PET-CT in AML for Detection of Extramedullary AML Manifestations (PETAML)
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| First Received Date ICMJE | January 14, 2011 | ||||||||
| Last Updated Date | March 7, 2011 | ||||||||
| Start Date ICMJE | February 2011 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01278069 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 | PET-CT in AML for Detection of Extramedullary AML Manifestations | ||||||||
| Official Title ICMJE | PET-AML - Value of 18FDG-PET-CT in Patients With AML for Detection of Extramedullary AML Manifestations | ||||||||
| Brief Summary | Myeloid Sarcoma (or granulocytic Sarcoma or Chloroma) is well defined by the WHO. However, there are currently no data about the prevalence, sites of occurence and thr prognostic value for patients with AML with this finding. Information about this condition is based on retrospective analyses since there have been no studies trying to define the role of myeloid sarcoma in AML so far. This observational trial will include adult patients with newly diagnosed and relapsed AML in order to perform 18FDG-PET-CT imaging prior to induction chemotherapy. Furthermore, a second 18FDG-PET-CT will be performed after induction chemotherapy to define the responsiveness of these tumors to chemotherapy. The primary endpoint of this study is the prevalence of 18FDG-PET-CT positive extramedullary AML manifestations (myeloid sarcoma) in patients with newly diagnosed or relapsed AML. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Inpatients or Outpatients with newly diagnosed or relapsed AML AML |
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| Condition ICMJE | Newly Diagnosed or Relapsed Acute Myeloid Leukemia | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Stölzel F, Röllig C, Radke J, Mohr B, Platzbecker U, Bornhäuser M, Paulus T, Ehninger G, Zöphel K, Schaich M. ¹?F-FDG-PET/CT for detection of extramedullary acute myeloid leukemia. Haematologica. 2011 Oct;96(10):1552-6. Epub 2011 Jun 17. | ||||||||
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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 | 93 | ||||||||
| Estimated Completion Date | May 2015 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01278069 | ||||||||
| Other Study ID Numbers ICMJE | TUD-PETAML-043 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Friedrich Stölzel, M.D., Medizinische Fakultät Carl Gustav Carus Dresden, Technical University Dresden | ||||||||
| Study Sponsor ICMJE | Dresden University of Technology | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Dresden University of Technology | ||||||||
| Verification Date | January 2011 | ||||||||
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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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