Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2024

Arms, Groups and Cohorts

  • MASST
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Characterization of Genomic, epigenetic and Immune Profiling Features
    • Time Frame: Through study completion, up to 4 years
    • 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.

Secondary Measures

  • Establish a Clinically Annotated Biorepository
    • Time Frame: Through study completion, up to 4 years
    • 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.
  • Correlate Multi-Omic Results with Clinical Outcome
    • Time Frame: Through study completion, up to 4 years
    • To correlate genomic, othr-omic, radiomic and immune profiling results with clinical outcome – to identify potential predictive markers of response/resistance to systemic therapy.
  • Compare HPV-Positive and HPV-Negative Cell Histologies
    • Time Frame: Through study completion, up to 4 years
    • To compare HPV-positive and HPV-negative squamous cell histology across three disease sites with multi-omic assessment.
  • Investigate the Relationship Between Genomic Profiles and Radiomic Signatures
    • Time Frame: Through study completion, up to 4 years
    • To investigate whether any correlation or relation exists between tumor genomic profiles and radiomic imaging signatures.
  • Enable Data-Sharing
    • Time Frame: Though study completion, up to 4 years
    • To enable data sharing with Queen’s University Belfast as a collaborative initiative based on this project

Participating in This Clinical Trial

Inclusion Criteria

1. 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. 2. 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. 3. Patients must be commencing on a new treatment at time of consent, this can be first line platinum based chemotherapy, or immunotherapy, any line. 4. Patients must be ≥ 18 years old. 5. Patients must have provided voluntary written informed consent. Exclusion Criteria:

None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elena Elimova, MD, Principal Investigator, Princess Margaret Cancer Centre

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