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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 18, 2007 | ||||
| Last Updated Date | September 14, 2009 | ||||
| Start Date ICMJE | May 2006 | ||||
| Estimated Primary Completion Date | May 2034 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To collect information regarding ovarian tumor of low malignant potential, a low-grade serous ovarian carcinoma, primary peritoneal tumor of low malignant potential, low-grade carcinoma of the peritoneum, or a psammocarcinoma. [ Time Frame: 28 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00488878 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To maintain patients' information in research database to learn and better understand about specific tumor types and to help develop better treatments for them. [ Time Frame: 28 Years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank. [ Time Frame: 28 Years ] [ Designated as safety issue: No ] | ||||
| 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 | Primary Objectives:
Secondary Objective: 1. To obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank. These samples will serve as the basis for future studies. |
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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 M. D. 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 M .D. Anderson medical record. However, information may also be requested from you, your local doctor, or an outside hospital. Information collected from sources other than M. D. Anderson will be included in your M. D. 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 M. D. 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 M. D. 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 M. D. Anderson. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Data Collection | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Completion Date | |||||
| 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 | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00488878 | ||||
| Responsible Party | David Gershenson, MD/Chair, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | 2006-0137 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | September 2009 | ||||
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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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