Head and Neck CancerNCT00927446
Endoscopy Screening for Esophageal Cancer
An observational study of Head and Neck Cancer, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
Trial summary
Patients with head and neck cancer frequently develop synchronous or metachronous esophageal malignancies. Previous studies have demonstrated the efficacy of endoscopic screening for esophageal cancer in head and neck cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Endoscopy screening with narrow band imaging
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2009to Apr 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tissue diagnosis of head and neck carcinoma
Who may be able to join
- patients with tissue diagnosis of head and neck cancer
- histopathology of head and neck cancer is carcinoma (including squamous cell carcinoma, adenocarcinoma or undifferentiated)
- aged more than 18 years old
- agree to under go upper gastrointestinal endoscopy
Who cannot join
- lack of written informed consent
- the origin of head and neck cancer is metastatic
- histopathology of head and neck cancer is not carcinoma (e.g., sarcoma, lymphoma, etc)
- incomplete upper gastrointestinal endoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopy Screening for Esophageal Neoplasm With Narrow Band Imaging in Patients With Head and Neck Cancer: A Controlled Tandem Endoscopy Trial
Patients with head and neck cancer frequently develop synchronous or metachronous esophageal malignancies. Previous studies have demonstrated the efficacy of endoscopic screening for esophageal cancer in head and neck cancer patients. The Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions. However, whether the application of NBI improves the detection results have not been critically evaluated.
This study aims to investigate the diagnostic value of the NBI system in the endoscopic screening for esophageal neoplastic lesions in patients with head and neck cancer.
Read the detailed description
This is a prospective blinded controlled tandem endoscopy trial conducted in a regional medical center (Lotung Poh-Ai Hospital, Taiwan). Patients with tissue diagnosis of head and neck cancer are enrolled. Endoscopy screening for esophageal lesions is first performed by using the conventional white light system. Suspicious lesions are recorded. Then the entire esophagus is examined under the NBI system by another endoscopist, who is blinded to the result of the conventional endoscopy. After the endoscopic inspection completed, all suspicious lesions are biopsied. Before each procedure, which one of the two participating endoscopists applies the conventional or NBI system is randomized. The diagnostic rate of esophageal neoplasm by the conventional white light system and that of the NBI system are compared.
The endpoint is the neoplastic lesion detected on endoscopic biopsy. We considered invasive cancer, carcinoma in-situ, and high-grade dysplasia (which usually cannot be distinguished from carcinoma in situ) as the primary points. Any dysplastic lesions were considered as secondary points.
- Conditions
- Head and Neck Cancer
- Being tested
- Endoscopy screening with narrow band imaging
- Keywords
- esophageal cancer, head and neck cancer, narrow band imaging, endoscopy, screening
- Medical subject headings
- Head and Neck Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy screening with narrow band imagingProcedure or surgery
Also called NBI
Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy screening | Patients with tissue diagnosis of head and neck cancer undergo endoscopy screening with conventional white light system first. Then the entire esophagus is examined under the NBI system by another endoscopist, who is blinded to the result of the conventional endoscopy. Receives: Procedure: Endoscopy screening with narrow band imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological interpretation of biopsy specimen for invasive cancer, carcinoma in-situ, or high-grade dysplasia
Measured: Within 3 days of endoscopy examination
Secondary outcomes (1)
Pathological interpretation of biopsy specimen for any grade of dysplasia
Measured: within 3 days of endoscopy examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lotung Poh-Ai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tzeng-Huey Yang, M.D., Principal investigator, Lotung Poh-Ai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927446
- Sponsor's protocol ID
- OMCP-98-006
- Status last verified
- Oct 2010
- First submitted
- 22 Jun 2009
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopy Screening for Esophageal Neoplasm With Narrow Band Imaging in Patients With Head and Neck Cancer: A Controlled Tandem Endoscopy Trial
- ClinicalTrials.gov ID
- NCT00927446
- Acronym / sponsor ID
- OMCP-98-006
- Conditions
- Head and Neck Cancer
- Keywords
- esophageal cancer, head and neck cancer, narrow band imaging, endoscopy, screening
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lotung Poh-Ai HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 25 Jun 2009 (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 head and neck cancer frequently develop synchronous or metachronous esophageal malignancies. Previous studies have demonstrated the efficacy of endoscopic screening for esophageal cancer in head and neck cancer patients. The Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions. However, whether the application of NBI improves the detection results have not been critically evaluated.
This study aims to investigate the diagnostic value of the NBI system in the endoscopic screening for esophageal neoplastic lesions in patients with head and neck cancer.
Detailed description
This is a prospective blinded controlled tandem endoscopy trial conducted in a regional medical center (Lotung Poh-Ai Hospital, Taiwan). Patients with tissue diagnosis of head and neck cancer are enrolled. Endoscopy screening for esophageal lesions is first performed by using the conventional white light system. Suspicious lesions are recorded. Then the entire esophagus is examined under the NBI system by another endoscopist, who is blinded to the result of the conventional endoscopy. After the endoscopic inspection completed, all suspicious lesions are biopsied. Before each procedure, which one of the two participating endoscopists applies the conventional or NBI system is randomized. The diagnostic rate of esophageal neoplasm by the conventional white light system and that of the NBI system are compared.
The endpoint is the neoplastic lesion detected on endoscopic biopsy. We considered invasive cancer, carcinoma in-situ, and high-grade dysplasia (which usually cannot be distinguished from carcinoma in situ) as the primary points. Any dysplastic lesions were considered as secondary points.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopy screening | – | Procedure: Endoscopy screening with narrow band imagingPatients with tissue diagnosis of head and neck cancer undergo endoscopy screening with conventional white light system first. Then the entire esophagus is examined under the NBI system by another endoscopist, who is blinded to the result of the conventional endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tissue diagnosis of head and neck carcinoma
Key inclusion criteria (4 listed)
- patients with tissue diagnosis of head and neck cancer
- histopathology of head and neck cancer is carcinoma (including squamous cell carcinoma, adenocarcinoma or undifferentiated)
- aged more than 18 years old
- agree to under go upper gastrointestinal endoscopy
Key exclusion criteria (4 listed)
- lack of written informed consent
- the origin of head and neck cancer is metastatic
- histopathology of head and neck cancer is not carcinoma (e.g., sarcoma, lymphoma, etc)
- incomplete upper gastrointestinal endoscopy
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 |
|---|---|---|
| Endoscopy screening with narrow band imagingAlso: NBINarrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions. | Procedure or surgery | Endoscopy screening |
Primary outcome
Pathological interpretation of biopsy specimen for invasive cancer, carcinoma in-situ, or high-grade dysplasia
Time frame: Within 3 days of endoscopy examination
1 secondary outcome
Pathological interpretation of biopsy specimen for any grade of dysplasia
Time frame: within 3 days of endoscopy examination
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
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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.
Tzeng-Huey Yang, M.D. principal investigator
Lotung Poh-Ai Hospital
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 Head and Neck Cancer, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Oct 2010. 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 Taiwan. 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 was stopped early. Results are not available in the source record.
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?
Pathological interpretation of biopsy specimen for invasive cancer, carcinoma in-situ, or high-grade dysplasia (time frame: Within 3 days of endoscopy examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2010.