NCT01780961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

10.4 years

First QC Date

January 29, 2013

Last Update Submit

August 8, 2022

Conditions

Keywords

Esophageal CancerESBX

Outcome Measures

Primary Outcomes (1)

  • Prospective Database

    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.

    five years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Pediatric patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • Edwards FH. The STS database at 20 years: a tribute to Dr Richard E. Clark. Ann Thorac Surg. 2010 Jan;89(1):9-10. doi: 10.1016/j.athoracsur.2009.11.028. No abstract available.

    PMID: 20103196BACKGROUND
  • Ferguson TB Jr, Dziuban SW Jr, Edwards FH, Eiken MC, Shroyer AL, Pairolero PC, Anderson RP, Grover FL. The STS National Database: current changes and challenges for the new millennium. Committee to Establish a National Database in Cardiothoracic Surgery, The Society of Thoracic Surgeons. Ann Thorac Surg. 2000 Mar;69(3):680-91. doi: 10.1016/s0003-4975(99)01538-6.

    PMID: 10750744BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood and Esophageal Tissue

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2013

First Posted

January 31, 2013

Study Start

January 25, 2011

Primary Completion

June 30, 2021

Study Completion

October 29, 2021

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations