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Esophageal Cancer Tissue Banking (ESBX)

This study is currently recruiting participants.
Verified January 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01780961
First received: January 29, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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
Esophageal Cancer

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Prospective Database [ Time Frame: five years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 250
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780961

Contacts
Contact: Jasmine A Lewis, BSBA 314-362-4611 lewisja@wudosis.wustl.edu
Contact: Joanne F Musick, RN,BSN 314-747-0707 musickj@wudosis.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jasmine A Lewis, BSBA     314-362-4611     lewisja@wudosis.wustl.edu    
Contact: Joanne F Musick, BSN     314-747-0707     musickj@wudosis.wustl.edu    
Principal Investigator: Varun Puri, MD            
Sponsors and Collaborators
Washington University School of Medicine
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01780961     History of Changes
Other Study ID Numbers: 201101765
Study First Received: January 29, 2013
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013