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| Name | Class |
|---|---|
| University of Manchester | OTHER |
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This study will explore the ability of patients on first line combination immunotherapy to sample cytokines at home. The data from this study will be used to evaluate the feasibility of in-home testing and the ability to analyse patients cytokine profiles retrospectively to help feed the development of further studies.
Patients will be informed of the study and given a minimum of 24 hours to consider. Once consented patients will enter the study where they will take cytokine samples at home over a 12 week period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This is an observational study |
| Measure | Description | Time Frame |
|---|---|---|
| Patient adherence to protocol defined DBS time points. | the number of DBS samples successfully collected against the number of total expected samples | 12 months |
| Number of in-home DBS samples passing quality assurance checks in patients receiving CPI therapy by multi-cytokine ELISA. | the number of DBS samples passing quality assurance checks against the number of DBS samples successfully collected. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare cytokine concentrations by DBS sampling and intravenous blood sampling by multi-cytokine ELISA. | The changes of cytokine concentrations will be estimated by the log-ratio of cytokine concentrations measured at two time points. The trend of cytokine concentration during treatment will be estimated by fitting a linear regression model based on all cytokine concentrations collected during treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective mapping of immune-related adverse events with cytokine concentrations over time by in-home DBS sampling. | The association between these statistics and the development of immune-related adverse events will be estimated using a logistic regression analysis. | 12 months |
| Patient reported outcomes from semi-structured interviews. |
Inclusion Criteria:
Exclusion Criteria:
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Patients receiving checkpoint inhibitor therapy as first line treatment of renal cell carcinoma, metastatic melanoma or non-small cell lung cancer (in combination with chemotherapy for NSCLC).
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| Name | Affiliation | Role |
|---|---|---|
| Donna Graham, MD | The Christie NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Christie NHS Foundation Trust | Manchester | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 22, 2026 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008545 | Melanoma |
| D002292 | Carcinoma, Renal Cell |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Plasma.
| 12 months |
The patient satisfaction level will be assessed by survey interviews. |
| 12 months |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |