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

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ClinicalTrials.gov Identifier: NCT03712566
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Cancer Esophagus Squamous Cell Carcinoma Squamous Cell Carcinoma of the Head and Neck Anal Canal Squamous Cell Carcinoma Metastatic Cancer

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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
Peripheral blood samples collected serially for DNA extraction under the LIBERATE protocol. Archived tumor samples collected for DNA extraction.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of squamous cell cancer of the head & neck, esophagus, or anal canal who have radiologically confirmed recurrent or metastatic disease.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712566


Contacts
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Contact: Celeste Yu 416-946-4501 ext 5281 celeste.yu@uhn.ca
Contact: Samanta Del Rossi 416-946-4501 ext 2642 samanta.delrossi@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Celeste Yu    416-946-4501 ext 5281      
Principal Investigator: Elena Elimova, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Elena Elimova, MD Princess Margaret Cancer Centre

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03712566     History of Changes
Other Study ID Numbers: MASST-001
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:
Liquid Biopsy
Circulating Tumor DNA
Molecular Profiling
Immune Analysis
Epigenetics
Radiomics

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasm Metastasis
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Head and Neck Neoplasms
Neoplasms by Site
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases