Mapping immune responses in specific cancers
LANDscape MApping of Epitopes and T Cell Receptors for Selected Cancers
This study is trying to understand how the immune system responds to certain cancers by looking at blood and tissue samples from patients with liver cancer and cancers related to Epstein-Barr and HPV.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04665388 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize T cell mediated immune responses in patients with solid tumors, specifically focusing on hepatocellular carcinoma (HCC), Epstein-Barr virus (EBV)-related cancers, and human papillomavirus (HPV)-related cancers. Approximately 105 patients will be enrolled over 48 months, with blood and tissue samples collected to identify cancer-specific T cells and their receptors. The findings will be compared to retrospective samples to enhance understanding of immune responses in these cancers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of EBV-related malignancies, HPV-related malignancies, or hepatocellular carcinoma.
Not a fit: Patients without a histological or cytological diagnosis of the specified cancers or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved immunotherapy strategies for patients with specific types of cancer.
How similar studies have performed: Other studies have shown success in characterizing immune responses in cancer, making this approach promising but still requiring further validation.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Kathy Han, MD — Princess Margaret Cancer Centre
- Study coordinator: Kathy Han, MD
- Email: tip@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.