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| ID | Type | Description | Link |
|---|---|---|---|
| 20-5803 | Other Identifier | CAPCR ID |
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| Name | Class |
|---|---|
| Princess Margaret Hospital, Canada | OTHER |
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This study aims to study the kinetics of ctDNA levels after the first dose of immune checkpoint inhibitor in patients with recurrent or metastatic head and neck cancer. This is an important study to understand the optimal timing for ctDNA quantitation for future studies in immunotherapy, though further validation would be needed in other tumor types. It may help standardize the most relevant blood collection time points so that patients will not be subjected to multiple blood draws at random time points in future liquid biopsy trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IO-KIN | Patients with a histological or cytological confirmed recurrent, metastatic or advanced HNSCC of the oral cavity, oropharynx, hypopharynx, larynx or unknown origin (but being treated as HNSCC). Patients who are going to receive at least one dose of anti-PD1 antibody (nivolumab or pembrolizumab). |
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| Measure | Description | Time Frame |
|---|---|---|
| The change in kinetics of ctDNA changes in advanced/metastatic will be measured for HNSCC patients treated with immune checkpoint inhibitors (anti-PD-1 antibody). | At each time-point, absolute ctDNA levels will be calculated from all test targets (including undetected targets).The change in ctDNA from baseline to every time-point is defined as the percentage change in absolute ctDNA levels in plasma at that end point since baseline. | Through study completion, up to 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in ctDNA levels will be measured. These value will help correlate with progression free survival (PFS) and overall survival (OS). | At each time-point, absolute ctDNA levels will be calculated from all test targets (including undetected targets).The change in ctDNA from baseline to every time-point is defined as the percentage change in absolute ctDNA levels in plasma at that end point since baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a diagnosis of advanced/metastatic head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx or unknown origin (but being treated as HNSCC) and are receiving at least one dose of nivolumab or pembrolizumab.
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| Name | Affiliation | Role |
|---|---|---|
| Lillian Siu | Princess Margaret Cancer Centre | Principal Investigator |
| Scott Bratman | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
Targeted gene sequencing results, along with limited clinical information that does not identify the patient as an individual, such as age, partial date of birth (year, month), gender, cancer type, and pathology information related to the samples tested, and survival time may be shared with collaborating researchers.
Data from this study can be shared through two types of databases: open-access or controlled-access. An open-access database is publicly accessible and contains limited clinical information and analyses of samples. A controlled-access database contains more detailed clinical information, such as relevant past medical history and the results of prior and ongoing cancer treatments, and analyses of samples, but is only accessible to researchers who sign agreements defining how data may be used. All data will be stripped of all personal identifying information.
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009362 | Neoplasm Metastasis |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
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Blood samples collected serially for cfDNA and gDNA extraction. Archived tumor sample collected for tumor genomic DNA analysis.
| Through study completion, up to 1.5 years |
| The optimal time-point will be measured to analyze ctDNA as a predictive marker of response to immune checkpoint inhibitors (anti-PD-1 antibody). | At each time-point, absolute ctDNA levels will be calculated from all test targets (including undetected targets).The change in ctDNA from baseline to every time-point is defined as the percentage change in absolute ctDNA levels in plasma at that end point since baseline. | Through study completion, up to 1.5 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |