Recruiting

Epitopes & T Cell Receptors

Sponsor:

University Health Network, Toronto

Code:

NCT04665388

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Solid Tumor

Study ID

NCT04665388

Start date

Nov 30, 2020

Status verified date

Jun, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 voluntary written informed consent.

Exclusion Criteria:

1\. Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimens and interpretation of study results.

Study Design

Enrollment

105 participants

Anticipated

Interventions and Outcome Measures

Arms

EBV-related cancer cohort

up to N=30

HPV-related cancer cohort

up to N=45

HCC cohort

up to N=30

Primary outcome measure

  • Identifying the p-HLA epitopes across diverse HLA alleles [ Time Frame: 63 months ]

Central Contacts and Locations

Central contacts

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Epstein-Barr Virus related cancer
  • Human Papilloma Virus related cancer
  • Hepatocellular Carcinoma
  • solid tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-09.