Collection of Outcomes Data for Pregnant Patients With Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 24, 2007

Last Updated Date

November 21, 2008

Start Date ^†

December 2005

Current Primary Outcome Measures ^†

To collect information on patients who are or were pregnant while diagnosed with cancer and to store this information in a research database. [ Time Frame: 14 Years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00507572 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Collection of Outcomes Data for Pregnant Patients With Cancer

Official Title ^†

Collection of Outcomes Data for Pregnant Patients With Cancer

Brief Summary

Primary Objectives:

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.
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.
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.

Detailed Description

If you agree to take part in this study, information about the type of cancer, the type of treatment you have had or are having, and details about your pregnancy will be collected for the database. Data will be collected from patients seen at M. D. Anderson since September 2003 until data has been collected for 200 cases. This study may be completed as soon as 2010 based on the number of pregnant patients we have seen in the last 15 months. This information will serve as a basis for future studies about pregnant women with cancer. You will receive no special tests or treatment at M. D. Anderson as a result of this study.

Progress notes and ultrasound reports about your pregnancy will be requested from UT Maternal Fetal Medicine and/or from your personal obstetrician. This information will be entered into the database and also included in your medical record. If the information is not consistent in the record, we may contact you to clarify the information. You will remain on study until your pregnancy and/or any treatment you are receiving are completed.

Once a year the database will be updated to include information about patient survival. This information is usually found in the medical record however it may be necessary to contact you directly.

About 200 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Phase

Study Type ^†

Observational

Study Design ^†

Case-Only, Other

Condition ^†

Solid Tumors
Pregnancy

Intervention ^†

Other: Data Collection

Study Arms / Comparison Groups

Patients that are or were pregnant when diagnosed with cancer.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

200

Completion Date

Estimated Primary Completion Date

December 2019 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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 UT Maternal Fetal Medicine is encouraged.

Exclusion Criteria: None

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^††

Contact: Sue Rimes, RN

713-563-4546

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00507572

Responsible Party

Andrea Milbourne, MD/Associate Professor, U.T.M.D. Anderson Cancer Center

Secondary IDs ^††

Study Sponsor ^†

M.D. Anderson Cancer Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Andrea Milbourne, MD

U.T.M.D. Anderson Cancer Center

Information Provided By

M.D. Anderson Cancer Center

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.