Collection of Outcomes Data for Pregnant Patients With Cancer

April 2, 2024 updated by: M.D. Anderson Cancer Center
This study collects treatment and outcomes information on pregnant patients who are or were pregnant with cancer. Gathering and storing health information on pregnant patients with cancer, may provide data for future research studies and improve patient care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To collect, both prospectively and retrospectively, data on disease characterization, treatment and outcome for pregnant patients with malignancies seen at M. D. Anderson Cancer Center.

II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and pregnancy 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.

OUTLINE:

Patients' medical records are reviewed prospectively and retrospectively.

Study Type

Observational

Enrollment (Estimated)

500

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:
          • Andrea M. Milbourne
          • Phone Number: 713-745-6986
        • Principal Investigator:
          • Andrea M. Milbourne

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

Pregnant patients with cancer and patients known to have been pregnant with a diagnosis of cancer

Description

Inclusion Criteria:

  • All pregnant patients with cancer and patients known to have been pregnant with a diagnosis of cancer are eligible, regardless of their diagnosis or treatment plan
  • Patients may receive prenatal care from any obstetrician, but a consult with Maternal Fetal Medicine is encouraged

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 (medical chart review)
Patients' medical records are reviewed prospectively and retrospectively.
Other: Medical Chart Review
Medical records are reviewed
Other Names:
  • Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Creation of data repository for patient characteristics, treatment, and pregnancy outcome data
Time Frame: Up to 15 years
Up to 15 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: Andrea M Milbourne, 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)

December 19, 2005

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

July 24, 2007

First Submitted That Met QC Criteria

July 25, 2007

First Posted (Estimated)

July 26, 2007

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-0518 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-07509 (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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