Oral CancerNCT01531881
Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression
An observational study of Oral Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This research may help dentists or surgeons to better detect areas in the mouth that are either prone to cancer or are early cancers. The earlier the detection on cancer in the mouth, the better the chance that treatment or prevention can be more effective. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Oral Cancer
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jan 2014
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dental clinic patients
Who may be able to join
- Patients with a history of suspicious lesions or currant suspicious lesions:
- No history of CIS or HNSCC
- History of clinically suspicious oral/oral pharyngeal lesions.
- Over 21 years old
- Not actively under treatment for any other type of malignancy, except Non-Melanoma Skin Cancer (NMSC)
- Must be willing to sign consent, have AFL screening with biopsies and sample collection, must be willing to complete a social and health history questionnaire
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- Patients with biopsy proven dysplasia, CIS or HNSCC prior to treatment:
- Patients with biopsy proven dysplasia, CIS or HNSCC without a prior history of an antineoplastic treatment, including chemo/radiation and Photodynamic Therapy
- Biopsy performed at an outside institution and referred for evaluation for treatment, or biopsied here at RPCI and proceeding for further care.
- Over 21 years of age.
- Must be willing to sign consent, have AFL screening with biopsies and sample collection, must be willing to complete a social and health history questionnaire
- Patients with clinically treated CIS or HNSCC amd no evidence of disease (NED):
- Patients with prior history of HNSCC, previously treated with either surgery alone or combination of therapy, including Head and Neck radiation, with or without chemotherapy and Photodynamic Therapy including at least 3 months following completion of definitive treatment.
- Over 21 years of age
- Must be willing to sign consent, have AFL screening with biopsies and sample collection, must be willing to complete a social and health history questionnaire
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
This research may help dentists or surgeons to better detect areas in the mouth that are either prone to cancer or are early cancers. The earlier the detection on cancer in the mouth, the better the chance that treatment or prevention can be more effective.
- Conditions
- Oral Cancer
- Medical subject headings
- Mouth Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
to investigate whether the use of a fluorescent light in the mouth can detect precancers or early cancers that are not seen on normal clinical examination.
The first purpose of this activity is to investigate whether the use of a fluorescent light in the mouth can detect precancers or early cancers that are not seen on normal clinical examination.
Measured: Once at time of consent (day 1)
Secondary outcomes (1)
The second purpose is to collect other samples from the mouth in hopes to identify changes in the proteins and/or genes that will help identify how cancers start in the mouth.
The second purpose is to collect other samples from the mouth in hopes to identify changes in the proteins and/or genes that will help identify how cancers start in the mouth.
Measured: Once at time of consent (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startMar 2006
- Primary completionOct 2013
- Study completionJan 2014
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 Roswell Park Cancer InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Schlecht, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531881
- Sponsor's protocol ID
- I 66805
- Status last verified
- Apr 2023
- First submitted
- 11 Jan 2012
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression
- ClinicalTrials.gov ID
- NCT01531881
- Acronym / sponsor ID
- I 66805
- Conditions
- Oral Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2006 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Feb 2012 (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 research may help dentists or surgeons to better detect areas in the mouth that are either prone to cancer or are early cancers. The earlier the detection on cancer in the mouth, the better the chance that treatment or prevention can be more effective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dental clinic patients
Key inclusion criteria (15 listed)
- No history of CIS or HNSCC
- History of clinically suspicious oral/oral pharyngeal lesions.
- Over 21 years old
- Not actively under treatment for any other type of malignancy, except Non-Melanoma Skin Cancer (NMSC)
- Must be willing to sign consent, have AFL screening with biopsies and sample collection, must be willing to complete a social and health history questionnaire
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to investigate whether the use of a fluorescent light in the mouth can detect precancers or early cancers that are not seen on normal clinical examination.
Time frame: Once at time of consent (day 1)
The first purpose of this activity is to investigate whether the use of a fluorescent light in the mouth can detect precancers or early cancers that are not seen on normal clinical examination.
1 secondary outcome
The second purpose is to collect other samples from the mouth in hopes to identify changes in the proteins and/or genes that will help identify how cancers start in the mouth.
Time frame: Once at time of consent (day 1)
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 28 Apr 2023.
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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.
Nicolas Schlecht principal investigator
Roswell Park Cancer Institute
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 Oral Cancer, run by Roswell Park Cancer Institute 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 15 inclusion and 0 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 28 Apr 2023. 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?
to investigate whether the use of a fluorescent light in the mouth can detect precancers or early cancers that are not seen on normal clinical examination. (time frame: Once at time of consent (day 1)). 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 28 Apr 2023.