Upper Aerodigestive Tract LesionsTNFE-NBINCT01175499
Concordance of Two Endoscopic Procedures for Diagnosis of Carcinoma of the Upper Aerodigestive Tract
A study testing Direct Rigid Endoscopy and Transnasal Flexible Endoscopy with Narrowband Imaging in people with Upper Aerodigestive Tract Lesions and Neoplasms, Oropharyngeal, run by University of California, San Francisco.
Trial summary
This study will compare TNFE-NBI and biopsy, with DRE and biopsy for the diagnostic evaluation and staging of patients with suspicious UADT lesions. All patients enrolled in the study will undergo TNFE-NBI with biopsy of suspicious lesions prior to planned regular clinical care (DRE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Aerodigestive Tract Lesions, Neoplasms, Oropharyngeal, Oropharyngeal Cancer
- What is being tested?
- Direct Rigid Endoscopy and Transnasal Flexible Endoscopy with Narrowband Imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to not given
- 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
- Age eighteen years or older
- Patients who are pending operative direct laryngoscopy as standard clinical care
- Presence of upper aerodigestive tract (UADT) (oropharyngeal, hypopharyngeal and/or glottic mucosal) lesion(s) suspicious for diagnoses including but not limited to: squamous cell carcinoma, carcinoma in situ, squamous dysplasia, papilloma, OR presence of diagnosed metastatic squamous cell carcinoma in the neck with an unidentified primary lesion
- Ability to give written informed consent and willingness to comply with the requirements of the protocol
Who cannot join
- Patients who are not medically able to undergo TNFE
- Allergy to topical anesthesia
- Active lymphoma
- Lesion inaccessibility to TNFE: oral cavity (anterior 2/3 tongue, buccal mucosa)
- Coagulopathy: INR ≥ 1.5
- Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator such as anxiety or narrow nasal passage way.
About this study
Official title: Accuracy of Endoscopic Diagnosis of Carcinoma of the UpperAerodigestive Tract: A Tandem Trial of Direct Rigid Endoscopy and Transnasal Flexible Endoscopy With Narrowband Imaging
This study will compare TNFE-NBI and biopsy, with DRE and biopsy for the diagnostic evaluation and staging of patients with suspicious UADT lesions. All patients enrolled in the study will undergo TNFE-NBI with biopsy of suspicious lesions prior to planned regular clinical care (DRE). Biopsies will be evaluated by standard clinical methods for patient diagnoses and care. As the current standard of care, if all biopsies for a given patient are non-malignant, a 3 month office visit will be arranged to evaluate and determine the need for further intervention. At the end of study enrollment both sets of biopsies will be re-evaluated in a blinded fashion by the surgical pathologist. Study assessment of malignant vs. non-malignant (benign) pathology will be used to see whether both tests tended to agree on diagnoses.
Read the detailed description
This is a single arm prospective study to evaluate the concordance between a standard-of-care diagnostic procedure and TNFE-NBI for diagnosing malignancy. The primary aim of this investigation is to determine whether the TNFE NBI procedure can detect and stage cancer in the head and neck as well as the standard DRE which requires general anesthesia.
Patients who are pending direct laryngoscopy after presenting to the Department of Otolaryngology-Head and Neck Surgery at UCSF with UADT lesions will be asked to participate in the study provided all eligibility criteria are met. Under current standard-of-care for diagnostic evaluation and staging of UADT lesions, patients will undergo imaging studies including CT and/or MRI of the neck with contrast prior to direct laryngoscopy. Study participants will undergo both the TNFE NBI and DRE procedures.
The study procedure TNFE NBI will be performed, followed 1-6 weeks later by DRE, the standard approach for diagnosis, without the surgeon having knowledge of the details of the first procedure. The sequence of examinations in this investigation is dictated by the need to minimize mucosal trauma during the first examination and allow for mucosal healing prior to the second examination, and thus cannot be randomized. TNFE-NBI produces much less mucosal trauma by avoiding direct blunt manipulation and through the smaller, 1.8mm, cupped biopsy forceps.
Because it is possible that the TNFE NBI procedure might detect smaller tumors or lesions in different locations, the biopsy locations from the TNFE NBI procedure will be made known at the end of the DRE surgery to ensure that all needed areas are biopsied. Therefore, a secondary aim of this study will be to explore whether the TNFE NBI procedure may improve the detection of malignancy when added to the DRE surgery.
Patients enrolling in the study will undergo TNFE-NBI with biopsy of suspicious lesions. The TNFE-NBI examinations will be digitally recorded. The examiner will describe, using standard language and diagrams, anatomic location of suspicious areas revealed during the procedure. Biopsy tissue will be labeled as to the area of origin.
In the event that a participant does not tolerate TNFE-NBI, the study procedure will be aborted.
At least one week and no more than 6 weeks after TNFE-NBI, patients will undergo standard of care direct rigid endoscopy. The intervening time to DRE is to allow for recovery of mucosal surfaces.
Participants who did not tolerate TNFE-NBI will undergo DRE as standard of care.
The DRE examiner will be blinded as to which areas were biopsied during the TNFE-NBI procedure until completion of the standard of care DRE examination and tissue biopsy selection. In the investigator's experience, areas of prior biopsy will not be apparent to the DRE examiner as mucosal recovery will occur during 1-6 weeks elapsing between TNFE-NBI and DRE. Upon completion of the standard of care DRE examination and tissue biopsy selection, the DRE examiner will open the TNFE-NBI examiner's note describing the areas deemed suspicious during TNFE-NBI. Additional areas may then be examined and biopsied with DRE based on the TNFE-NBI note. Records will be kept as to which anatomic areas were:
- identified by both procedures,
- identified by DRE only after prompting by the TNFE-NBI note
- identified by DRE only (not previously identified by TNFE-NBI).
A diagnosis of carcinoma in situ or invasive squamous cell carcinoma will be considered positive for malignancy. If a diagnosis of malignancy is made after the initial endoscopy, regardless of which test was positive, the patient will be contacted immediately so that appropriate treatment can be pursued. For diagnoses of dysplasia and other non-malignant conditions such as polyp, lymphoid tissue, papilloma, etc., the patient will be scheduled for follow-up.
Routine follow-up of benign lesions includes a routine head and neck examination, including indirect laryngoscopy with a fiberoptic endoscope 2-3 months after biopsy. New or enlarging lesions will be assessed in the operating room with DRE per standard of care. Lesions initially diagnosed as non-malignant that are stable or not visualized at follow-up will not need re-biopsy per standard of care.
At the conclusion of study enrollment, all biopsy specimens will be de-identified, batched, and evaluated by a pathologist blinded to the type of endoscopy. A diagnosis of carcinoma in situ or invasive squamous cell carcinoma will be considered positive for malignancy.
If patients with non-malignant diagnoses of study pathology (both TNFE-NBI and DRE) have been diagnosed with malignancy at or before routine follow-up, the study evaluation will be considered a false negative. If no malignancy developed within three months of the biopsy procedures, the study evaluation will be considered a true negative. (This design represents a compromise in evaluating patients with a negative endoscopy. By necessity a negative diagnosis is one of exclusion, given that complete pathologic evaluation of every patients' upper aerodigestive tract is neither ethical, practical, nor feasible in clinical practice. Precedent for this design can be found in Smith-Bindman, Chu et al. 2005)
- Conditions
- Upper Aerodigestive Tract Lesions, Neoplasms, Oropharyngeal, Oropharyngeal Cancer, Neoplasms, Hypopharyngeal, Hypopharyngeal Cancer, Head and Neck Neoplasms
- Being tested
- Direct Rigid Endoscopy, Transnasal Flexible Endoscopy with Narrowband Imaging
- Keywords
- laryngoscopy, Laryngoscopic Surgery, laryngoscopes, upper aerodigestive tract lesions, endoscopy, biopsy
- Medical subject headings
- Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Papilloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Rigid EndoscopyDevice
Also called Rigid laryngoscope
Laryngoscopy is performed under general anesthesia with a rigid laryngoscope. Mucosal surfaces of the oropharynx, hypopharynx, and glottis (base of tongue, vallecula, epiglottis, aryepiglottic folds, arytenoids, piriform sinuses, true and false vocal cords, and esophageal inlet) are systematically visualized. Areas of irregularity are biopsied with 2mm and/or 4mm cupped forceps. Esophagoscopy and bronchoscopy will be performed per the standard of care.
Transnasal Flexible Endoscopy with Narrowband ImagingDevice
Also called EVIS EXERA 160A System
Transnasal flexible endoscopy with and without narrowband imaging- additional diagnostic test. This examination is performed after topical intranasal anesthesia with 2% Pontocaine spray. A fiberoptic laryngoscope is passed into the nasal cavity to the pharynx where mucosal surfaces of the UADT can be visualized. The optics of a standard fiberoptic scope are generally considered to be inferior to direct visualization. The addition of narrowband imaging does not change the procedure, but enhances visualization of the mucosal vasculature. Biopsies are performed through a second channel in the endoscope with 1.8mm cupped forceps and will require an additional dose of topical anesthesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between TNFE-NBI and DRE
At the conclusion of study enrollment, all biopsy specimens will be coded, de-identified, and re-evaluated by the study pathologist in a blinded fashion. The code will be broken for the purposes of study analyses.
If all biopsies taken by both procedures on each patient are diagnosed as non-malignant upon blinded evaluation by the study pathologist or if both procedures have at least one biopsy diagnosed as malignant, this will be considered concordance.
Measured: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed
Secondary outcomes (5)
Agreement of TNFE-NBI and DRE on tumor stage and location
Describe differences, if any, in characterization of AJCC cTNM stage and tumor location as determined by TNFE-NBI as compared to standard-of-care DRE
Measured: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed
Agreement between TNFE-NBI and DRE on biopsy location selection
describe differences, if any, in biopsy location during TNFE-NBI as compared to standard-of-care DRE
Measured: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed
False negative diagnoses by TNFE-NBI or DRE
To describe the frequency of detecting malignancy at a 3-month follow-up for patients initially diagnosed as negative for malignancy by both TNFE NBI and DRE evaluations
Measured: Approximately 4 months after enrollment, after completion of both procedures and 3-month follow-up for non-malignant diagnoses
Frequency and Timing of Adverse Events
The frequency by grade for all adverse events will be tabulated by type and procedure as well as timing (during or immediately following study procedure vs. follow-up).
Measured: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed and patient follow-up at 30 days
Describe patient tolerance for TNFE-NBI
Patients who have fulfilled the inclusion criteria and are unable to tolerate the unsedated examination will be classified as having non-concordance between TNFE-NBI and DRE (because a diagnosis could not be made based upon pathology) and the reason for intolerance to the procedure recorded.
Measured: At the time of TNFE-NBI procedure, study day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startJul 2010
Why it stopped: Unable to obtain funding to continue recruitment; no accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Aerodigestive Tract LesionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark S. Courey, MD, Principal investigator, UCSF Helen Diller Family Comprehensive Cancer Center, Otolaryngology, Head & Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175499
- Sponsor's protocol ID
- 10-00166
- Other IDs
- 10201
- Acronym
- TNFE-NBI
- Status last verified
- Aug 2014
- First submitted
- 20 Jul 2010
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Endoscopic Diagnosis of Carcinoma of the UpperAerodigestive Tract: A Tandem Trial of Direct Rigid Endoscopy and Transnasal Flexible Endoscopy With Narrowband Imaging
- ClinicalTrials.gov ID
- NCT01175499
- Acronym / sponsor ID
- TNFE-NBI / 10-00166
- Conditions
- Upper Aerodigestive Tract Lesions, Neoplasms, Oropharyngeal, Oropharyngeal Cancer, Neoplasms, Hypopharyngeal, Hypopharyngeal Cancer, Head and Neck Neoplasms
- Keywords
- laryngoscopy, Laryngoscopic Surgery, laryngoscopes, upper aerodigestive tract lesions, endoscopy, biopsy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain funding to continue recruitment; no accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2010
- First posted
- 4 Aug 2010 (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.
This study will compare TNFE-NBI and biopsy, with DRE and biopsy for the diagnostic evaluation and staging of patients with suspicious UADT lesions. All patients enrolled in the study will undergo TNFE-NBI with biopsy of suspicious lesions prior to planned regular clinical care (DRE). Biopsies will be evaluated by standard clinical methods for patient diagnoses and care. As the current standard of care, if all biopsies for a given patient are non-malignant, a 3 month office visit will be arranged to evaluate and determine the need for further intervention. At the end of study enrollment both sets of biopsies will be re-evaluated in a blinded fashion by the surgical pathologist. Study assessment of malignant vs. non-malignant (benign) pathology will be used to see whether both tests tended to agree on diagnoses.
