Esophagogastric AdenocarcinomaMOCHANCT04219137
Molecular Characteristics of Gastroesophageal Adenocarcinoma (MOCHA): A Prospective Feasibility Study
An observational study of Esophagogastric Adenocarcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagogastric Adenocarcinoma
- What is being tested?
- Molecular Profiling
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 14 Nov 2019to Nov 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 suspected (Arm 1) or histologically confirmed gastroesophageal adenocarcinoma
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, LM5G2C4
Elena Elimova, 416-946-4501 ext. 2520, Elena.Elimova@uhn.ca
Elena Elimova
About this study
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.
Read the detailed description
There will be two study arms:
- patients with suspected or diagnosed localized gastroesophageal adenocarcinoma (GEA) and
- 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
- Feasibility to produce a potential molecular signature in a clinically meaningful time point in patients with locally advanced GEA
- 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
- To validate previously identified mutational signatures that defined subgroups of GEA
Arm 2 Primary Objectives
- Feasibility to produce a potential molecular signature in a clinically meaningful time point for patients with advanced GEA on 1st line chemotherapy
- Use of genotypes and genomic analyses to define therapies, and develop predictive and prognostic models
- Assess the feasibility of prospectively identifying distinct genomic characteristics which associate with response to systemic therapy and survival
STUDY ENDPOINTS:
- Feasibility of obtaining timely sequencing data (8-12 weeks) to guide treatment for patients progressing on 1st line treatment
- Feasibility of using ctDNA, metabolome, immune profiling and other emerging technologies to guide treatment
- 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
- Establishment of repository of biospecimens (tumour, blood and microbiome)
- Establishment of robust preclinical models of GEA: PDO and PDX models
- Assess the feasibility of using PDO models to identify drug sensitivity to guide treatment decisions
- Conditions
- Esophagogastric Adenocarcinoma
- Being tested
- Molecular Profiling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular ProfilingGenetic
Also called Whole Genome Sequencing
This is a correlative study collecting biosamples to evaluate genomic characteristics and treatment outcomes of gastroesophageal adenocarcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Localized Esophagogastric Adenocarcinoma | Patients diagnosed with gastroesophageal adenocarcinoma who will undergo surgical resection for curative intent, with or without neo-adjuvant chemotherapy or chemoradiotherapy. Receives: Genetic: Molecular Profiling | |
| Metastatic Esophagogastric Adenocarcinoma | Patients diagnosed with de novo metastatic gastroesophageal adenocarcinoma who will undergo platinum based first line chemotherapy. Receives: Genetic: Molecular Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
GEA sequencing data and molecular profiling
Feasibility of obtaining timely sequencing data to guide treatment for patients progressing on 1st line treatment.
Measured: 2 years to recruit all patients
Establishment of GEA treatment algorithms
Feasibility of using ctDNA, metabolome, immune profiling and other emerging technologies to guide treatment of GEA
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
GEA PDO and PDX models
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start14 Nov 2019
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric AdenocarcinomaStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Elimova, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219137
- Sponsor's protocol ID
- 18-5663
- Acronym
- MOCHA
- Status last verified
- May 2025
- First submitted
- 10 Dec 2019
- Last updated
- 14 May 2025
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characteristics of Gastroesophageal Adenocarcinoma (MOCHA): A Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT04219137
- Acronym / sponsor ID
- MOCHA / 18-5663
- Conditions
- Esophagogastric Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 6 Jan 2020 (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.
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.
Detailed description
There will be two study arms:
- patients with suspected or diagnosed localized gastroesophageal adenocarcinoma (GEA) and
- 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
- Feasibility to produce a potential molecular signature in a clinically meaningful time point in patients with locally advanced GEA
- 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
- To validate previously identified mutational signatures that defined subgroups of GEA
Arm 2 Primary Objectives
- Feasibility to produce a potential molecular signature in a clinically meaningful time point for patients with advanced GEA on 1st line chemotherapy
- Use of genotypes and genomic analyses to define therapies, and develop predictive and prognostic models
- Assess the feasibility of prospectively identifying distinct genomic characteristics which associate with response to systemic therapy and survival
STUDY ENDPOINTS:
- Feasibility of obtaining timely sequencing data (8-12 weeks) to guide treatment for patients progressing on 1st line treatment
- Feasibility of using ctDNA, metabolome, immune profiling and other emerging technologies to guide treatment
- 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
- Establishment of repository of biospecimens (tumour, blood and microbiome)
- Establishment of robust preclinical models of GEA: PDO and PDX models
- Assess the feasibility of using PDO models to identify drug sensitivity to guide treatment decisions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Localized Esophagogastric Adenocarcinoma | – | Genetic: Molecular ProfilingPatients diagnosed with gastroesophageal adenocarcinoma who will undergo surgical resection for curative intent, with or without neo-adjuvant chemotherapy or chemoradiotherapy. |
| Metastatic Esophagogastric Adenocarcinoma | – | Genetic: Molecular ProfilingPatients diagnosed with de novo metastatic gastroesophageal adenocarcinoma who will undergo platinum based first line chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected (Arm 1) or histologically confirmed gastroesophageal adenocarcinoma
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular ProfilingAlso: Whole Genome SequencingThis is a correlative study collecting biosamples to evaluate genomic characteristics and treatment outcomes of gastroesophageal adenocarcinoma. | Genetic | Localized Esophagogastric Adenocarcinoma, Metastatic Esophagogastric Adenocarcinoma |
Primary outcome
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.
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
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.
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.
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.
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 May 2025.
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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.
Elena Elimova principal investigator
University Health Network, Toronto
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 Esophagogastric Adenocarcinoma, 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 14 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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?
Contact Frances Allison (416-340-5446, Frances.Allison@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GEA sequencing data and molecular profiling (time frame: 2 years to recruit all patients). The study lists 5 primary outcomes in all. 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 May 2025.