Ovarian Cancer Clinical Trial
Official title:
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.
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.
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Observational Model: Case-Only
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