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Collection of Outcomes Data for Pregnant Patients With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00507572
First received: July 24, 2007
Last updated: September 3, 2014
Last verified: September 2014

July 24, 2007
September 3, 2014
December 2005
December 2019   (final data collection date for primary outcome measure)
Research database of information on patients who are or were pregnant while diagnosed with cancer. [ Time Frame: 14 Years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00507572 on ClinicalTrials.gov Archive Site
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Collection of Outcomes Data for Pregnant Patients With Cancer
Collection of Outcomes Data for Pregnant Patients With Cancer

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.

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.

Observational
Observational Model: Case-Only
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Non-Probability Sample

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

  • Solid Tumors
  • Pregnancy
Other: Data Collection
Information about the type of cancer, type of treatment, and details about pregnancy will be collected.
Pregnant Patients with Cancer
Patients that are or were pregnant when diagnosed with cancer.
Intervention: Other: Data Collection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
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December 2019   (final data collection date for primary outcome measure)

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:

N/A

Female
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No
Contact: Sue Rimes, RN 713-563-4546
United States
 
NCT00507572
2005-0518
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
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Principal Investigator: Andrea Milbourne, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP