Squamous Cell Carcinomas of the Head and NeckHNSCCNCT01783158
Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma
An observational study of Squamous Cell Carcinomas of the Head and Neck, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Patients with HNSCC represent a high-risk group for the development of SESCC. Thus, esophagogastrofibroscopy should be performed to detect possible synchronous esophageal carcinomas in these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Squamous Cell Carcinomas of the Head and Neck
- What is being tested?
- Esophagoscopy and chromoendoscopy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 132 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2004to Dec 2012
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed head and neck carcinoma
Who may be able to join
- Newly diagnosed patients with head and neck carcinoma
- Age 18-65
Who cannot join
- Recurrent head and neck carcinomas
- Previously diagnosed oesophageal cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma in Patients With Squamous Cell Carcinomas of the Head and Neck?
Patients with HNSCC represent a high-risk group for the development of SESCC. Thus, esophagogastrofibroscopy should be performed to detect possible synchronous esophageal carcinomas in these patients.
Although only two patients with synchronous primary carcinomas were found among the patients with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced endoscopic methods should be recommended after detection of HNSCC to exclude secondary esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy and inexpensive option and can be done in most of gastroenterology offices.
Read the detailed description
ABSTRACT Objective: To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).
Methods: All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.
- Being tested
- Esophagoscopy and chromoendoscopy
- Keywords
- head and neck carcinoma, chromoendoscopy, Lugol's solution, esophageal carcinoma, synchronous tumors, deglutition, deglutition disorders, Newly diagnosed HNSCC
- Medical subject headings
- Esophageal Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagoscopy and chromoendoscopyProcedure or surgery
Esophagoscopy - examination of the interior of the esophagus by means of an esophagoscope.
Chromoendoscopy - a method, which involves the topical application of stains or pigments to improve tissue localization, characterization, or diagnosis during endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic group | A total of 132 patients with HNSCC were enrolled in this study. The patients underwent esophagoscopy and chromoendoscopy. The most frequent primary tumors were oropharyngeal (49/132), tumors of the oral cavity (36/132) and larynx (35/132). The majority of subjects (107/132 patients, 81.1%) had advanced HNSCC carcinomas (stages III and IV). Multiple LVLs were discovered in 24 subjects (18.2%), and no LVLs in 108 (81.8%) subjects. Fifty-five LVL biopsy specimens were obtained and assessed. Squamous cell carcinomas were detected in two patients, peptic esophagitis in 11 patients, gastric heterotopic mucosa in two patients, hyperplasia in two patients, and low- and high-grade dysplasia in three patients. Receives: Procedure: Esophagoscopy and chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect early synchronous second primary esophageal carcinoma
To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).
All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.
Measured: The primary measure was assessed immediately after the completion of the study by individual patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startJan 2004
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinomas of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel Kominek, MD, PhD, MSc, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783158
- Sponsor's protocol ID
- RVO-FNOs/2012
- Acronym
- HNSCC
- Status last verified
- Jan 2013
- First submitted
- 23 Jan 2013
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Muto M, Hironaka S, Nakane M, Boku N, Ohtsu A, Yoshida S. Association of multiple Lugol-voiding lesions with synchronous and metachronous esophageal squamous cell carcinoma in patients with head and neck cancer. Gastrointest Endosc. 2002 Oct;56(4):517-21. doi: 10.1067/mge.2002.128104.
PubMed 12297767SLAUGHTER DP, SOUTHWICK HW, SMEJKAL W. Field cancerization in oral stratified squamous epithelium; clinical implications of multicentric origin. Cancer. 1953 Sep;6(5):963-8. doi: 10.1002/1097-0142(195309)6:53.0.co;2-q. No abstract available.
PubMed 13094644Fukuhara T, Hiyama T, Tanaka S, Oka S, Yoshihara M, Arihiro K, Chayama K. Characteristics of esophageal squamous cell carcinomas and lugol-voiding lesions in patients with head and neck squamous cell carcinoma. J Clin Gastroenterol. 2010 Feb;44(2):e27-33. doi: 10.1097/MCG.0b013e3181b31325.
