Elizabeth Registry for Low Grade Ovarian Cancer
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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 |
- 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 ]
- 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 |
M.D. Anderson Cancer Center Patient, living or deceased, with a pathologically-confirmed diagnosis of either low grade ovarian carcinoma or LMP ovarian carcinoma.
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| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| 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 18, 2012 |
| 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 Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 23, 2013