Elizabeth Registry for Low Grade Ovarian Cancer - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00345709

Purpose

Long-Term Objectives:

To establish an ongoing national research registry of epidemiologic, clinical and pathologic data on low grade and low malignant potential (LMP) ovarian cancer patients in UTMDACC's Department of Gynecologic Oncology for research purposes.
To create a bank of low grade and LMP ovarian cancer tumor blocks for study of the molecular and histopathologic differences among low grade ovarian cancer, ovarian LMP tumors and high grade ovarian cancer.
To specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients.
To identify potential precursors of low grade and LMP ovarian cancer.
To assess treatment patterns to guide management of these diseases.
To collect quality of life and health outcomes data on these patients.
To achieve a fundamental understanding of low grade and LMP ovarian cancer that will inform prevention and screening efforts, motivate development of improved treatments and eventually result in a cure.

Condition	Intervention
Ovarian Cancer	Behavioral: Questionnaire

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only
Official Title:	The Elizabeth Registry for Low Grade Ovarian Cancer

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Establish an ongoing national research registry of epidemiologic, clinical and pathologic data on low grade and low malignant potential (LMP) ovarian cancer patients in UTMDACC's Department of Gynecologic Oncology for research purposes. [ Time Frame: 30 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Create a bank of low grade and LMP ovarian cancer tumor blocks for study of the molecular and histopathologic differences among low grade ovarian cancer, ovarian LMP tumors and high grade ovarian cancer. [ Time Frame: 30 Years ] [ Designated as safety issue: No ]
Specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients. [ Time Frame: 30 Years ] [ Designated as safety issue: No ]
Identify potential precursors of low grade and LMP ovarian cancer. [ Time Frame: 30 Years ] [ Designated as safety issue: No ]
Assess treatment patterns to guide management of these diseases. [ Time Frame: 30 Years ] [ Designated as safety issue: No ]
Collect quality of life and health outcomes data on these patients. [ Time Frame: 30 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	99999
Study Start Date:	September 2003
Estimated Primary Completion Date:	September 2033 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patient, living or deceased, with a pathologically-confirmed diagnosis of Ovarian Cancer.	Behavioral: Questionnaire 65 page questionnaire that contains questions about your ovarian cancer diagnosis, gynecologic history, family history, general medical history, and health risk factors.

Detailed Description:

The Registry will be an ongoing research registry that will include patients who have been diagnosed with low grade ovarian, primary peritoneal or fallopian tube or low malignant potential (LMP) ovarian, primary peritoneal or fallopian tube cancer.

In order to enroll in the Registry, you will be asked to complete a 65 page questionnaire that contains questions about your ovarian cancer diagnosis, gynecologic history, family history, general medical history, and health risk factors. This questionnaire will take about 1 hour to complete.

In addition, researchers will look at your medical record and pathology samples stored at M. D. Anderson to get information about your surgeries, treatments, disease course, and tumor grade. If your original surgery was not performed at M. D. Anderson, you may be asked to provide tumor specimens from that surgery before enrolling in the Registry.

You will be contacted annually by the Registry Coordinator to update your demographic and health information.

This is an investigational study. The Registry will eventually enroll both M. D. Anderson and non-M. D. Anderson patients. The number of registrants is unlimited because the Registry will be ongoing.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

M.D. Anderson Cancer Center Patient, living or deceased, with a pathologically-confirmed diagnosis of either low grade ovarian carcinoma or LMP ovarian carcinoma.

Criteria

Inclusion Criteria:

UTMDACC patient, living or deceased, with a pathologically-confirmed diagnosis of either low grade ovarian carcinoma or LMP ovarian carcinoma.
Able to speak and read English (for patients who are living).
Residence in the United States, both at time of original diagnosis and at time of accession to the Registry.

Exclusion Criteria:

UTMDACC patients, living or deceased, whose diagnosis of either low grade ovarian carcinoma or LMP ovarian carcinoma has not been confirmed pathologically.
Any type of ovarian cancer other than low grade or LMP ovarian carcinoma.
Unable to speak and read English (for patients who are living).
Residence outside the United States, either at time of original diagnosis or at time of accession to the Registry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345709

Contacts

Contact: Diane C. Bodurka, MD

713-563-3187

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Diane C. Bodurka, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Diane C. Bodurka, MD

U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Diane C. Bodurka, MD/Associate Professor )
Study ID Numbers:	2003-0359
Study First Received:	June 27, 2006
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00345709
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Elizabeth Registry

Questionnaire
Registry
Survey

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases

Urogenital Neoplasms
Endocrinopathy
Fallopian tube cancer
Ovarian Diseases
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 13, 2009