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Completed

NCT Number: NCT00345709

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients.

    Time frame: 30 Years

  3. Identify potential precursors of low grade and LMP ovarian cancer.

    Time frame: 30 Years

  4. Assess treatment patterns to guide management of these diseases.

    Time frame: 30 Years

  5. Collect quality of life and health outcomes data on these patients.

    Time frame: 30 Years

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

The Elizabeth Registry for Low Grade Ovarian Cancer

Important dates

Study start
2003
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2006
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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