Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy

NCT03712566 | Active Not Recruiting

• 1 other identifier: MASST-001
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Liquid Biopsy; Circulating Tumor DNA; Molecular Profiling; Immune Analysis; Epigenetics; Radiomics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Establish a Clinically Annotated Biorepository

  Through study completion, up to 4 years

• Correlate Multi-Omic Results with Clinical Outcome

  Through study completion, up to 4 years

• Compare HPV-Positive and HPV-Negative Cell Histologies

  Through study completion, up to 4 years

• Investigate the Relationship Between Genomic Profiles and Radiomic Signatures

  Through study completion, up to 4 years

• Enable Data-Sharing

  Though study completion, up to 4 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples collected serially for DNA extraction under the LIBERATE protocol. Archived tumor samples collected for DNA extraction.

MeSH Terms

Conditions

Neoplasms; Esophageal Squamous Cell Carcinoma; Squamous Cell Carcinoma of Head and Neck; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elena Elimova, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 19, 2018
• Study Start: November 6, 2018
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CA (1)