Squamous Cell CarcinomaNCT02943044
Quantitative Optical Sensor Findings in Head & Neck Squamous Cell Carcinoma
An observational study of Squamous Cell Carcinoma, run by Zenalux Biomedical, Inc. at 1 site in United States.
Trial summary
The goal of this study is to determine the optical spectroscopy characteristics of tumor in patients with head and neck squamous cell carcinoma (HNSCC). HNSCC constitutes over 90% of all head and neck cancers. Read more about this study
- Who is it for?
- Ages 24 to 89 years
- Conditions the study is for
- Squamous Cell Carcinoma
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2017
- 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 24 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients between the ages of 24 - 89 who are scheduled for routine panendoscopy and biopsy for suspected Head \& Neck Squamous Cell Carcinoma.
Who may be able to join
- Patients undergoing panendoscopy and biopsy for suspected squamous cell carcinoma of the head and neck.
- patient is > 24 to <89 years of age
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- < 24 years of age, >89 years of age
- Unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Amy Walker, 919-684-1732, amy.walker1@duke.edu
Walter Lee, MD
About this study
Official title: Characterization of Physiological and Morphological Features of Clinical Head & Neck Squamous Cell Carcinomas (HNSCCs) Using a Quantitative Optical Sensor
The goal of this study is to determine the optical spectroscopy characteristics of tumor in patients with head and neck squamous cell carcinoma (HNSCC). HNSCC constitutes over 90% of all head and neck cancers. These spectroscopy measurements will be compared with pathological diagnosis of tissue biopsies from the same site. These readings will be performed in the operating room during routine endoscopy with biopsy and tumor mapping of patients who have a suspected squamous cell carcinoma of the head and/or neck. Furthermore, a built in pressure sensor will be used to compare biopsy sites with their benign counterparts. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner. This would be especially helpful for clinic visits where suspicious lesions are seen and would otherwise require biopsy for diagnosis. Immediate benefits would include patients with unknown primaries in which numerous directed biopsies are obtained from multiple head and neck sites.
Read the detailed description
PURPOSE OF THE STUDY:
HYPOTHESES:
Noninvasive optical spectroscopic measurements of Head and Neck Squamous Cell Carcinoma (HNSCC) result in unique signatures that can differentiate between dysplasia, normal, other benign conditions as well as response to radiation therapy as assessed by clinical and histopathological methods.
STUDY OBJECTIVES
- Characterization of physiological and morphological features of clinical HNSCCs using a spectroscopy based quantitative optical sensor
- Evaluate the built-in pressure sensor of the probe as a means of making more measurements at a more consistent, narrower pressure range.
This device will be used to compare spectroscopy measurements with histopathological diagnoses. Subjects will undergo optical measurements at the time of routine biopsy for a suspected squamous cell carcinoma of the head and/or neck . Diffuse reflectance spectroscopy measurements from each lesion of clinical interest, as well as distant normal tissue. Three to five repeated scans will be obtained at each measured site. The clinical "tumor" site will then be biopsied. Samples will not be collected from normal tissue for biopsy. The results of the spectroscopy measurements are for research purposes only and will not be used to confirm a subject's diagnosis.
The optical spectrometer does not breach any skin defense barrier. As this study involves noninvasive optical measurements of tissues, no significant safety concerns are anticipated. The protocol measurements take less than one minute per site. The total amount of extended OR time is expected to be less than 5 minutes. No additional charges to the subject and/or insurance company is expected.
Qualitative analysis will be performed to describe whether there is correlation between spectroscopy measurements and pathologic diagnosis.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- No intervention, this is an observational study
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, this is an observational studyDevice
Non interventional, non-invasive measurements of tissue samples suspected of squamous cell carcinoma using an optical probe.
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical spectroscopic measurements of tumors in patients with HNSCC compared to the histopathologic diagnosis.
