NCT04665388 LANDscape MApping of Epitopes and T Cell Receptors for Selected Cancers
| NCT ID | NCT04665388 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Solid Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 105 participants |
| Start Date | 2020-11-30 |
| Primary Completion | 2026-02-28 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a correlative research project aimed at characterizing the T cell mediated immune responses to hepatocellular carcinoma (HCC), as well as Epstein-Barr virus (EBV)- and human papillomavirus (HPV)-related cancers. This study will enroll approximately 105 patients over 48 months. Of these 105 patients, 30 are EBV-related cancer, 45 are HPV-related cancer, and 30 are HCC. Patients will have blood samples collected one time to identify cancer specific T cells and T cell receptors in their blood. They will also have tissue samples collected one time to study the different types of immune cells, especially the T cells and their receptors. The 105 patients enrolled in this study will be compared to retrospective samples (N=210; 30 from EBV-related cancer cohort, 180 from HPV-related cancer cohort).
Eligibility Criteria
Inclusion Criteria: 1. Patients with a histological or cytological diagnosis of: 1. EBV-related malignancies (e.g. nasopharyngeal cancer) 2. HPV-related malignancies, including squamous cell carcinoma of the head and neck, cervix, vulva or anal canal. HPV positivity is required for squamous cell cancers of the head and neck.; p16 positivity as a surrogate for HPV testing is acceptable. HPV positivity is not required for cervix, vulva or anal canal cancer. * For cancers of the anal canal, late stage distant metastatic tumor tissue is preferred. However, early stage primary site tissue is acceptable, if the tissue can be procured without contamination by intestinal microbiota. 3. For HCC, only patients who have above UHN institutional upper limit of normal levels of alpha-fetoprotein (AFP) in serum will be eligible. The diagnosis of HCC should be made based on standard of care with or without tumor tissue confirmation. 2. Patients must be ≥ 18 years old. 3. Patients must have provided vo