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| Name | Class |
|---|---|
| Regione Emilia-Romagna | OTHER |
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This is a biological study in patients with advanced Ewing Sarcoma who received, according, clinical practice, temozolomide and irinotecan The O6-methylguanine-DNA methyltransferase (MGMT) methylation status, will be correlated with the disease clinical data and with the disease response
This is a biological study in patients with advanced Ewing Sarcoma who received, according, clinical practice, temozolomide and irinotecan.
The MGMT methylation status will be correlated with the disease clinical data and with the disease response also in term of metabolic activity (if data will be available) The MGMT methylation analysis will be performed extracting from fresh tumor sample, the DNA on the basis of the standard protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temozolomide and Irinotecan treatment | The group include all the patients with histological confirmed diagnosis of Ewing's Sarcoma who received chemotherapic treatment with temozolomide and irinotecan. In this group the MGMT methylation evaluation will be done |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGMT methylation evaluation | Other | The MGMT methylation will be evaluated by extracting DNA from fresh and Formalin Fixed paraffin Embedded (FFPE) tumor samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of MGMT promoter methylation | Amplification the methylation-specific Polymerase Chain Reaction products will be electrophoresed on a 2% agarose gel and will visualized with UV light | at day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the MGMT promoter methylation to the activity of the temozolomide irinotecan combination | Correlation with level of MGMT methylation with tumor response | at month 2, 4, 6, 8, 10 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with advanced Ewing Sarcoma treated in clinic
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| Name | Affiliation | Role |
|---|---|---|
| Emanuela Palmerini, MD | Rizzoli Orthopedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Mi | 20133 | Italy | ||
| Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11157041 | Background | Kushner BH, Meyers PA. How effective is dose-intensive/myeloablative therapy against Ewing's sarcoma/primitive neuroectodermal tumor metastatic to bone or bone marrow? The Memorial Sloan-Kettering experience and a literature review. J Clin Oncol. 2001 Feb 1;19(3):870-80. doi: 10.1200/JCO.2001.19.3.870. | |
| 14581274 | Background |
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No Plan
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 7, 2014 | May 17, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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Fresh and Formaline Fixed Paraffin Embeded tumor samples
| Candiolo |
| Turin |
| 10060 |
| Italy |
| Orthopedic Rizzoli Institute | Bologna | 40136 | Italy |
| Ospedale infantile Regina Margherita | Turin | 10126 | Italy |
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| Bacci G, Ferrari S, Longhi A, Donati D, De Paolis M, Forni C, Versari M, Setola E, Briccoli A, Barbieri E. Therapy and survival after recurrence of Ewing's tumors: the Rizzoli experience in 195 patients treated with adjuvant and neoadjuvant chemotherapy from 1979 to 1997. Ann Oncol. 2003 Nov;14(11):1654-9. doi: 10.1093/annonc/mdg457. |
| 19637327 | Background | Casey DA, Wexler LH, Merchant MS, Chou AJ, Merola PR, Price AP, Meyers PA. Irinotecan and temozolomide for Ewing sarcoma: the Memorial Sloan-Kettering experience. Pediatr Blood Cancer. 2009 Dec;53(6):1029-34. doi: 10.1002/pbc.22206. |
| 16609952 | Background | Donson AM, Addo-Yobo SO, Handler MH, Gore L, Foreman NK. MGMT promoter methylation correlates with survival benefit and sensitivity to temozolomide in pediatric glioblastoma. Pediatr Blood Cancer. 2007 Apr;48(4):403-7. doi: 10.1002/pbc.20803. |
| 15758010 | Background | Hegi ME, Diserens AC, Gorlia T, Hamou MF, de Tribolet N, Weller M, Kros JM, Hainfellner JA, Mason W, Mariani L, Bromberg JE, Hau P, Mirimanoff RO, Cairncross JG, Janzer RC, Stupp R. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005 Mar 10;352(10):997-1003. doi: 10.1056/NEJMoa043331. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |