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Tissue Collection Protocol for Gastroesophageal Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02495337
Recruitment Status : Recruiting
First Posted : July 13, 2015
Last Update Posted : April 29, 2021
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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. 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.

Samples will be collected during surgery or Esophagogastroduodenoscopy(EGD). 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

Condition or disease Intervention/treatment
Esophageal Cancer Other: Tissue Collection

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tissue Collection for Gastro-esophageal Cancer Primary Cell Line Establishment
Actual Study Start Date : May 2015
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
TIssue Collection
Only one arm will be used to collect tissue from Esophageal Adenocarcinoma
Other: Tissue Collection

Primary Outcome Measures :
  1. 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: 3 years ]

Biospecimen Retention:   Samples With DNA
Biopsy Samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with esophagogastric cancer and/or GERD +/- Barrett's esophagus who will undergo surgery and/or EGD as standard of care.

Inclusion Criteria:

  • Patients with esophagogastric cancer and/or GERD +/- Barrett's esophagus who will undergo surgery and/or EGD as standard of care.

Exclusion Criteria:

  • Patients who are not well enough to undergo surgery or EGD as standard of care.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02495337

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Contact: Frances Allison 416-340-5446

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Canada, Ontario
University Health Network: Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Frances Allison    416-340-5446   
Principal Investigator: Gail Darling, MD         
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Gail Darling University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT02495337    
Other Study ID Numbers: 14-8514
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases