Head And Neck CancerPhase 3NCT00537199
OraTest in Combination With Visual Examination and Visual Examination Alone
A Phase 3 study testing Visual Examination and OraTest in people with Head And Neck Cancer and Oropharynx Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To assess the ratio in sensitivities of OraTest® in combination with visual examination versus visual examination alone in the detection of serious pathology defined as severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head And Neck Cancer, Oropharynx Cancer
- What is being tested?
- Visual Examination and OraTest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- High risk of oral cancer as defined by a twenty-pack/year cigarette smoking history or equivalent and is either a current smoker or has quit smoking within the last 24 months. Twenty-pack/year equivalent is defined as ½ pack/day for 40 years, or one pack/day for 20 years, or 2 packs/day for 10 years, or 4 packs/day for 5 years. AND/OR;
- Ten-year history of twenty orally-consumed alcohol units/week and is either a current drinker or has quit drinking within the last 24 months. Twenty orally-consumed alcohol units/week is defined as the equivalent of twenty - 1 ounce shots of whisky or spirits/week (20 ounces = 600 mL), or twenty - 3 ounce glasses of wine/week (60 ounces = 1800 mL), or twenty - 12 ounce glasses of beer/week (240 ounces = 7200 mL);
- Male or female, at least 45 years of age;
- Written informed consent.
- Females of childbearing potential may be enrolled following a negative urine pregnancy test performed at the SE visit. Abstinence will be considered an acceptable form of birth control.
Who cannot join
- History of oral cancer, surgery or biopsy for suspected oral neoplasm;
- History of recent oral surgery, periodontal treatment, or oral trauma (<14 days) or current orthodonture (e.g., braces);
- Known hypersensitivity to study drug or its analogs;
- Active and uncontrolled infection or any other severe concurrent disease that in the judgment of the investigator would make the patient inappropriate for entry into this study;
- Psychiatric disorders which would interfere with informed consent or follow-up;
- Use of any investigational agent within previous 30 days;
Show all 9Show fewer
- Female that is lactating or demonstrating positive pregnancy test;
- Patients in whom betel nut use/abuse has been reported within the past 5 years;
- Patients currently taking medication containing prohibited dyes.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Evaluation of OraTest in Combination With Visual Examination in the Improved Detection of Oral Mucosal Lesions Suspicious of Serious Pathology in High-Risk Patients for the Purpose of Referral to the Health Care Professional Experienced in Oral Cancer: Phase III Clinical Trial Comparing the Sensitivity and Assessing the Specificity of OraTest in Combination With Visual Examination and Visual Examination Alone in Patients at High Risk as Defined by Age and Lifestyle Factors (ZIL-401)
Primary Objectives:
- To assess the ratio in sensitivities of OraTest® in combination with visual examination versus visual examination alone in the detection of serious pathology defined as severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors.
- To estimate the adjusted specificity of OraTest® in combination with visual examination in the detection of severe dysplasia, CIS, or cancer of the O/OP cavity.
Read more
Secondary Objectives:
- To assess the ratio of sensitivity of OraTest® in combination with visual examination versus visual examination alone in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors.
- To obtain the adjusted specificity of OraTest® in combination with visual examination in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS or cancer of the O/OP cavity.
- To evaluate the chromosomal status of the positively staining lesions with respect to 3p, 9p, or 17p deletions.
- To carry out gene expression studies on biopsies and map these onto an analysis of the widespread chromosomal imbalances in stain-positive and stain-negative lesions.
- To evaluate the quantitative and qualitative toxicities, as well as other safety parameters, of tolonium chloride 5 mg/mL (OraTest®).
Read the detailed description
OraTest® is a blue dye that is designed to stain cancer cells differently than normal cells.
SCHEDULED EVALUATION (FIRST VISIT):
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your medical history will be recorded. Women who are able to have children must have a negative urine pregnancy test. Your heart rate, breathing, temperature, and blood pressure will be measured before as well as after the first visit.
Visual Exam - If you are found to be eligible to take part in this study, you will have a visual examination where a doctor (Examiner #1) will look inside your mouth very carefully to look for any abnormal lesions and check the glands in your neck. This is called the visual exam.
Rinse Staining Procedure (OraTest®) - A second doctor (Examiner #2) will perform another oral exam, followed by the new test using OraTest®. This new test uses a blue dye which may stain any potential cancer blue so it may make it easier for the doctor to detect any abnormal lesions in your mouth. You will be asked not to have intensely-colored sweets like lollipops or drinks like black currant juice within 24 hours of your scheduled visit. First you will rinse your mouth with about 6 teaspoons of vinegar solution for about 20 seconds and spit it out. Next you will rinse your mouth with 6 teaspoons of water for 20 seconds and spit it out. Then you will rinse your mouth with about 2 teaspoons of OraTest® for 20 seconds and spit it out. Then you will rinse your mouth with about 6 teaspoons of vinegar solution for 20 seconds and then spit it out. Then you will rinse your mouth with 6 teaspoons of water for 20 seconds and spit it out. Examiner 2 will then check and see if any abnormal tissue absorbed the dye.
