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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00488878
Other study ID # 2006-0137
Secondary ID NCI-2020-1334120
Status Recruiting
Phase
First received
Last updated
Start date May 19, 2006
Est. completion date May 1, 2035

Study information

Verified date February 2024
Source M.D. Anderson Cancer Center
Contact Lisa Nathan
Phone 713-745-3837
Email lcnathan@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study collects information to maintain a database on patients with low-grade ovarian or peritoneal tumors. Collecting information about the type of cancer and treatment, as well as details about follow-up care, may help researchers learn and better understand these tumor types and help develop better treatments for them.


Description:

PRIMARY OBJECTIVES: I. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1600 female patients with low-grade ovarian and peritoneal tumors. II. 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. III. 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 OBJECTIVE: I. To obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank. OUTLINE: Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date May 1, 2035
Est. primary completion date May 1, 2034
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Patients' residual tissue samples are collected
Other:
Electronic Health Record Review
Medical records are reviewed

Locations

Country Name City State
United States M D 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 Prospective and retrospective data collection on disease characterization, treatment, and outcomes Up to 28 years
Primary Organization of clinical information Will be done in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome. Up to 28 years
Primary Creation of a single data repository to integrate clinical information and research findings Up to 28 years
Secondary Collection and storage of human tumor samples for the establishment of a tumor bank Up to 28 years
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