PubMed 19730116
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma in Patients With Squamous Cell Carcinomas of the Head and Neck?
- ClinicalTrials.gov ID
- NCT01783158
- Acronym / sponsor ID
- HNSCC / RVO-FNOs/2012
- Keywords
- head and neck carcinoma, chromoendoscopy, Lugol's solution, esophageal carcinoma, synchronous tumors, deglutition, deglutition disorders, Newly diagnosed HNSCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with HNSCC represent a high-risk group for the development of SESCC. Thus, esophagogastrofibroscopy should be performed to detect possible synchronous esophageal carcinomas in these patients.
Although only two patients with synchronous primary carcinomas were found among the patients with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced endoscopic methods should be recommended after detection of HNSCC to exclude secondary esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy and inexpensive option and can be done in most of gastroenterology offices.
Detailed description
ABSTRACT Objective: To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).
Methods: All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic group | – | Procedure: Esophagoscopy and chromoendoscopyA total of 132 patients with HNSCC were enrolled in this study. The patients underwent esophagoscopy and chromoendoscopy. The most frequent primary tumors were oropharyngeal (49/132), tumors of the oral cavity (36/132) and larynx (35/132). The majority of subjects (107/132 patients, 81.1%) had advanced HNSCC carcinomas (stages III and IV). Multiple LVLs were discovered in 24 subjects (18.2%), and no LVLs in 108 (81.8%) subjects. Fifty-five LVL biopsy specimens were obtained and assessed. Squamous cell carcinomas were detected in two patients, peptic esophagitis in 11 patients, gastric heterotopic mucosa in two patients, hyperplasia in two patients, and low- and high-grade dysplasia in three patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed head and neck carcinoma
Key inclusion criteria (2 listed)
- Newly diagnosed patients with head and neck carcinoma
- Age 18-65
Key exclusion criteria (2 listed)
- Recurrent head and neck carcinomas
- Previously diagnosed oesophageal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophagoscopy and chromoendoscopyEsophagoscopy - examination of the interior of the esophagus by means of an esophagoscope. Chromoendoscopy - a method, which involves the topical application of stains or pigments to improve tissue localization, characterization, or diagnosis during endoscopy. | Procedure or surgery | Diagnostic group |
Primary outcome
To detect early synchronous second primary esophageal carcinoma
Time frame: The primary measure was assessed immediately after the completion of the study by individual patients.
To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC). All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Background: PubMed 12297767Muto M, Hironaka S, Nakane M, Boku N, Ohtsu A, Yoshida S. Association of multiple Lugol-voiding lesions with synchronous and metachronous esophageal squamous cell carcinoma in patients with head and neck cancer. Gastrointest Endosc. 2002 Oct;56(4):517-21. doi: 10.1067/mge.2002.128104.
- Background: PubMed 13094644SLAUGHTER DP, SOUTHWICK HW, SMEJKAL W. Field cancerization in oral stratified squamous epithelium; clinical implications of multicentric origin. Cancer. 1953 Sep;6(5):963-8. doi: 10.1002/1097-0142(195309)6:53.0.co;2-q. No abstract available.
- Background: PubMed 19730116Fukuhara T, Hiyama T, Tanaka S, Oka S, Yoshihara M, Arihiro K, Chayama K. Characteristics of esophageal squamous cell carcinomas and lugol-voiding lesions in patients with head and neck squamous cell carcinoma. J Clin Gastroenterol. 2010 Feb;44(2):e27-33. doi: 10.1097/MCG.0b013e3181b31325.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Kominek, MD, PhD, MSc principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinomas of the Head and Neck, run by University Hospital Ostrava at 1 site in Czechia.
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 2 inclusion and 2 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 4 Feb 2013. 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 Czechia. 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?
To detect early synchronous second primary esophageal carcinoma (time frame: The primary measure was assessed immediately after the completion of the study by individual patients.). 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 NCT01783158, which also lists 3 linked publications.
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 4 Feb 2013.