Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345709
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2006-06-27
Brief Title:
Elizabeth Registry for Low Grade Ovarian Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
The Elizabeth Registry for Low Grade Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 UTMDACCs 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
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 UTMDACCs 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None