Elizabeth Registry for Low Grade Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

The Elizabeth Registry for Low Grade Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345709
• Other study ID #: 2003-0359
• Status: Completed
• Phase: N/A
• First received: June 27, 2006
• Last updated: October 5, 2015
• Start date: September 2003
• Est. completion date: October 2014

Study information

• Verified date: October 2015
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Questionnaire
65 page questionnaire that contains questions about your ovarian cancer diagnosis, gynecologic history, family history, general medical history, and health risk factors.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		30 Years	No
Secondary	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.		30 Years	No
Secondary	Specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients.		30 Years	No
Secondary	Identify potential precursors of low grade and LMP ovarian cancer.		30 Years	No
Secondary	Assess treatment patterns to guide management of these diseases.		30 Years	No
Secondary	Collect quality of life and health outcomes data on these patients.		30 Years	No

External Links

•   University of Texas MD Anderson Cancer Center Website