Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy (MASST)

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 Overview

• Status: Active, not recruiting
• Conditions: Cancer; Metastatic Cancer; Squamous Cell Carcinoma of the Head and Neck; Anal Canal Squamous Cell Carcinoma; Esophagus Squamous Cell Carcinoma

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of squamous cell cancer of the head & neck, esophagus, or anal canal who have radiologically confirmed recurrent or metastatic disease.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Elena Elimova, MD, Princess Margaret Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2018
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Liquid Biopsy; Epigenetics; Molecular Profiling; Circulating Tumor DNA; Radiomics; Immune Analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Esophageal Diseases; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Pathological Conditions, Signs and Symptoms; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: MASST-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No