Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors

NCT ID: NCT00488878

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-19

Study Completion Date

2035-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Low Grade Ovarian Serous Adenocarcinoma Malignant Ovarian Neoplasm Ovarian Carcinoma Primary Peritoneal Carcinoma Primary Peritoneal Low Grade Serous Adenocarcinoma Psammocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Observational (electronic health record review)

Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.

Biospecimen Collection

Intervention Type PROCEDURE

Patients' residual tissue samples are collected

Electronic Health Record Review

Intervention Type OTHER

Medical records are reviewed

Interventions

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Biospecimen Collection

Patients' residual tissue samples are collected

Intervention Type PROCEDURE

Electronic Health Record Review

Medical records are reviewed

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David M Gershenson

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lisa Nathan

Role: CONTACT

713-745-3837

Facility Contacts

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David M. Gershenson

Role: primary

713-563-4535

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2020-13341

Identifier Type: REGISTRY

Identifier Source: secondary_id

2006-0137

Identifier Type: OTHER

Identifier Source: secondary_id

2006-0137

Identifier Type: -

Identifier Source: org_study_id

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