Esophageal CancerNCT02495337
Tissue Collection Protocol for Gastroesophageal Cancers
An observational study of Esophageal Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This proposed collection of primary tumor cells lines will benefit esophageal cancer research within the University Health Network. This collection of gastro-esophageal tumor samples will be used to grow primary tumor cell lines, which will provide researchers with ready samples of various gastro-esophageal cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Tissue Collection
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Dec 2030
- 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 esophagogastric cancer and/or GERD +/- Barrett's esophagus who will undergo surgery and/or EGD as standard of care.
Who may be able to join
- Patients with esophagogastric cancer and/or GERD +/- Barrett's esophagus who will undergo surgery and/or EGD as standard of care.
Who cannot join
- Patients who are not well enough to undergo surgery or EGD as standard of care.
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 General Hospital
Toronto, Ontario, M5G 2C4
Frances Allison, 416-340-5446, Frances.Allison@uhn.ca
Gail Darling, MD
About this study
Official title: Tissue Collection for Gastro-esophageal Cancer Primary Cell Line Establishment
This proposed collection of primary tumor cells lines will benefit esophageal cancer research within the University Health Network. This collection of gastro-esophageal tumor samples will be used to grow primary tumor cell lines, which will provide researchers with ready samples of various gastro-esophageal cancers. This will help to address the issue of access to these cell lines due to the limited number of patients with gastro-esophageal tumors, and high rates of contamination.
Read the detailed description
Samples will be collected during surgery, EGD, or other biopsy. The surgeon will resect a sample for the research coordinator and/or fellow who will collect the sample and take it back to the lab for processing. Samples collected will be in excess of standard samples that are sent for pathology. The surgeon will make sure that excess samples will not affect pathological diagnosis. In addition samples may be purchased from the National Cancer Institute's Cooperative Human Tissue Network.
- Conditions
- Esophageal Cancer
- Being tested
- Tissue Collection
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue CollectionOther
| Study group | Role | What they receive |
|---|---|---|
| TIssue Collection | Only one arm will be used to collect tissue from Esophageal Adenocarcinoma Receives: Other: Tissue Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectively culture, proliferate, and store primary gastro-esophageal cell lines in order to create a bank of primary esophageal / gastric cancers for research purposes
The primary objective of this study is to determine an effective way to culture, proliferate, and store primary gastro-esophageal cell lines in order to create a bank of primary esophageal / gastric cancers or GERD with/without Barrett's esophagus for research purposes, in addition we will be creating organoids.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Yeung, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495337
- Sponsor's protocol ID
- 14-8514
- Status last verified
- May 2025
- First submitted
- 27 May 2015
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- 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
- Tissue Collection for Gastro-esophageal Cancer Primary Cell Line Establishment
- ClinicalTrials.gov ID
- NCT02495337
- Acronym / sponsor ID
- 14-8514
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 13 Jul 2015 (estimated)
- 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.
This proposed collection of primary tumor cells lines will benefit esophageal cancer research within the University Health Network. This collection of gastro-esophageal tumor samples will be used to grow primary tumor cell lines, which will provide researchers with ready samples of various gastro-esophageal cancers. This will help to address the issue of access to these cell lines due to the limited number of patients with gastro-esophageal tumors, and high rates of contamination.
Detailed description
Samples will be collected during surgery, EGD, or other biopsy. The surgeon will resect a sample for the research coordinator and/or fellow who will collect the sample and take it back to the lab for processing. Samples collected will be in excess of standard samples that are sent for pathology. The surgeon will make sure that excess samples will not affect pathological diagnosis. In addition samples may be purchased from the National Cancer Institute's Cooperative Human Tissue Network.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIssue Collection | – | Other: Tissue CollectionOnly one arm will be used to collect tissue from Esophageal Adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophagogastric cancer and/or GERD +/- Barrett's esophagus who will undergo surgery and/or EGD as standard of care.
Key inclusion criteria (1 listed)
- Patients with esophagogastric cancer and/or GERD +/- Barrett's esophagus who will undergo surgery and/or EGD as standard of care.
Key exclusion criteria (1 listed)
- Patients who are not well enough to undergo surgery or EGD as standard of care.
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 |
|---|---|---|
| Tissue Collection | Other | TIssue Collection |
Primary outcome
Effectively culture, proliferate, and store primary gastro-esophageal cell lines in order to create a bank of primary esophageal / gastric cancers for research purposes
Time frame: Ongoing
The primary objective of this study is to determine an effective way to culture, proliferate, and store primary gastro-esophageal cell lines in order to create a bank of primary esophageal / gastric cancers or GERD with/without Barrett's esophagus for research purposes, in addition we will be creating organoids.
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.
Jonathan Yeung 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 Esophageal Cancer, 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 1 inclusion and 1 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?
Effectively culture, proliferate, and store primary gastro-esophageal cell lines in order to create a bank of primary esophageal / gastric cancers for research purposes (time frame: Ongoing). 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.