Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy

Cancer Clinical Trial

— MASST  

Official title:

Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03712566
• Other study ID #: MASST-001
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Anal Canal Squamous Cell Carcinoma
• Cancer
• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Esophagus Squamous Cell Carcinoma
• Metastatic Cancer
• Neoplasms, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

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