Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors

Recruiting

• Conditions: Malignant Ovarian Neoplasm; Low Grade Ovarian Serous Adenocarcinoma; Ovarian Carcinoma; Psammocarcinoma; Primary Peritoneal Low Grade Serous Adenocarcinoma; Primary Peritoneal Carcinoma
• Interventions: Procedure: Biospecimen Collection; Other: Electronic Health Record Review

• Registration Number: NCT00488878
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-05-19
• Study First Submitted: 2007-06-18
• Study First Submitted QC: 2007-06-19
• Study First Posted: 2007-06-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2034-05-01
• Study Completion: 2035-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (electronic health record review)	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.
Observational (electronic health record review)	Biospecimen Collection	Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.

Primary Outcome Measures

Name	Time	Method
Prospective and retrospective data collection on disease characterization, treatment, and outcomes	Up to 28 years
Organization of clinical information	Up to 28 years	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.
Creation of a single data repository to integrate clinical information and research findings	Up to 28 years

Secondary Outcome Measures

Name	Time	Method
Collection and storage of human tumor samples for the establishment of a tumor bank	Up to 28 years

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States