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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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Immunotherapies have substantially improved the prognosis of patients with haematological malignancies. While clinical trial data suggest durable complete response rates, markers associated with non-response to treatment are still poorly described. The identification of predictive markers using demographic, physiologic, biologic, immunologic data as well as patients' treatment history, might enable the optimization of therapeutic sequences and the reduction of treatment toxicity.
This study aim to assess markers of toxicity and response following an immunotherapy in patients with a haematological malignancy using real life data.
It will allow the development of clinical and therapeutic benchmarks to guide medical decisions in relation to the therapeutic strategies to be implemented for patients benefiting from real-life conditions, in addition to the results obtained in randomized studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with a haematological malignancy treated with immunotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Data collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of complete response | Treatment response : Explore the proportion of complete response | Through study completion, an average of 1 year |
| Proportion of partial response | Treatment response : Explore the proportion of partial response | Through study completion, an average of 1 year |
| Proportion of stable disease | Treatment response : Explore the proportion of stable disease | Through study completion, an average of 1 year |
| Proportion of progress disease | Treatment response : Explore the proportion of progress disease | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade III adverse events | Toxicity : Explore the cumulative incidence of grade III and IV adverse events | Through study completion, an average of 1 year |
| Incidence of grade IV adverse events |
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Inclusion Criteria :
Exclusion Criteria :
- Patients opposed to the collection of their personnal data
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Adult patients diagnosed with a haematological malignancy and treated with immunotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Jeremie Zerbit, PharmD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital | Paris | Île-de-France Region | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37627056 | Result | Detroit M, Collier M, Beeker N, Willems L, Decroocq J, Deau-Fischer B, Vignon M, Birsen R, Moufle F, Leclaire C, Balladur E, Deschamps P, Chauchet A, Batista R, Limat S, Treluyer JM, Ricard L, Stocker N, Hermine O, Choquet S, Morel V, Metz C, Bouscary D, Kroemer M, Zerbit J. Predictive Factors of Response to Immunotherapy in Lymphomas: A Multicentre Clinical Data Warehouse Study (PRONOSTIM). Cancers (Basel). 2023 Aug 9;15(16):4028. doi: 10.3390/cancers15164028. |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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Toxicity : Explore the cumulative incidence of grade III and IV adverse events
| Through study completion, an average of 1 year |
| Interruption rates of immunotherapy | Toxicity : Explore the interruption and discontinuation rates of immunotherapy | Through study completion, an average of 1 year |
| Discontinuation rates of immunotherapy | Toxicity : Explore the interruption and discontinuation rates of immunotherapy | Through study completion, an average of 1 year |
| Time interval between the date of initiation treatment and the date of first progression | Progression free survival | Through study completion, an average of 1 year |
| Time interval between the date of initiation treatment and the date of death from any cause | Overall survival | Through study completion, an average of 1 year |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |