Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy (MASST)
|ClinicalTrials.gov Identifier: NCT03712566|
Recruitment Status : Active, not recruiting
First Posted : October 19, 2018
Last Update Posted : January 7, 2020
|Condition or disease|
|Cancer Esophagus Squamous Cell Carcinoma Squamous Cell Carcinoma of the Head and Neck Anal Canal Squamous Cell Carcinoma Metastatic Cancer|
|Study Type :||Observational|
|Actual Enrollment :||39 participants|
|Official Title:||Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy|
|Actual Study Start Date :||November 6, 2018|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
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.
- Characterization of Genomic, epigenetic and Immune Profiling Features [ Time Frame: 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.
- Establish a Clinically Annotated Biorepository [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Though study completion, up to 4 years ]To enable data sharing with Queen's University Belfast as a collaborative initiative based on this project
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712566
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada|
|Principal Investigator:||Elena Elimova, MD||Princess Margaret Cancer Centre|