Detailed description
This is a single arm prospective study to evaluate the concordance between a standard-of-care diagnostic procedure and TNFE-NBI for diagnosing malignancy. The primary aim of this investigation is to determine whether the TNFE NBI procedure can detect and stage cancer in the head and neck as well as the standard DRE which requires general anesthesia.
Patients who are pending direct laryngoscopy after presenting to the Department of Otolaryngology-Head and Neck Surgery at UCSF with UADT lesions will be asked to participate in the study provided all eligibility criteria are met. Under current standard-of-care for diagnostic evaluation and staging of UADT lesions, patients will undergo imaging studies including CT and/or MRI of the neck with contrast prior to direct laryngoscopy. Study participants will undergo both the TNFE NBI and DRE procedures.
The study procedure TNFE NBI will be performed, followed 1-6 weeks later by DRE, the standard approach for diagnosis, without the surgeon having knowledge of the details of the first procedure. The sequence of examinations in this investigation is dictated by the need to minimize mucosal trauma during the first examination and allow for mucosal healing prior to the second examination, and thus cannot be randomized. TNFE-NBI produces much less mucosal trauma by avoiding direct blunt manipulation and through the smaller, 1.8mm, cupped biopsy forceps.
Because it is possible that the TNFE NBI procedure might detect smaller tumors or lesions in different locations, the biopsy locations from the TNFE NBI procedure will be made known at the end of the DRE surgery to ensure that all needed areas are biopsied. Therefore, a secondary aim of this study will be to explore whether the TNFE NBI procedure may improve the detection of malignancy when added to the DRE surgery.
Patients enrolling in the study will undergo TNFE-NBI with biopsy of suspicious lesions. The TNFE-NBI examinations will be digitally recorded. The examiner will describe, using standard language and diagrams, anatomic location of suspicious areas revealed during the procedure. Biopsy tissue will be labeled as to the area of origin.
In the event that a participant does not tolerate TNFE-NBI, the study procedure will be aborted.
At least one week and no more than 6 weeks after TNFE-NBI, patients will undergo standard of care direct rigid endoscopy. The intervening time to DRE is to allow for recovery of mucosal surfaces.
Participants who did not tolerate TNFE-NBI will undergo DRE as standard of care.
The DRE examiner will be blinded as to which areas were biopsied during the TNFE-NBI procedure until completion of the standard of care DRE examination and tissue biopsy selection. In the investigator's experience, areas of prior biopsy will not be apparent to the DRE examiner as mucosal recovery will occur during 1-6 weeks elapsing between TNFE-NBI and DRE. Upon completion of the standard of care DRE examination and tissue biopsy selection, the DRE examiner will open the TNFE-NBI examiner's note describing the areas deemed suspicious during TNFE-NBI. Additional areas may then be examined and biopsied with DRE based on the TNFE-NBI note. Records will be kept as to which anatomic areas were:
- identified by both procedures,
- identified by DRE only after prompting by the TNFE-NBI note
- identified by DRE only (not previously identified by TNFE-NBI).
A diagnosis of carcinoma in situ or invasive squamous cell carcinoma will be considered positive for malignancy. If a diagnosis of malignancy is made after the initial endoscopy, regardless of which test was positive, the patient will be contacted immediately so that appropriate treatment can be pursued. For diagnoses of dysplasia and other non-malignant conditions such as polyp, lymphoid tissue, papilloma, etc., the patient will be scheduled for follow-up.
Routine follow-up of benign lesions includes a routine head and neck examination, including indirect laryngoscopy with a fiberoptic endoscope 2-3 months after biopsy. New or enlarging lesions will be assessed in the operating room with DRE per standard of care. Lesions initially diagnosed as non-malignant that are stable or not visualized at follow-up will not need re-biopsy per standard of care.
At the conclusion of study enrollment, all biopsy specimens will be de-identified, batched, and evaluated by a pathologist blinded to the type of endoscopy. A diagnosis of carcinoma in situ or invasive squamous cell carcinoma will be considered positive for malignancy.
