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Esophageal Cancer Tissue Banking (ESBX)

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ClinicalTrials.gov Identifier: NCT01780961
Recruitment Status : Recruiting
First Posted : January 31, 2013
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
To create an esophageal cancer biospecimen repository that will collect, annotate, store and distribute human esophageal cancer biospecimens in a manner that embraces the highest ethical standards of human subject's research, that conforms to the best practices of biorepository science and that furthers basic, translational and clinical research in the understanding diagnosis and treatment of this disease.

Condition or disease
Esophageal Cancer

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective Collection of Health Information and Biospecimens in Esophageal Cancer
Study Start Date : January 2011
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Prospective Database [ Time Frame: five years ]
    A prospective database which would be maintained in the Division of Cardiothoracic Surgery would be able to link clinical outcomes to processed tissues (pathologic specimens, research specimens and plasma) enabling higher level correlation studies to be performed. Proper use of such a resource will aid considerably in our ability to advance our field and care for our future patients with esophageal cancer.


Biospecimen Retention:   Samples With DNA
peripheral blood and Esophageal Tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects will be identified by participating staff in the clinics of the surgical oncology or medical oncology clinics, and patients referred to the endoscopy center, and provided information about the biorepository.
Criteria

Inclusion Criteria:

  • Adults with known or suspected esophageal cancer who are willing and able to give written informed consent for biospecimen collections.
  • Age ≥ 18 years
  • Must be willing and able to sign an informed consent document

Exclusion Criteria:

  • Pediatric patients

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 ClinicalTrials.gov identifier (NCT number): NCT01780961


Contacts
Contact: Christine R Frederiksen, MS 314-362-2412 cfrederiksen@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Christine R Frederiksen, MS    314-362-2412    cfrederiksen@wustl.edu   
Principal Investigator: Varun Puri, MD         
Sponsors and Collaborators
Washington University School of Medicine

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01780961     History of Changes
Other Study ID Numbers: 201101765
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Keywords provided by Washington University School of Medicine:
Esophageal Cancer
ESBX

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases