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The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435602
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Centre of Postgraduate Medical Education
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

Tracking Information
First Submitted Date  ICMJE May 1, 2015
First Posted Date  ICMJE May 6, 2015
Last Update Posted Date April 13, 2018
Actual Study Start Date  ICMJE December 2013
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
Positive predictive value [ Time Frame: 2 years ]
The results of two methods are compare regarding positive predictive value.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
  • Duration of the esophagoscopy ( NBI versus Lugol staining) [ Time Frame: 2 years ]
  • Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS) [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE
  • Esophageal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE
  • Procedure: NBI endoscopy
    GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions
  • Procedure: Lugol chromoendoscopy
    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
Study Arms  ICMJE
  • Active Comparator: NBI endoscopy
    • 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.
    Intervention: Procedure: NBI endoscopy
  • Active Comparator: lugol chromoendoscopy
    • 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.
    Intervention: Procedure: Lugol chromoendoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2018)
294
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2015)
300
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02435602
Other Study ID Numbers  ICMJE 506-1-09-01-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria Sklodowska-Curie Institute - Oncology Center
Study Sponsor  ICMJE Maria Sklodowska-Curie Institute - Oncology Center
Collaborators  ICMJE Centre of Postgraduate Medical Education
Investigators  ICMJE
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
PRS Account Maria Sklodowska-Curie Institute - Oncology Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP