Evaluation for NCI Surgery Branch Clinical Studies
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | August 22, 2012 | ||||||||
| Start Date ICMJE | June 1999 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00001823 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 | Evaluation for NCI Surgery Branch Clinical Studies | ||||||||
| Official Title ICMJE | Evaluation for NCI Surgery Branch Clinical Research Protocols | ||||||||
| Brief Summary | Patients with a suspected or proven malignant disease (cancer) will be admitted to this study to be evaluated for suitability in a clinical trial of the National Cancer Institute's Surgery Branch. No experimental treatments will be administered in this study; its purpose is solely to evaluate patients for eligibility in other NCI Surgery Branch trials. In rare cases, patients who are ineligible for a current study may nevertheless be admitted for standard treatment because their condition represents a unique training or research experience. Patients will undergo various tests and procedures, depending on the study for which they are being considered. The tests may include, but not be limited to, various blood tests, such as HLA tissue typing and hepatitis screening; imaging tests such as PET, MRI and CT scans, and procedures such as pulmonary function tests, arteriogram, tumor biopsy, and laparoscopy. |
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| Detailed Description | Background: Potential research candidates undergo thorough screening including laboratory tests, scans, x-rays and review of pathology slides to determine initial eligibility for Surgery Branch research protocols. Objectives: To permit evaluation of patients referred to the NCI Surgery Branch in order to identify individuals who will be suitable candidates for Surgery Branch clinical research protocols. Eligibility: Patient suspected of having, or with biopsy proven malignant disease. Patient, parent or guardian (if a minor), is able to provide informed consent. Design: Patients enrolled on this protocol will be evaluated by NCI Surgery Branch physicians to determine the individual's suitability for participation in a clinical research protocol. An accrual ceiling of 5000 patients has been set to meet the screening needs of the Surgery Branch. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Not Provided | ||||||||
| Study Population | Not Provided | ||||||||
| Condition ICMJE | Cancer | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| 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 | 5000 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE |
Patients suspected of having, or with biopsy proven malignant disease. Patient, parent or guardian (if a minor), is able to provide informed consent. EXCLUSION CRITERIA: Candidates who do not meet the inclusion criteria. |
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| Gender | Both | ||||||||
| Ages | 16 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00001823 | ||||||||
| Other Study ID Numbers ICMJE | 990128, 99-C-0128 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | July 2012 | ||||||||
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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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