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

NCT04219137 | Recruiting

• 1 other identifier: 18-5663
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients for the future.

Conditions

Esophagogastric Adenocarcinoma

Outcome Measures

Primary Outcomes (5)

• GEA sequencing data and molecular profiling

  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

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

  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.

  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.

  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.

  2 years

Study Arms (2)

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

Metastatic Esophagogastric Adenocarcinoma

Patients diagnosed with de novo metastatic gastroesophageal adenocarcinoma who will undergo platinum based first line chemotherapy.

Genetic: Molecular Profiling

Interventions

Molecular Profiling GENETIC

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

Also known as: Whole Genome Sequencing

Localized Esophagogastric Adenocarcinoma; Metastatic Esophagogastric Adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, LM5G2C4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumour and blood samples will be collected for molecular characterization. Microbiome samples will also be collected for analysis.

MeSH Terms

Interventions

Whole Genome Sequencing

Intervention Hierarchy (Ancestors)

Sequence Analysis, DNA; Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• Elena Elimova

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frances Allison

CONTACT

416-340-5446; Frances.Allison@uhn.ca

Yvonne Bach

CONTACT

416-340-5446; Yvonne.Bach2@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: January 6, 2020
• Study Start: November 14, 2019
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CA (1)