Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT04219137

Conditions

Esophagogastric Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Molecular Profiling

Study Details

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

Study ID

NCT04219137

Start date

Nov 14, 2019

Status verified date

May, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Localized Esophagogastric Adenocarcinoma

Patients diagnosed with gastroesophageal adenocarcinoma who will undergo surgical resection for curative intent, with or without neo-adjuvant chemotherapy or chemoradiotherapy.

Metastatic Esophagogastric Adenocarcinoma

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

Interventions

Molecular Profiling

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

Primary outcome measure

  • GEA sequencing data and molecular profiling [ Time Frame: 2 years to recruit all patients ]
  • Establishment of GEA treatment algorithms [ Time Frame: 2 years ]
  • Establishment of personalized GEA treatment protocols [ Time Frame: 2 years ]
  • GEA BioBank repository [ Time Frame: 2 years ]
  • GEA PDO and PDX models [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Frances Allison

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

Yvonne Bach

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

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, LM5G2C4

Contacts

Elena Elimova

416-946-4501Elena.Elimova@uhn.ca

Principal Investigator:

Elena Elimova

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 14, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-05-14.