Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors

February 13, 2024 updated by: M.D. Anderson Cancer Center

Data Collection for Patients With Low Grade Ovarian Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
          • David M. Gershenson
          • Phone Number: 713-563-4535
        • Principal Investigator:
          • David M. Gershenson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a low-grade tumor of Mullerian origin who sought treatment or a second opinion at MD Anderson Cancer Center (MDACC) at any point in the course of their disease and treatment (beginning in January 1950), and patients currently being treated at MDACC or seeking treatment or a second opinion in the future

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Electronic Health Record Review
Medical records are reviewed
Procedure: Biospecimen Collection
Patients' residual tissue samples are collected

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Collection and storage of human tumor samples for the establishment of a tumor bank
Time Frame: Up to 28 years
Up to 28 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: David M Gershenson, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2006

Primary Completion (Estimated)

May 1, 2034

Study Completion (Estimated)

May 1, 2035

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimated)

June 20, 2007

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0137 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-13341 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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