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

May 13, 2025 updated by: University Health Network, Toronto
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There will be two study arms:

  1. patients with suspected or diagnosed localized gastroesophageal adenocarcinoma (GEA) and
  2. patients diagnosed with de novo metastatic gastroesophageal adenocarcinoma. Fresh tumour, adjacent normal tissue materials, and blood samples will be acquired and utilized to generate molecular data. Stool or rectal swab samples will also be acquired for microbiome analysis. Physiologic, quality of life, epidemiologic, frailty, and other clinical data will be systematically collected as standard of care to serve as clinical correlates for the molecular data.

Arm 1 Primary Objectives

  1. Feasibility to produce a potential molecular signature in a clinically meaningful time point in patients with locally advanced GEA
  2. Study the molecular characteristics of GEA in patients with localized and resectable disease and identify predictive signatures of response to induction therapy and the development of novel treatment regimens
  3. To validate previously identified mutational signatures that defined subgroups of GEA

Arm 2 Primary Objectives

  1. Feasibility to produce a potential molecular signature in a clinically meaningful time point for patients with advanced GEA on 1st line chemotherapy
  2. Use of genotypes and genomic analyses to define therapies, and develop predictive and prognostic models
  3. Assess the feasibility of prospectively identifying distinct genomic characteristics which associate with response to systemic therapy and survival

STUDY ENDPOINTS:

  1. Feasibility of obtaining timely sequencing data (8-12 weeks) to guide treatment for patients progressing on 1st line treatment
  2. Feasibility of using ctDNA, metabolome, immune profiling and other emerging technologies to guide treatment
  3. Establish a program of personalized care for GEA patients in terms of pre-treatment assessment (Physiological and Frailty Risk Assessment, QOLQ, 4. Sarcopenia and Adiposity measurements) and treatment based on clinical-genomic correlations
  4. Establishment of repository of biospecimens (tumour, blood and microbiome)
  5. Establishment of robust preclinical models of GEA: PDO and PDX models
  6. Assess the feasibility of using PDO models to identify drug sensitivity to guide treatment decisions

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, LM5G2C4
        • Recruiting
        • University Health Network
        • Contact:
        • Principal Investigator:
          • Elena Elimova
        • Principal Investigator:
          • Gail E. Darling
        • Principal Investigator:
          • Jonathan CW Yeung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

Arm 1:

  • 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

Arm 2

  • Patients must have a histological or radiological diagnosis of advanced gastroesophageal cancer.
  • Patient must have a tumour lesion that is amenable to a core needle biopsy as judged by a staff radiologist. A minimum of 3 x 18G good quality tumour cores must be safely obtainable under CT or US guidance. Biopsy to be completed before systemic therapy begins.
  • Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied. See Section 13.1.3 for the evaluation of measurable disease. Patients with locally advanced gastroesophageal cancer with no metastatic disease who are not candidates for curative intent therapy as per part 1 of the protocol, are eligible for part 2 and are exempt from this criterion.
  • Patients must be fit enough to safely undergo a tumour biopsy as judged by the investigator.
  • Age ≥ 18 years.
  • Eastern Cooperative Group (ECOG) performance status 0-2
  • Life expectancy of greater than 90 days, as judged by the investigator.
  • Patients plan to undergo systemic treatment with platinum-based chemotherapy (e.g. FOLFOX, CF, CX with or without Herceptin) as first line standard systemic palliative treatment, or as part of a first line clinical trial.
  • Within 14 days of the proposed biopsy date, patients must have normal organ and marrow functions.

Exclusion Criteria:

Arm 1

  • 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.

Arm 2

  • 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.
  • Patients who are currently on anti-cancer treatment including chemotherapy for another malignancy.
  • Patients with known brain metastases are excluded from participation in this clinical study.
  • Patients with advanced gastroesophageal cancer who are going to be treated with non-platinum based chemotherapy in the first line setting.
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any condition that would, in the investigators' judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Localized Esophagogastric Adenocarcinoma
Patients diagnosed with gastroesophageal adenocarcinoma who will undergo surgical resection for curative intent, with or without neo-adjuvant chemotherapy or chemoradiotherapy.
Genetic: Molecular Profiling
This is a correlative study collecting biosamples to evaluate genomic characteristics and treatment outcomes of gastroesophageal adenocarcinoma.
Other Names:
  • Whole Genome Sequencing
Metastatic Esophagogastric Adenocarcinoma
Patients diagnosed with de novo metastatic gastroesophageal adenocarcinoma who will undergo platinum based first line chemotherapy.
Genetic: Molecular Profiling
This is a correlative study collecting biosamples to evaluate genomic characteristics and treatment outcomes of gastroesophageal adenocarcinoma.
Other Names:
  • Whole Genome Sequencing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
GEA sequencing data and molecular profiling
Time Frame: 2 years to recruit all patients
Feasibility of obtaining timely sequencing data to guide treatment for patients progressing on 1st line treatment.
2 years to recruit all patients
Establishment of GEA treatment algorithms
Time Frame: 2 years
Feasibility of using ctDNA, metabolome, immune profiling and other emerging technologies to guide treatment of GEA
2 years
Establishment of personalized GEA treatment protocols
Time Frame: 2 years
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.
2 years
GEA BioBank repository
Time Frame: 2 years
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.
2 years
GEA PDO and PDX models
Time Frame: 2 years
Establishment of robust patient derived tumour organoids (PDO) and Xenograft (PDX) models, and then assess feasibility of using models to identify drug sensitivity to guide treatment decisions.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elena Elimova, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-5663

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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