Data Collection for Patients With Low Grade Ovarian Carcinoma
| Tracking Information | |||||
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| First Received Date ICMJE | June 18, 2007 | ||||
| Last Updated Date | March 15, 2013 | ||||
| Start Date ICMJE | May 2006 | ||||
| Estimated Primary Completion Date | May 2034 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Data Collection for Patients with Low Grade Ovarian Carcinoma [ Time Frame: 28 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00488878 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 | Data Collection for Patients With Low Grade Ovarian Carcinoma | ||||
| Official Title ICMJE | Data Collection for Patients With Low Grade Ovarian Carcinoma | ||||
| Brief Summary | The goal of this psychosocial research study is to collect information on patients with one of the above-mentioned low-grade tumors. Researchers want to maintain these patients' information in a research database to help learn and better understand these tumor types and to help develop better treatments for them. |
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| Detailed Description | Low-grade tumors of female organs are considered rare. Because of this, doctors do not know the best treatment for these kinds of tumors. Researchers want to learn more about patients' experience with these types of cancer to help find ways to develop better therapies to treat them. If you agree to take part in this study, information about your type of cancer, the type of treatment you had or are having, and details about your follow-up care will be entered into a research database. These data will be collected from patients seen at MD Anderson since January, 1950. This information will serve as a basis for research studies about patients with low-grade ovarian tumors. Your data will mostly come from your MD Anderson medical record. However, information may also be requested from you, your local doctor, or an outside hospital. Information collected from sources other than MD Anderson will be included in your MD Anderson medical record as well as entered into this study's database. Information may be directly collected from you, if there are additional questions not provided in your medical records, if your information is not complete, or if your information collected from other sources does not match what is in your MD Anderson medical record. To help ensure confidentiality, the database will be password-protected with access strictly limited to study staff. This research database will be updated at least once a year to include information about your current treatment and/or follow-up care. This information is usually collected from your MD Anderson medical record, or it may be necessary to contact you directly. This information will be collected indefinitely. If you wish to end your participation in this study, you may request that your data remain in the database or that your information be deleted from the database. This is an investigational study. Up to 1,000 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: Cohort | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: If patient gives consent, tumor tissue left over from earlier surgery or surgeries that is preserved in wax or on glass slides will be stored in a research tissue bank. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Department of Gynecologic Oncology or the Department of Gynecologic Medical Oncology at UT MD Anderson Cancer Center in Houston, Texas |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Data Collection
Data collection from ovarian cancer patients seen at M.D. Anderson since January, 1950. |
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| Study Group/Cohort (s) | Ovarian Cancer Data Collection
Intervention: Behavioral: 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 | 1000 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | May 2034 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: None |
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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 | NCT00488878 | ||||
| Other Study ID Numbers ICMJE | 2006-0137 | ||||
| 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 | March 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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