Measured: During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements
Secondary outcomes (2)
Optimal pressure levels of the optical probe
Measured: During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements
Added pressure sensing and self-calibration features of the optical probe improves specificity and sensitivity to differentiate HNSCC from their benign counterparts
Measured: During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zenalux Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Walter Lee, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943044
- Sponsor's protocol ID
- Pro00065967
- Other IDs
- 5R42CA156901-03
- Status last verified
- Mar 2017
- First submitted
- 21 Oct 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be de-identified prior to being shared outside of Duke.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Physiological and Morphological Features of Clinical Head & Neck Squamous Cell Carcinomas (HNSCCs) Using a Quantitative Optical Sensor
- ClinicalTrials.gov ID
- NCT02943044
- Acronym / sponsor ID
- Pro00065967
- Conditions
- Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zenalux Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke University, National Cancer Institute (NCI)
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Oct 2016 (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.
The goal of this study is to determine the optical spectroscopy characteristics of tumor in patients with head and neck squamous cell carcinoma (HNSCC). HNSCC constitutes over 90% of all head and neck cancers. These spectroscopy measurements will be compared with pathological diagnosis of tissue biopsies from the same site. These readings will be performed in the operating room during routine endoscopy with biopsy and tumor mapping of patients who have a suspected squamous cell carcinoma of the head and/or neck. Furthermore, a built in pressure sensor will be used to compare biopsy sites with their benign counterparts. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner. This would be especially helpful for clinic visits where suspicious lesions are seen and would otherwise require biopsy for diagnosis. Immediate benefits would include patients with unknown primaries in which numerous directed biopsies are obtained from multiple head and neck sites.
Detailed description
PURPOSE OF THE STUDY:
HYPOTHESES:
Noninvasive optical spectroscopic measurements of Head and Neck Squamous Cell Carcinoma (HNSCC) result in unique signatures that can differentiate between dysplasia, normal, other benign conditions as well as response to radiation therapy as assessed by clinical and histopathological methods.
STUDY OBJECTIVES
- Characterization of physiological and morphological features of clinical HNSCCs using a spectroscopy based quantitative optical sensor
- Evaluate the built-in pressure sensor of the probe as a means of making more measurements at a more consistent, narrower pressure range.
This device will be used to compare spectroscopy measurements with histopathological diagnoses. Subjects will undergo optical measurements at the time of routine biopsy for a suspected squamous cell carcinoma of the head and/or neck . Diffuse reflectance spectroscopy measurements from each lesion of clinical interest, as well as distant normal tissue. Three to five repeated scans will be obtained at each measured site. The clinical "tumor" site will then be biopsied. Samples will not be collected from normal tissue for biopsy. The results of the spectroscopy measurements are for research purposes only and will not be used to confirm a subject's diagnosis.
The optical spectrometer does not breach any skin defense barrier. As this study involves noninvasive optical measurements of tissues, no significant safety concerns are anticipated. The protocol measurements take less than one minute per site. The total amount of extended OR time is expected to be less than 5 minutes. No additional charges to the subject and/or insurance company is expected.
Qualitative analysis will be performed to describe whether there is correlation between spectroscopy measurements and pathologic diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients between the ages of 24 - 89 who are scheduled for routine panendoscopy and biopsy for suspected Head \& Neck Squamous Cell Carcinoma.
Key inclusion criteria (3 listed)
- Patients undergoing panendoscopy and biopsy for suspected squamous cell carcinoma of the head and neck.
- patient is > 24 to <89 years of age
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (2 listed)
- < 24 years of age, >89 years of age
- Unable to provide written informed consent.
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 |
|---|---|---|
| No intervention, this is an observational studyNon interventional, non-invasive measurements of tissue samples suspected of squamous cell carcinoma using an optical probe. | Device | – |
Primary outcome
Optical spectroscopic measurements of tumors in patients with HNSCC compared to the histopathologic diagnosis.
Time frame: During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements
2 secondary outcomes
Optimal pressure levels of the optical probe
Time frame: During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements
Added pressure sensing and self-calibration features of the optical probe improves specificity and sensitivity to differentiate HNSCC from their benign counterparts
Time frame: During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No. Data will be de-identified prior to being shared outside of Duke.
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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.
Walter Lee, MD principal investigator
Duke University
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 Carcinoma, run by Zenalux Biomedical, Inc. at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Mar 2017. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Walker (919-684-1732, amy.walker1@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical spectroscopic measurements of tumors in patients with HNSCC compared to the histopathologic diagnosis. (time frame: During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements). 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 3 Mar 2017.