Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy

Active, not recruiting

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

• Registration Number: NCT03712566
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-19
• Study Start: 2018-11-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

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.

Read More

Exclusion Criteria

None

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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.

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada