Oral CancerNCT00507182
Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions
A study testing Fluorescence Spectroscopy in people with Oral Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to test a new way to look for cancer and pre-cancerous tissue changes inside the mouth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Fluorescence Spectroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 1999to 12 Jan 2018
- 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
- 1. Any person 18 years of age or older with a lesion of the oral mucosa. Persons with changes in existing lesions or those who develop new lesions can be re-evaluated, but it is not required.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Fluorescence and Reflectance Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions
The goal of this clinical research study is to test a new way to look for cancer and pre-cancerous tissue changes inside the mouth.
Read the detailed description
Abnormal-looking areas (lesions) inside the mouth may be a sign of cancer or changes that may lead to cancer. These lesions may need to be removed. Researchers are looking for a practical way to tell early on whether these lesions are cancer or may become cancer. This study will test a technique called fluorescence spectroscopy, which is under research in this study.
Each patient may have 1 to 5 lesions and several normal-looking areas inside the mouth exposed to a beam of light. The exposed tissues may emit very small amounts of light called fluorescence. This light is not seen by the eye but is detected by a computer. The small areas exposed to the light beam may then be removed.
The patients who need surgery may have the small tested areas removed when the lesions are surgically removed. A small sample from a normal-looking area may also be removed during surgery. Patients who do not need surgery may simply have small samples taken from the lesions and a normal-looking area in the clinic rather than in the operating room. The tissues will be looked at under a microscope to see whether they are cancerous. These results will be compared with the spectroscopy results.
If you are scheduled to participate in another MD Anderson study, Protocol 2008-0137 Entitled, "Phase Ib Study of Erlotinib Prior to Surgery in Patients with Head and Neck Cancer" (Study Chair: Dr. William William), some of your collected tissue samples may be shared with Dr. William for use on 2008-0137.
This is an investigational study. About 395 patients will be consented and screened for this study, with about 381 to take full part in this study. All will be treated at MD Anderson.
- Conditions
- Oral Cancer
- Being tested
- Fluorescence Spectroscopy
- Keywords
- Oral Mucosa Lesions, Oral Cancer, Neoplasia and Dysplasia in oral cavity mucosa, Fluorescence Spectroscopy, Reflectance Spectroscopy, Pre-cancerous lesions, Cancerous lesions, Mouth
- Medical subject headings
- Mouth Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence SpectroscopyProcedure or surgery
1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed.
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence Spectroscopy | Experimental | 1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed. Receives: Procedure: Fluorescence Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of Oral Lesions
Distinguishing between normal and abnormal sites with four lesion classifications of normal, non-malignant inflammatory, dysplasia, and neoplasia.
Measured: 11 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study start2 Jul 1999
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- None (open label)
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann M. Gillenwater, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507182
- Sponsor's protocol ID
- HNS99-100
- Other IDs
- NCI-2012-01601
- Status last verified
- Jan 2018
- First submitted
- 24 Jul 2007
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence and Reflectance Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions
- ClinicalTrials.gov ID
- NCT00507182
- Acronym / sponsor ID
- HNS99-100
- Conditions
- Oral Cancer
- Keywords
- Oral Mucosa Lesions, Oral Cancer, Neoplasia and Dysplasia in oral cavity mucosa, Fluorescence Spectroscopy, Reflectance Spectroscopy, Pre-cancerous lesions, Cancerous lesions, Mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Jul 1999 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 26 Jul 2007 (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 clinical research study is to test a new way to look for cancer and pre-cancerous tissue changes inside the mouth.
Detailed description
Abnormal-looking areas (lesions) inside the mouth may be a sign of cancer or changes that may lead to cancer. These lesions may need to be removed. Researchers are looking for a practical way to tell early on whether these lesions are cancer or may become cancer. This study will test a technique called fluorescence spectroscopy, which is under research in this study.
Each patient may have 1 to 5 lesions and several normal-looking areas inside the mouth exposed to a beam of light. The exposed tissues may emit very small amounts of light called fluorescence. This light is not seen by the eye but is detected by a computer. The small areas exposed to the light beam may then be removed.
The patients who need surgery may have the small tested areas removed when the lesions are surgically removed. A small sample from a normal-looking area may also be removed during surgery. Patients who do not need surgery may simply have small samples taken from the lesions and a normal-looking area in the clinic rather than in the operating room. The tissues will be looked at under a microscope to see whether they are cancerous. These results will be compared with the spectroscopy results.
If you are scheduled to participate in another MD Anderson study, Protocol 2008-0137 Entitled, "Phase Ib Study of Erlotinib Prior to Surgery in Patients with Head and Neck Cancer" (Study Chair: Dr. William William), some of your collected tissue samples may be shared with Dr. William for use on 2008-0137.
This is an investigational study. About 395 patients will be consented and screened for this study, with about 381 to take full part in this study. All will be treated at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescence Spectroscopy | Experimental | Procedure: Fluorescence Spectroscopy1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Any person 18 years of age or older with a lesion of the oral mucosa. Persons with changes in existing lesions or those who develop new lesions can be re-evaluated, but it is not required.
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Fluorescence Spectroscopy1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed. | Procedure or surgery | Fluorescence Spectroscopy |
Primary outcome
Classification of Oral Lesions
Time frame: 11 Years
Distinguishing between normal and abnormal sites with four lesion classifications of normal, non-malignant inflammatory, dysplasia, and neoplasia.
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 19 Jan 2018.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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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.
Ann M. Gillenwater, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescence Spectroscopy in people with Oral Cancer, run by M.D. Anderson Cancer Center 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 1 inclusion and 1 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 19 Jan 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 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?
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?
Classification of Oral Lesions (time frame: 11 Years). 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 Jan 2018.