Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Collection of Outcomes Data for Pregnant Patients With Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: July 24, 2007
Last updated: January 21, 2015
Last verified: January 2015

The goal of this research study is to collect information on patients who are or were pregnant while diagnosed with cancer and to store this information in a research database.

Condition Intervention
Solid Tumors
Other: Data Collection

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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Research database of information on patients who are or were pregnant while diagnosed with cancer. [ Time Frame: 14 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: December 2005
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant Patients with Cancer
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 MD Anderson since September 2003 until data has been collected for 500 cases. This information will serve as a basis for future studies about pregnant women with cancer. You will receive no special tests or treatment at MD Anderson as a result of this study.

Progress notes and ultrasound reports about your pregnancy will be requested from 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.

Periodically 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.

This is an investigational study. About 500 patients will take part in this study. All will be enrolled at MD Anderson.


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.


Inclusion Criteria:

  1. 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.
  2. Patients may receive prenatal care from any obstetrician, but a consult with a Maternal Fetal Medicine physician is encouraged.

Exclusion Criteria:


  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00507572

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Andrea Milbourne, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00507572     History of Changes
Other Study ID Numbers: 2005-0518
Study First Received: July 24, 2007
Last Updated: January 21, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Solid Tumors
Data Collection processed this record on March 03, 2015