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| Tracking Information | |||||
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| First Received Date ICMJE | January 15, 2008 | ||||
| Last Updated Date | October 30, 2009 | ||||
| Start Date ICMJE | November 2006 | ||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To prospectively collect data on chest CT screening for patients at increase lung-cancer risk after Hodgkin's disease. [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00601146 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease | ||||
| Official Title ICMJE | Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease | ||||
| Brief Summary | This research study is being done because patients with a history of chest radiation treatment for Hodgkin's disease have been shown to be at increased risk for developing lung cancer a number of years out from treatment. The risk appears to be further increased among patients with a smoking history. Currently, the practice is to recommend annual low-dose chest CT scans in survivors of Hodgkin's disease who have received prior chest radiation treatment and who have at least a moderate smoking history. In this study, the CT scans will be read and interpreted by the study radiologist, and the results recorded in a consistent manner. |
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| Detailed Description | - Participants will undergo a chest computed tomography (CT) scan once a year for a 3-year period. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE | Procedure: chest computed tomography scan | ||||
| 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 | 200 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00601146 | ||||
| Responsible Party | Andrea K. Ng, MD, Dana-Farber Cancer Institute/Brigham and Women's Hospital | ||||
| Study ID Numbers ICMJE | 06-122 | ||||
| Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||
| Collaborators ICMJE | Brigham and Women's Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Dana-Farber Cancer Institute | ||||
| Verification Date | October 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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