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Esophageal Cancer Tissue Banking (ESBX)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Washington University School of Medicine.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780961
First Posted: January 31, 2013
Last Update Posted: January 31, 2013
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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:


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

Primary Outcome Measures:
  • 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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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: 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
First Submitted: January 29, 2013
First Posted: January 31, 2013
Last Update Posted: January 31, 2013
Last Verified: January 2013

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