Collection of Outcomes Data for Pregnant Patients With Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | July 24, 2007 | ||||
| Last Updated Date | February 21, 2013 | ||||
| Start Date ICMJE | December 2005 | ||||
| Estimated Primary Completion Date | December 2019 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Research database of information on patients who are or were pregnant while diagnosed with cancer. [ Time Frame: 14 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00507572 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Collection of Outcomes Data for Pregnant Patients With Cancer | ||||
| Official Title ICMJE | Collection of Outcomes Data for Pregnant Patients With Cancer | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Study participants that are or were pregnant when diagnosed with cancer. |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Data Collection
Information about the type of cancer, type of treatment, and details about pregnancy will be collected. |
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| Study Group/Cohort (s) | Pregnant Patients with Cancer
Patients that are or were pregnant when diagnosed with cancer.
Intervention: Other: Data Collection |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2019 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: N/A |
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00507572 | ||||
| Other Study ID Numbers ICMJE | 2005-0518 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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