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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
  Purpose

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.


Condition Intervention
Solid Tumors Pregnancy Other: Data Collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Other
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:
  • Research database of information on patients who are or were pregnant while diagnosed with cancer. [ Time Frame: 14 Years ]

Estimated Enrollment: 500
Actual Study Start Date: December 2005
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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:

  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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507572


Contacts
Contact: Sue Rimes, RN 713-563-4546

Locations
United States, Texas
University of Texas MD 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 M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00507572     History of Changes
Other Study ID Numbers: 2005-0518
First Submitted: July 24, 2007
First Posted: July 26, 2007
Last Update Posted: September 14, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Solid Tumors
Pregnancy
Data Collection