- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02435602
The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers
April 12, 2018 updated by: Maria Sklodowska-Curie National Research Institute of Oncology
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: a Prospective Randomized Study
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Patients with head and neck cancers have an increased risk for developing an esophageal squamous cell carcinoma (ESCC).
Small, superficial, curable lesions are difficult to diagnose using only white light endoscopy.
To improve detection chromoendoscopy is recommended.
In this project patients are divided into two groups based on received chromoendoscopy (NBI versus Lugol).
The results of two methods will be compare regarding positive predictive value to establish usage of chromoendoscopy in early detection of ESCC.
Study Type
Interventional
Enrollment (Actual)
294
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Warsaw, Poland, 02-781
- Maria Sklodowska-curie Memorial Cancer Center, Institiute of Oncology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 18 years and older
- Diagnosis of squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
- Zubrod scale 0-2
- Provided written informed consent
Exclusion Criteria:
- Lack of written informed consent
- Known allergy to iodine
- Clinical conditions precluding upper GI endoscopy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: NBI endoscopy
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GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions
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Active Comparator: lugol chromoendoscopy
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive predictive value
Time Frame: 2 years
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The results of two methods are compare regarding positive predictive value.
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2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of the esophagoscopy ( NBI versus Lugol staining)
Time Frame: 2 years
|
2 years
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Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS)
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Jaroslaw Regula, PhD, Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland
- Principal Investigator: Anna Chaber-Ciopinska, MD, Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2013
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
May 1, 2015
First Submitted That Met QC Criteria
May 5, 2015
First Posted (Estimate)
May 6, 2015
Study Record Updates
Last Update Posted (Actual)
April 13, 2018
Last Update Submitted That Met QC Criteria
April 12, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
Other Study ID Numbers
- 506-1-09-01-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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