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Elizabeth Registry for Low Grade Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00345709
First received: June 27, 2006
Last updated: October 22, 2014
Last verified: October 2014
  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.

The short-term objectives are:

  • To detail procedures for potential registrant identification and recruitment.
  • To create a demographic and health history questionnaire for potential registrants.
  • To begin aggregating low grade and low malignant potential ovarian tumor blocks.
  • To specify a timeline for the development of all other aspects of the Registry.

Condition Intervention
Ovarian Cancer
Behavioral: Questionnaire

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

Resource links provided by NLM:


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 ]

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
National Research Registry Enrollment
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.
Other Name: Survey

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. This study is partially funded by a research grant from the Elizabeth Fund for the Study of Low Grade Ovarian Carcinoma.

  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:

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

Exclusion Criteria:

  1. UTMDACC patients, living or deceased, whose diagnosis of either low grade ovarian carcinoma or LMP ovarian carcinoma has not been confirmed pathologically.
  2. Any type of ovarian cancer other than low grade or LMP ovarian carcinoma.
  3. Unable to speak and read English (for patients who are living).
  4. Residence outside the United States, either at time of original diagnosis or at time of accession to the Registry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Diane C. Bodurka, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00345709     History of Changes
Other Study ID Numbers: 2003-0359
Study First Received: June 27, 2006
Last Updated: October 22, 2014
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014