NCT02435602

Brief Summary

This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol chromoendoscopy in the early detection of esophageal cancer in patients with prior head and neck cancers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

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

December 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

2.9 years

First QC Date

May 1, 2015

Last Update Submit

April 12, 2018

Conditions

Esophageal Squamous Cell CarcinomaSquamous Cell Carcinoma of the Head and Neck

Keywords

endoscopy, gastrointestinalcancer screening

Outcome Measures

Primary Outcomes (1)

  • Positive predictive value

    The results of two methods are compare regarding positive predictive value.

    2 years

Secondary Outcomes (2)

  • Duration of the esophagoscopy ( NBI versus Lugol staining)

    2 years

  • Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS)

    2 years

Study Arms (2)

NBI endoscopy

ACTIVE COMPARATOR

* GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy * Biopsy at the visually abnormal lesions * Pathologic examination of all biopsy tissue specimens * Advises of endoscopic/surgical or oncological treatment will be given to participants who will be diagnosed with ESCC or high grade dysplasia of the esophagus.

Procedure: NBI endoscopy

lugol chromoendoscopy

ACTIVE COMPARATOR

* GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy * Biopsy at the unstained lesions \>= 5 mm diameter * Pathologic examination of all biopsy tissue specimens * Advises of endoscopic/surgical or oncological treatment will be given to participants who will be diagnosed with ESCC or high grade dysplasia of the esophagus.

Procedure: Lugol chromoendoscopy

Interventions

NBI endoscopyPROCEDURE

GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions

NBI endoscopy
Lugol chromoendoscopyPROCEDURE

GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy Biopsy at the unstained lesions \>= 5 mm diameter Pathologic examination of all biopsy tissue specimens

lugol chromoendoscopy

Eligibility Criteria

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

You may qualify if:

  • Patients with past history ( \>= 1 year ) of head and neck cancer treated curatively and receiving regular follow - up at the outpatient clinic of the Head and Neck Department of Maria Skłodowska - Curie Memorial Cancer Center, Institiut of Oncology
  • years and older
  • Diagnosis of squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
  • Zubrod scale 0-2
  • Provided written informed consent

You may not qualify if:

  • Lack of written informed consent
  • Known allergy to iodine
  • Clinical conditions precluding upper GI endoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Sklodowska-curie Memorial Cancer Center, Institiute of Oncology

Warsaw, 02-781, Poland

Location

MeSH Terms

Conditions

Esophageal Squamous Cell CarcinomaSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Jaroslaw Regula, PhD

    Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland

    STUDY DIRECTOR

  • Anna Chaber-Ciopinska, MD

    Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2015

First Posted

May 6, 2015

Study Start

December 1, 2013

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

April 13, 2018

Record last verified: 2018-04

Locations

PL(1)