CancerMASSTNCT03712566
Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy
An observational study of Cancer and Esophagus Squamous Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Esophagus Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 6 Nov 2018to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
- Patients must be commencing on a new treatment at time of consent, this can be first line platinum based chemotherapy, or immunotherapy, any line.
- Patients must be ≥ 18 years old.
- Patients must have provided voluntary written informed consent.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cancer, Esophagus Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Anal Canal Squamous Cell Carcinoma, Metastatic Cancer
- Keywords
- Liquid Biopsy, Circulating Tumor DNA, Molecular Profiling, Immune Analysis, Epigenetics, Radiomics
- Medical subject headings
- Neoplasms, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 4 years
Secondary outcomes (5)
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.
Measured: Through study completion, up to 4 years
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.
Measured: Through study completion, up to 4 years
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.
Measured: Through study completion, up to 4 years
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.
Measured: Through study completion, up to 4 years
Enable Data-Sharing
To enable data sharing with Queen's University Belfast as a collaborative initiative based on this project
Measured: Though study completion, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start6 Nov 2018
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Elimova, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712566
- Sponsor's protocol ID
- MASST-001
- Acronym
- MASST
- Status last verified
- Jul 2026
- First submitted
- 16 Oct 2018
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy
- ClinicalTrials.gov ID
- NCT03712566
- Acronym / sponsor ID
- MASST / MASST-001
- Conditions
- Cancer, Esophagus Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Anal Canal Squamous Cell Carcinoma, Metastatic Cancer
- Keywords
- Liquid Biopsy, Circulating Tumor DNA, Molecular Profiling, Immune Analysis, Epigenetics, Radiomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- 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.
- Patients must be commencing on a new treatment at time of consent, this can be first line platinum based chemotherapy, or immunotherapy, any line.
- Patients must be ≥ 18 years old.
- Patients must have provided voluntary written informed consent.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Establish a Clinically Annotated Biorepository
Time frame: Through study completion, up to 4 years
Correlate Multi-Omic Results with Clinical Outcome
Time frame: Through study completion, up to 4 years
Compare HPV-Positive and HPV-Negative Cell Histologies
Time frame: Through study completion, up to 4 years
Investigate the Relationship Between Genomic Profiles and Radiomic Signatures
Time frame: Through study completion, up to 4 years
Enable Data-Sharing
Time frame: Though study completion, up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Elimova, MD principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Esophagus Squamous Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of Genomic, epigenetic and Immune Profiling Features (time frame: Through study completion, up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.