If patients with non-malignant diagnoses of study pathology (both TNFE-NBI and DRE) have been diagnosed with malignancy at or before routine follow-up, the study evaluation will be considered a false negative. If no malignancy developed within three months of the biopsy procedures, the study evaluation will be considered a true negative. (This design represents a compromise in evaluating patients with a negative endoscopy. By necessity a negative diagnosis is one of exclusion, given that complete pathologic evaluation of every patients' upper aerodigestive tract is neither ethical, practical, nor feasible in clinical practice. Precedent for this design can be found in Smith-Bindman, Chu et al. 2005)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age eighteen years or older
- Patients who are pending operative direct laryngoscopy as standard clinical care
- Presence of upper aerodigestive tract (UADT) (oropharyngeal, hypopharyngeal and/or glottic mucosal) lesion(s) suspicious for diagnoses including but not limited to: squamous cell carcinoma, carcinoma in situ, squamous dysplasia, papilloma, OR presence of diagnosed metastatic squamous cell carcinoma in the neck with an unidentified primary lesion
- Ability to give written informed consent and willingness to comply with the requirements of the protocol
Key exclusion criteria (6 listed)
- Patients who are not medically able to undergo TNFE
- Allergy to topical anesthesia
- Active lymphoma
- Lesion inaccessibility to TNFE: oral cavity (anterior 2/3 tongue, buccal mucosa)
- Coagulopathy: INR ≥ 1.5
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 |
|---|---|---|
| Direct Rigid EndoscopyAlso: Rigid laryngoscopeLaryngoscopy is performed under general anesthesia with a rigid laryngoscope. Mucosal surfaces of the oropharynx, hypopharynx, and glottis (base of tongue, vallecula, epiglottis, aryepiglottic folds, arytenoids, piriform sinuses, true and false vocal cords, and esophageal inlet) are systematically visualized. Areas of irregularity are biopsied with 2mm and/or 4mm cupped forceps. Esophagoscopy and bronchoscopy will be performed per the standard of care. | Device | – |
| Transnasal Flexible Endoscopy with Narrowband ImagingAlso: EVIS EXERA 160A SystemTransnasal flexible endoscopy with and without narrowband imaging- additional diagnostic test. This examination is performed after topical intranasal anesthesia with 2% Pontocaine spray. A fiberoptic laryngoscope is passed into the nasal cavity to the pharynx where mucosal surfaces of the UADT can be visualized. The optics of a standard fiberoptic scope are generally considered to be inferior to direct visualization. The addition of narrowband imaging does not change the procedure, but enhances visualization of the mucosal vasculature. Biopsies are performed through a second channel in the endoscope with 1.8mm cupped forceps and will require an additional dose of topical anesthesia. | Device | – |
Primary outcome
Agreement between TNFE-NBI and DRE
Time frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed
At the conclusion of study enrollment, all biopsy specimens will be coded, de-identified, and re-evaluated by the study pathologist in a blinded fashion. The code will be broken for the purposes of study analyses. If all biopsies taken by both procedures on each patient are diagnosed as non-malignant upon blinded evaluation by the study pathologist or if both procedures have at least one biopsy diagnosed as malignant, this will be considered concordance.
5 secondary outcomes
Agreement of TNFE-NBI and DRE on tumor stage and location
Time frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed
Agreement between TNFE-NBI and DRE on biopsy location selection
Time frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed
False negative diagnoses by TNFE-NBI or DRE
Time frame: Approximately 4 months after enrollment, after completion of both procedures and 3-month follow-up for non-malignant diagnoses
Frequency and Timing of Adverse Events
Time frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed and patient follow-up at 30 days
Describe patient tolerance for TNFE-NBI
Time frame: At the time of TNFE-NBI procedure, study day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
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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.
Mark S. Courey, MD principal investigator
UCSF Helen Diller Family Comprehensive Cancer Center, Otolaryngology, Head & Neck Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Direct Rigid Endoscopy and Transnasal Flexible Endoscopy with Narrowband Imaging in people with Upper Aerodigestive Tract Lesions and Neoplasms, Oropharyngeal, run by University of California, San Francisco.
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 6 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: withdrawn, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Agreement between TNFE-NBI and DRE (time frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed). 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 Aug 2014.