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The study will evaluate the detection of tumor-antigen specific immune cells in cancer patients in whom the role of the immune system is suspected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| first type, called "A" Cohorts | Experimental | The first type, called "A" Cohorts, corresponds to indications for which the treatment induces a high response rate (>30%). These patients will have a lymphapheresis before and during treatment with immunotherapy. In addition, a blood sample in CellSave® tubes (15mL) will be taken at baseline and three weeks, and EDTA tubes (15mL) will be taken at baseline, 3 weeks after treatment start and at progression. |
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| second type, called "B" Cohorts | Experimental | The second type, called "B" Cohorts, corresponds to indications for which a role of the immune system is suspected. Only the so-called "informative" patients (responders or surprising evolution) will have one lymphapheresis during treatment. The lymphapheresis will be performed between 8 weeks and 18 months after the start of treatment and depending on the clinical course determined by the clinicians in consultation with at least one immunologist (Olivier Lantz, Emanuela Romano, Marion Alcantara). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample | Other | lymphapheresis before and during treatment, blood sample in CellSave® tubes (15mL) will be taken at baseline and three weeks, and EDTA tubes (15mL) will be taken at baseline, 3 weeks after treatment start and at progression |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the presence of tumor-antigen specific T cells for Cohorts A | Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. | before treatment |
| Evaluation of the presence of tumor-antigen specific T cells for Cohorts A | Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. | During treatment |
| Evaluation of the presence of tumor-antigen specific T cells for Cohorts A | Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. | at baseline |
| Evaluation of the presence of tumor-antigen specific T cells for Cohorts A | Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. | 3 weeks after treatment start |
| Evaluation of the presence of tumor-antigen specific T cells for Cohorts A | Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. | at progression (up to 100 weeks) |
| Evaluation of the presence of tumor-antigen specific T cells for Cohorts B | Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. | between 8 weeks and 18 months after the start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cyrine EZZILI, PhD | Contact | 0033147111657 | cyrine.ezzili@curie.fr | |
| Fouzia AZZOUZ | Contact | fouzia.azzouz@curie.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie | Recruiting | Paris | 75005 | France |
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| blood sample | Other | lymphapheresis will be performed between 8 weeks and 18 months after the start of treatment |
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| Institut Curie | Recruiting | Saint-Cloud | 92210 | France |
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| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |