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Active, Not Recruiting

NCT Number: NCT03712566

Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Anal Canal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Esophagus Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of the Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: MASST

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Oct 19, 2018
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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