Elizabeth Registry for Low Grade Ovarian Cancer

October 5, 2015 updated by: M.D. Anderson Cancer Center

The Elizabeth Registry for Low Grade Ovarian Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
30 Years
Specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients.
Time Frame: 30 Years
30 Years
Identify potential precursors of low grade and LMP ovarian cancer.
Time Frame: 30 Years
30 Years
Assess treatment patterns to guide management of these diseases.
Time Frame: 30 Years
30 Years
Collect quality of life and health outcomes data on these patients.
Time Frame: 30 Years
30 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Diane C. Bodurka, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

June 27, 2006

First Submitted That Met QC Criteria

June 27, 2006

First Posted (Estimate)

June 28, 2006

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-0359

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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