Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy

Study Overview
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Brief Summary
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This is prospective research study which will include patients with recurrent or metastatic squamous cell carcinoma of the head and neck, esophagus and anal canal starting on first-line platinum based chemotherapy or any line of immunotherapy treatment.This study aims to characterize the dynamic changes in genomic, epigenetic, immune profiling and imaging data during treatment with systemic therapy. Patients will have archived tumor samples requested as well as blood samples collected at up to four time points to analyze these changes. Imaging data will be derived from patients' routine CT scans before and after treatment.

Official Title
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Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy

Conditions
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Cancer, Esophagus Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Anal Canal Squamous Cell Carcinoma, Metastatic Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a histological or cytological diagnosis of Squamous Cell Cancer of the head and neck, esophagus or anal canal who have radiologically confirmed recurrent or metastatic disease. Patients must be of adequate fitness, ECOG 0-1 for systemic therapy, with either standard chemotherapy, immunotherapy or within the context of a clinical trial. Patients must be commencing on a new treatment at time of consent, this can be first line platinum based chemotherapy, or immunotherapy, any line. Patients must be ≥ 18 years old. Patients must have provided voluntary written informed consent. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MASST<br>Patients with a histological or cytological confirmed diagnosis of Squamous Cell Cancer of the Head & Neck, Esophagus or Anal Canal who have radiologically confirmed recurrent or metastatic disease and are commencing on a new treatment or either first-line platinum based chemotherapy or any line immunotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of Genomic, epigenetic and Immune Profiling Features | To comprehensively characterize genomic, epigenetic and immune profiling features and changes in longitudinal blood samples that are associated with systemic treatment of recurrent or metastatic squamous cell cancers of the head & neck, esophagus and anal canal. | Through study completion, up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish a Clinically Annotated Biorepository | To establish a clinically annotated biorepository of archived tumor and longitudinal blood samples, with serial radiomic evaluations in patients with recurrent/metastatic squamous cell cancers commencing on any new systemic treatments. | Through study completion, up to 4 years | 
| Correlate Multi-Omic Results with Clinical Outcome | To correlate genomic, othr-omic, radiomic and immune profiling results with clinical outcome - to identify potential predictive markers of response/resistance to systemic therapy. | Through study completion, up to 4 years | 
| Compare HPV-Positive and HPV-Negative Cell Histologies | To compare HPV-positive and HPV-negative squamous cell histology across three disease sites with multi-omic assessment. | Through study completion, up to 4 years | 
| Investigate the Relationship Between Genomic Profiles and Radiomic Signatures | To investigate whether any correlation or relation exists between tumor genomic profiles and radiomic imaging signatures. | Through study completion, up to 4 years | 
| Enable Data-Sharing | To enable data sharing with Queen's University Belfast as a collaborative initiative based on this project | Though study completion, up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liquid Biopsy, Circulating Tumor DNA, Molecular Profiling, Immune Analysis, Epigenetics, Radiomics