MDACC Study Summary 2003-0359

Study Summary
No. 2003-0359:.......Ovary......Diane C. Bodurka......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2003-0359

Study Title:	The Elizabeth Registry for Low Grade Ovarian Cancer

Physician

New Patient Referral



Name:	Diane C. Bodurka	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-3187 Contact us about clinical trials

General Information



Disease Group:	Ovary	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	No return visits required. Participants will be contacted via phone, letter or email annually to update their information.

Treatment Agents:	None	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	No hospital stay required.

Description/
Intervention:

The M. D. Anderson Department of Gynecologic Oncology has established a
national research registry for low grade and low malignant potential (LMP)
ovarian cancer called The Elizabeth Registry for Low Grade Ovarian Cancer.
These cancer types are somewhat rare and little research has been done on
them. The purpose of the Registry to is collect data on patients who have
these cancers, which will then be used to learn more about how these cancers
behave, things that might contribute to the development of these cancers, and
how treatments for these cancers can be improved.

Study Objectives / Outcomes

The proposed registry is designated the Elizabeth Registry in accordance with the wishes of the patient who provided the funding for its development.

The long-term objectives of the Elizabeth Registry are:

1. 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.
2. 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.
3. To specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients.
4. To identify potential precursors of low grade and LMP ovarian cancer.
5. To assess treatment patterns to guide management of these diseases.
6. To collect quality of life and health outcomes data on these patients.
7. 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 Registry will be ongoing and will ultimately include both UTMDACC and non-UTMDACC patients. However, the goal of this initial protocol is to establish the framework of the Registry and to develop the mechanics of its operation by first registering current and former UTMDACC patients.

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.

Study Status Information



Study Activation / Registration Date:	09/30/2003

IRB Review and Approval Date:	09/17/2003

Study Type:	Not Applicable

Recruitment Status:	Closed

Projected Accrual:	indefinite

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00345709
Study Information on Clinical Trials Registry (clinicaltrials.gov)