If no suspicious lesions are found by either doctor, you will have completed the study. You will be asked to notify the clinic, by phone, if any side effects occur within 7 days after your visit. If you are unable to phone the clinic, you will be given diary cards to record these side effects. The diary cards are to be mailed to the doctor in the pre-stamped envelope given to you.
If any suspicious lesions are found by either doctor (or both), then you will be asked to return in about 2 weeks to confirm the result. This is called the Confirmation Exam.
CONFIRMATION EXAM (SECOND VISIT):
At the visit to confirm the result, you will be examined by the same doctor(s) who found the suspicious lesion(s). The doctor(s) will use the same examination method that was used during the first visit. Your heart rate, breathing, temperature, and blood pressure will be measured before as well as after the second visit.
If you have any suspicious lesions, a specialist at M. D. Anderson will biopsy your lesion(s), at this second visit or within 5 days after the visit. During the biopsy, the doctor may use the OraTest® cotton swab to help locate the suspicious spot. If the dye is used at the biopsy visit, your heart rate, breathing, temperature, and blood pressure will be measured before and after the use of OraTest®. After locating the spot, the doctor will perform the biopsy. This means that some tissue lining in your mouth from the suspicious area will be removed. Some of your tissue will be sent to a laboratory for diagnosis. Your doctor will decide the type of care you may need based on the results of the biopsy. The biopsy procedure is standard practice and may happen even if you did not participate in this study. After the biopsy is taken of the lesion, you will have completed the study.
If a suspicious lesion is found and you are required to have a biopsy, a sample of tissue from the biopsy will be sent to a laboratory outside of M.D. Anderson for review and diagnosis. Medical research including genetic testing, chromosomal analysis and other tests may be performed on your biopsy. These samples cannot be returned to you because the tissue is destroyed during the genetic tests. Before your tissue is sent to the outside laboratory your name and any personal identifying information will be coded to protect your privacy. M. D. Anderson will not have oversight of any leftover tissue and/or blood that will be banked by BRT Laboratories Inc. for additional research.
If no suspicious lesions are seen at this second visit, then you have completed the study. If the dye was used during the exam, then you will be asked to notify the clinic by phone if any side effects occur within 7 days after your visit. If you are unable to phone the clinic, you will be given diary cards to record these side effects. The diary cards are to be mailed to the doctor in the pre-stamped envelope given to you.
This is an investigational study. OraTest® has not yet been FDA approved for commercial use. All study procedures and OraTest® will be provided free of charge; the Sponsor will pay for the study drug and pregnancy test if necessary. If further standard of care is needed (for example, due to abnormalities found), you and/or your insurance company will be responsible for the cost. Insurance companies and Medicare may not pay for the costs of some research studies like this one. If your insurance company does not cover the cost of care, then you will have to pay these costs. You have the right to ask what it will cost you to take part in this study or to have other treatments. If you withdraw from the study early, you will only be paid for the portion of the study that you completed. Up to 4000 patients will take part in this multicenter study. Up to 50 will be enrolled at M. D. Anderson.
- Conditions
- Head And Neck Cancer, Oropharynx Cancer
- Being tested
- Visual Examination, OraTest
- Keywords
- Head And Neck, Oropharynx, Oral Cancer, OraTest, OraTest Dye, Rinse Staining Procedure, Visual Examination
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual ExaminationOther
Two (2) scheduled visits for visual examination of mouth for abnormal lesions and glands in the neck.
OraTestDrug
Also called OraTest Dye, Rinse Staining Procedure
Two (2) scheduled visits for rinse staining: 2 teaspoons of OraTest for 20 seconds, then spit.
| Study group | Role | What they receive |
|---|---|---|
| OraTest + Visual Exam | Other | OraTest dye Receives: Other: Visual Examination; Drug: OraTest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone
Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone.
Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye.
Measured: Following two (2) scheduled visits for visual examination, up to one month following first exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startNov 2006
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Study terminated early as per request by sponsor, Zila Biotechnology, Inc.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head And Neck 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zila Biotechnology, Inc.
- Responsible party
- Sponsor
- Investigators
- Mark Chambers, DMD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537199
- Sponsor's protocol ID
- 2005-1008
- Status last verified
- Dec 2009
- First submitted
- 26 Sep 2007
- Last updated
- 13 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of OraTest in Combination With Visual Examination in the Improved Detection of Oral Mucosal Lesions Suspicious of Serious Pathology in High-Risk Patients for the Purpose of Referral to the Health Care Professional Experienced in Oral Cancer: Phase III Clinical Trial Comparing the Sensitivity and Assessing the Specificity of OraTest in Combination With Visual Examination and Visual Examination Alone in Patients at High Risk as Defined by Age and Lifestyle Factors (ZIL-401)
- ClinicalTrials.gov ID
- NCT00537199
- Acronym / sponsor ID
- 2005-1008
- Conditions
- Head And Neck Cancer, Oropharynx Cancer
- Keywords
- Head And Neck, Oropharynx, Oral Cancer, OraTest, OraTest Dye, Rinse Staining Procedure, Visual Examination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early as per request by sponsor, Zila Biotechnology, Inc.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Zila Biotechnology, Inc.
