NCT03108898

Brief Summary

The purpose of this study is to better understand how esophageal cells change with age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

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

First Submitted

Initial submission to the registry

April 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 29, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
Last Updated

December 5, 2022

Status Verified

December 1, 2022

Enrollment Period

5.4 years

First QC Date

April 6, 2017

Last Update Submit

December 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Amount of Progenitor Cells

    We will examine sections of different portions of the esophagus, to determine whether certain sections contain more progenitors, and thus perhaps a greater ability to regenerate, than others.

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults undergoing esophageal surgery at Mayo Clinic Rochester

You may qualify if:

  • ≥ 18 years old
  • Esophagus surgery at Mayo Clinic

You may not qualify if:

  • \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 99509, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Esophageal tissue will be collected at the time of the patient's surgery in excess of clinical diagnosis (i.e. tissue that would otherwise be discarded). The researchers will analyze sections of adult esophagus tissue for the presence of CD34+ sox2+ progenitor cells to determine the number of progenitors present at a particular age of patient. The researchers will also examine sections of different portions of the esophagus, to determine whether certain sections contain more progenitors, and thus perhaps a greater ability to regenerate, than others.

MeSH Terms

Conditions

Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Dennis Wigle, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 11, 2017

Study Start

June 29, 2017

Primary Completion

November 22, 2022

Study Completion

November 22, 2022

Last Updated

December 5, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations