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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03712566
Other study ID # MASST-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 6, 2018
Est. completion date December 2024

Study information

Verified date March 2024
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 39
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Princess Margaret Cancer Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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