Molecular Characteristics of Gastroesophageal Adenocarcinoma (MOCHA): A Prospective Feasibility Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

Researchers are looking to further our knowledge on disease biology and treatment selection for gastroesophageal adenocarcinoma. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients for the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with suspected or histologically confirmed localized gastroesophageal adenocarcinoma amenable to curative intent therapy with surgery as standard of care, either with or without induction chemotherapy or chemo radiotherapy.

Age ≥18 years.

Eastern Cooperative Group (ECOG) performance status 0-2

Patients must have a histological or radiological diagnosis of advanced gastroesophageal cancer.

Disqualifiers

Patients who are planned for definitive chemoradiation without surgical resection will be excluded from this study.

Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Patients with one or more contraindications to tumour biopsy according to UHN's standard biopsy procedures.

Patients who had prior systemic treatment for advanced or metastatic gastroesophageal cancer.

Trial population

Patients with suspected (Arm 1) or histologically confirmed gastroesophageal adenocarcinoma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Molecular Profiling

    Genetic

    This is a correlative study collecting biosamples to evaluate genomic characteristics and treatment outcomes of gastroesophageal adenocarcinoma.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Localized Esophagogastric Adenocarcinoma1 intervention
Group B: Metastatic Esophagogastric Adenocarcinoma1 intervention

Trial outcomes

Primary outcomes

1

GEA sequencing data and molecular profiling

Feasibility of obtaining timely sequencing data to guide treatment for patients progressing on 1st line treatment.

Time frame
2 years to recruit all patients
2

Establishment of GEA treatment algorithms

Feasibility of using ctDNA, metabolome, immune profiling and other emerging technologies to guide treatment of GEA

Time frame
2 years
3

Establishment of personalized GEA treatment protocols

Feasibility to establish a program of personalized care for GEA patients in terms of pre-treatment assessment (Physiological and Frailty Risk Assessment, QOLQ, Sarcopenia and Adiposity measurements) and treatment based on clinical-genomic correlations.

Time frame
2 years
4

GEA BioBank repository

Establishment of a repository of annotated, high quality blood, tumour and microbiome samples from patients with GEA. These archived specimens can be used in future research studies that aim to increase our understanding of GEA cancer and discover new ways of diagnosing and managing disease.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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