Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors

Primary Peritoneal Carcinoma Clinical Trial

Official title:

Data Collection for Patients With Low Grade Ovarian Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00488878
• Other study ID #: 2006-0137
• Secondary ID: NCI-2020-1334120
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Ovarian Epithelial
• Low Grade Ovarian Serous Adenocarcinoma
• Malignant Ovarian Neoplasm
• Ovarian Carcinoma
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Primary Peritoneal Low Grade Serous Adenocarcinoma
• Psammocarcinoma

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

External Links

•   University of Texas MD Anderson Cancer Center Website