NCT00587314

Brief Summary

To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation ) on Barrett's Esophagus

Trial Health

75
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress89%
Jan 2004Jan 2029

Study Start

First participant enrolled

January 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
21 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

25 years

First QC Date

December 21, 2007

Last Update Submit

March 9, 2026

Conditions

Barrett's EsophagusEarly Esophageal Adenocarcinoma

Keywords

Photodynamic TherapyBarrett's EsophagusEarly Esophageal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Response to treatment

    presence of persistent or recurrence of barrett's esophagus and/or dysplasia

    at time of surveillance intervals

Study Arms (1)

1

Patients with Barrett's Esophagus or early esophageal adenocarcinoma who will or have had ablation therapy will be enrolled in this long term follow up study

Other: Biopsy

Interventions

BiopsyOTHER

Biopsies for research purposes will be obtained when returning for clinically indicated surveillance of Barrett's Esophagus

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus

You may qualify if:

  • Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus with high grade dysplasia or early esophageal adenocarcinoma
  • Ability to provide informed consent

You may not qualify if:

  • Eastern Cooperative Oncology Group performance status 3 or 4
  • Inability to tolerate endoscopic procedures
  • Pregnancy: Females of child-bearing age will be screened with pregnancy test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Esophageal Biopsy

MeSH Terms

Conditions

Barrett EsophagusAdenocarcinoma Of Esophagus

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Cadman Leggett, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

January 1, 2004

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

US(1)