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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02320-39 | Other Identifier | ID-RCB Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to evaluate the outcome (survival) of Adult T-cell leukemia / lymphoma (ATL) patients who receive or not specific treatment for their hemopathy (cohort 1) and the outcome (survival) of HTLV-1 chronically infected patients with / without extra-haematological disorders (cohort 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Adult T-cell leukemia / lymphoma (ATL) patients | ||
| 2 | HTLV-1 chronically infected patients without ATL |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of survivors | for cohorts 1 and 2 | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of survivors at 2 years | for cohorts 1 and 2 | At 2 years |
| Number of survivors at 5 years | for cohorts 1 and 2 | 5 years |
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Inclusion Criteria:
Exclusion Criteria
- Patients refusal of participation
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Adult patients with lymphoproliferation induced by HTLV-1 (or HTLV-1 adult T-cell lymphoma / leukemia) and HTLV-1 infected patients
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| Name | Affiliation | Role |
|---|---|---|
| Ambroise MARCAIS, MD | Assistance Publique-Hôpitaux Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker Enfants Malades | Paris | 75015 | France |
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whole blood, affected organ biopsy
| HTLV-1 proviral load | for cohorts 1 and 2 | day 1 |
| viral integration profile | for cohorts 1 and 2 | day 1 |
| lymphocyte phenotyping of tumor cells | for cohorts 1 and 2 | day 1 |
| genetic analysis of tumor cells by Next-generation sequencing (NGS) | for cohorts 1 and 2 | day 1 |
| number of patients with HTLV-1-related hematological disorders | for cohort 1 | day 1 |
| number of patients with HTLV-1-related extra-hematological disorders | for cohort 1 | day 1 |
| types of ATL | According the Shimoyama classification (smoldering, chronic, Acute and Lymphoma) for cohort 1 | day 1 |
| Treatment lines | Chemotherapy type, number of Chemotherapy cycles, efficacity of Chemotherapy : Number of complete remissions following treatment : for cohort 1 | during 5 years |
| Response to induction therapy | according to established response criteria for ATL for cohort 1 | during 5 years |
| Progression free survival (PFS) | for cohort 1 | during 5 years |
| relapse-related mortality | for cohort 1 | during 5 years |
| chemotherapy-related mortality | for cohort 1 | during 5 years |
| transplant-related mortality | for cohort 1 | during 5 years |
| Number of serious adverse events according to WHO classification related to treatment received | for cohort 1 | during 5 years |
| Allograft-specific characteristic | (donor type, conditioning type, engraftment, graft-related mortality) for cohort 1 | during 5 years |
| number of progression to ATL | at 2 years |
| Number of progression to ATL | At 5 years |
| number of patients with HTLV-1-related extrahematological disorders | during 5 years |
| Number of patients with corticotherapy for extrahematological complications | Dose of corticotherapy for extrahematological complications, number of days with corticotherapy for extrahematological complications | during 5 years |
| Number of Serious adverse events according to WHO classification related to treatment received | during 5 years |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015490 | HTLV-I Infections |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006800 | Deltaretrovirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
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