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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03712566

Collaborator

(none)

Enrollment

Location

46.8

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Esophagus Squamous Cell Carcinoma Squamous Cell Carcinoma of the Head and Neck Anal Canal Squamous Cell Carcinoma Metastatic Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

39 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy

Actual Study Start Date :

Nov 6, 2018

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Characterization of Genomic, epigenetic and Immune Profiling Features [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 Outcome Measures

Establish a Clinically Annotated Biorepository [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 [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 [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 [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 [Though study completion, up to 4 years]
To enable data sharing with Queen's University Belfast as a collaborative initiative based on this project

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.