, run by U.S. Army Medical Research and Development Command at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms
- How many people
- 7,000 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2006to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 18 years old
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Michele Vaughan, 614-582-0280, vaughan-2@medctr.osu.edu
Jeffrey Fowler, MD
- Not yet recruiting
Wayne State University Kamanos Cancer Institute
Detroit, Michigan, 48201
Alison Fried, 313-576-9446, afried@med.wayne.edu
Robert T Morris, MD
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Barbara Walukas, RN, 919-684-6159, barbara.walukas@duke.edu
Andrew Berchuck, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Tracy Davis, RN, 412-641-1157, tdavis@mail.magee.edu
Robert Edwards, MD
- Recruiting
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Velega E Roberts, RN, MS, 202-877-8517, Velega.E.Roberts@medstar.net
Jonathon Cosin, MD
- Recruiting
Gynecologic Disease Center, Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
Cynthia A Perry, MS, (202) 782-8461, Cynthia.Perry@amedd.army.mil
Karen Livornese, RNC, BSN, CCRC, (202) 782-6244, Karen.Livornese@amedd.army.mil
- Not yet recruiting
Windber Research Institute
Windber, Pennsylvania, 15963
Micheal Liebman, PhD, 814-467-9844
Micheal Liebman, PhD
About this study
Official title: Tissue and Data Acquisition Activity for the Study of Gynecological Disease
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.
Read the 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.
- Keywords
- Tissue Bank, Endometrial neoplasm, uterine cervical neoplasm, ovarian neoplasm, leiomyoma, DNA, RNA, Protein, Serum
- Medical subject headings
- Endometrial Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Leiomyoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startMar 2006
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Medical Center, Ohio State University, University of Pittsburgh, Duke University, H. Lee Moffitt Cancer Center and Research Institute, Windber Research Institute, Medstar Health Research Institute
- Investigators
- LTC G. Larry Maxwell, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299481
- Sponsor's protocol ID
- 04-44017
- Other IDs
- W81XWH-05-2-0005, A-12818.1a
- Status last verified
- Jun 2008
- First submitted
- 2 Mar 2006
- Last updated
- 30 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue and Data Acquisition Activity for the Study of Gynecological Disease
- ClinicalTrials.gov ID
- NCT00299481
- Acronym / sponsor ID
- 04-44017
- Keywords
- Tissue Bank, Endometrial neoplasm, uterine cervical neoplasm, ovarian neoplasm, leiomyoma, DNA, RNA, Protein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Medical Center, Ohio State University, University of Pittsburgh, Duke University, H. Lee Moffitt Cancer Center and Research Institute, Windber Research Institute, Medstar Health Research Institute
- Study start
- Mar 2006
- Study completion
- Jan 2011
- First posted
- 6 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LTC G. Larry Maxwell, MD principal investigator
Walter Reed Army Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Neoplasms and Uterine Cervical Neoplasms, run by U.S. Army Medical Research and Development Command at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cynthia A Perry, CIP ((202) 782-8461, cynthia.perry@amedd.army.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2008.