Clinical trial NCT03712566: Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy
Official title: Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Characterization of Genomic, epigenetic and Immune Profiling Features
timeFrame: Through study completion, up to 4 years
Secondary outcomes:
measure: Establish a Clinically Annotated Biorepository
timeFrame: Through study completion, up to 4 years
measure: Correlate Multi-Omic Results with Clinical Outcome
timeFrame: Through study completion, up to 4 years
measure: Compare HPV-Positive and HPV-Negative Cell Histologies
timeFrame: Through study completion, up to 4 years
measure: Investigate the Relationship Between Genomic Profiles and Radiomic Signatures
timeFrame: Through study completion, up to 4 years
measure: Enable Data-Sharing
timeFrame: Though study completion, up to 4 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Elena Elimova, MD
role: PRINCIPAL_INVESTIGATOR
References: