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Collection of Outcomes Data for Pregnant Patients With Cancer

This study is currently recruiting participants.
Verified September 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507572
First Posted: July 26, 2007
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
July 24, 2007
July 26, 2007
September 14, 2017
December 2005
December 2020   (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 ]
Not Provided
Complete list of historical versions of study NCT00507572 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collection of Outcomes Data for Pregnant Patients With Cancer
Collection of Outcomes Data for Pregnant Patients With Cancer

You are being asked to take part in this study because you are pregnant or have been pregnant while diagnosed 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.

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Other
Not Provided
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2020
December 2020   (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 Maternal Fetal Medicine is encouraged.

Exclusion Criteria:

Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact: Sue Rimes, RN 713-563-4546
United States
 
 
NCT00507572
2005-0518
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Andrea Milbourne, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2017