Collection of Outcomes Data for Pregnant Patients With Cancer - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00507572

Purpose

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.

Condition	Intervention
Solid Tumors Pregnancy	Other: Data Collection

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only
Official Title:	Collection of Outcomes Data for Pregnant Patients With Cancer

Further study details as provided by M.D. Anderson Cancer Center:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	December 2005
Estimated Primary Completion Date:	December 2019 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients that are or were pregnant when diagnosed with cancer.	Other: Data Collection Information about the type of cancer, type of treatment, and details about pregnancy will be collected.

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Study participants that are or were pregnant when diagnosed with cancer.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507572

Contacts

Contact: Sue Rimes, RN

713-563-4546

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Andrea Milbourne, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Andrea Milbourne, MD

U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Andrea Milbourne, MD/Associate Professor )
Study ID Numbers:	2005-0518
Study First Received:	July 24, 2007
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00507572
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Solid Tumors
Pregnancy
Data Collection

ClinicalTrials.gov processed this record on January 16, 2009