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Esophageal Squamous Cell CarcinomaNCT02435602

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

A study testing NBI endoscopy and Lugol chromoendoscopy in people with Esophageal Squamous Cell Carcinoma and Squamous Cell Carcinoma of the Head and Neck, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NBI endoscopy and Lugol chromoendoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
294 participants
Where
1 sitePoland
Study dates
Dec 2013to Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Maria Sklodowska-curie Memorial Cancer Center, Institiute of Oncology

    Warsaw, 02-781

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
NBI endoscopy, Lugol chromoendoscopy
Keywords
endoscopy, gastrointestinal, cancer screening
Medical subject headings
Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBI endoscopyProcedure or surgery

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

  • Lugol chromoendoscopyProcedure or surgery

    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 groups in NCT02435602
Study groupRoleWhat they receive
NBI endoscopyActive 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.
Receives: Procedure: NBI endoscopy
lugol chromoendoscopyActive 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.
Receives: Procedure: Lugol chromoendoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive predictive value

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

    Measured: 2 years

Secondary outcomes (2)

  1. Duration of the esophagoscopy ( NBI versus Lugol staining)

    Measured: 2 years

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2015 (estimated)
  2. Study startDec 2013
  3. Primary completionNov 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
294 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02435602
Sponsor's protocol ID
506-1-09-01-14
Status last verified
Apr 2018
First submitted
1 May 2015
Last updated
13 Apr 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing NBI endoscopy and Lugol chromoendoscopy in people with Esophageal Squamous Cell Carcinoma and Squamous Cell Carcinoma of the Head and Neck, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive predictive value (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02435602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.

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