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Study Summary
No. 2006-0137:.......Ovary......David Gershenson......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:
2006-0137
Study Title:Data Collection for Patients with Low Grade Ovarian Carcinoma
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Physician New Patient Referral
Name:David GershensonPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-4535
Contact us about clinical trials
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General Information
Disease Group:OvarySupported By:N/A
Phase of Study:N/AReturn
Visit:
Not applicable
Treatment
Agents:
NoneHome Care:Not applicable
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Not applicable
Description/
Intervention:
The goal of this psychosocial research study is to collect information on
patients with one of the above-mentioned low-grade tumors. Researchers want to
maintain these patients' information in a research database to help learn and
better understand these tumor types and to help develop better treatments for
them.
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Study Objectives / Outcomes
Primary objectives:
    1. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1000 female patients with low-grade ovarian and peritoneal tumors. These include ovarian tumors of low malignant potential, low-grade serous ovarian carcinoma, primary peritoneal tumors of low malignant potential, low-grade carcinomas of the peritoneum, and psammocarcinoma.
    2. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.
    3. To have a single data repository, kept on a secure platform that will integrate clinical information and research findings and serve as a secure archive for future research.

Secondary objectives:
    1. To obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank. These samples will serve as the basis for future studies.
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Study Status Information
Study Activation / Registration Date:05/19/2006
IRB Review and Approval Date:05/17/2006
Study Type:Observational
Recruitment Status:Open
Projected Accrual:N/A
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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) All patients seen at M.D. Anderson Cancer Center with the following tumor types or diagnosis are eligible for inclusion in this database. This includes patients whose disease progressed to a higher-grade carcinoma since the time of original diagnosis: Ovarian tumor of low malignant potential, Low-grade serous carcinoma of the ovary, Primary peritoneal tumor of low malignant potential, Low-grade serous carcinoma of the peritoneum, Psammocarcinoma

Exclusion Criteria:1) None

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Links
Registration Number: NCT00488878
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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