Collection of Outcomes Data for Pregnant Patients With Cancer
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Purpose
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 Pregnancy |
Other: Data Collection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | Collection of Outcomes Data for Pregnant Patients With Cancer |
- 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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study participants that are or were pregnant when diagnosed with cancer.
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 a Maternal Fetal Medicine physician is encouraged.
Exclusion Criteria:
N/A
Contacts and Locations| Contact: Sue Rimes, RN | 713-563-4546 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Andrea Milbourne, MD | |
| Principal Investigator: | Andrea Milbourne, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00507572 History of Changes |
| Other Study ID Numbers: | 2005-0518 |
| Study First Received: | July 24, 2007 |
| Last Updated: | February 21, 2013 |
| 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 May 16, 2013