- Study start
- Nov 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Posted 18 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To assess the ratio in sensitivities of OraTest® in combination with visual examination versus visual examination alone in the detection of serious pathology defined as severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors.
- To estimate the adjusted specificity of OraTest® in combination with visual examination in the detection of severe dysplasia, CIS, or cancer of the O/OP cavity.
Secondary Objectives:
- To assess the ratio of sensitivity of OraTest® in combination with visual examination versus visual examination alone in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors.
- To obtain the adjusted specificity of OraTest® in combination with visual examination in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS or cancer of the O/OP cavity.
- To evaluate the chromosomal status of the positively staining lesions with respect to 3p, 9p, or 17p deletions.
- To carry out gene expression studies on biopsies and map these onto an analysis of the widespread chromosomal imbalances in stain-positive and stain-negative lesions.
- To evaluate the quantitative and qualitative toxicities, as well as other safety parameters, of tolonium chloride 5 mg/mL (OraTest®).
Detailed description
OraTest® is a blue dye that is designed to stain cancer cells differently than normal cells.
SCHEDULED EVALUATION (FIRST VISIT):
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your medical history will be recorded. Women who are able to have children must have a negative urine pregnancy test. Your heart rate, breathing, temperature, and blood pressure will be measured before as well as after the first visit.
Visual Exam - If you are found to be eligible to take part in this study, you will have a visual examination where a doctor (Examiner #1) will look inside your mouth very carefully to look for any abnormal lesions and check the glands in your neck. This is called the visual exam.
Rinse Staining Procedure (OraTest®) - A second doctor (Examiner #2) will perform another oral exam, followed by the new test using OraTest®. This new test uses a blue dye which may stain any potential cancer blue so it may make it easier for the doctor to detect any abnormal lesions in your mouth. You will be asked not to have intensely-colored sweets like lollipops or drinks like black currant juice within 24 hours of your scheduled visit. First you will rinse your mouth with about 6 teaspoons of vinegar solution for about 20 seconds and spit it out. Next you will rinse your mouth with 6 teaspoons of water for 20 seconds and spit it out. Then you will rinse your mouth with about 2 teaspoons of OraTest® for 20 seconds and spit it out. Then you will rinse your mouth with about 6 teaspoons of vinegar solution for 20 seconds and then spit it out. Then you will rinse your mouth with 6 teaspoons of water for 20 seconds and spit it out. Examiner 2 will then check and see if any abnormal tissue absorbed the dye.
If no suspicious lesions are found by either doctor, you will have completed the study. You will be asked to notify the clinic, by phone, if any side effects occur within 7 days after your visit. If you are unable to phone the clinic, you will be given diary cards to record these side effects. The diary cards are to be mailed to the doctor in the pre-stamped envelope given to you.
If any suspicious lesions are found by either doctor (or both), then you will be asked to return in about 2 weeks to confirm the result. This is called the Confirmation Exam.
CONFIRMATION EXAM (SECOND VISIT):
At the visit to confirm the result, you will be examined by the same doctor(s) who found the suspicious lesion(s). The doctor(s) will use the same examination method that was used during the first visit. Your heart rate, breathing, temperature, and blood pressure will be measured before as well as after the second visit.
If you have any suspicious lesions, a specialist at M. D. Anderson will biopsy your lesion(s), at this second visit or within 5 days after the visit. During the biopsy, the doctor may use the OraTest® cotton swab to help locate the suspicious spot. If the dye is used at the biopsy visit, your heart rate, breathing, temperature, and blood pressure will be measured before and after the use of OraTest®. After locating the spot, the doctor will perform the biopsy. This means that some tissue lining in your mouth from the suspicious area will be removed. Some of your tissue will be sent to a laboratory for diagnosis. Your doctor will decide the type of care you may need based on the results of the biopsy. The biopsy procedure is standard practice and may happen even if you did not participate in this study. After the biopsy is taken of the lesion, you will have completed the study.
If a suspicious lesion is found and you are required to have a biopsy, a sample of tissue from the biopsy will be sent to a laboratory outside of M.D. Anderson for review and diagnosis. Medical research including genetic testing, chromosomal analysis and other tests may be performed on your biopsy. These samples cannot be returned to you because the tissue is destroyed during the genetic tests. Before your tissue is sent to the outside laboratory your name and any personal identifying information will be coded to protect your privacy. M. D. Anderson will not have oversight of any leftover tissue and/or blood that will be banked by BRT Laboratories Inc. for additional research.
If no suspicious lesions are seen at this second visit, then you have completed the study. If the dye was used during the exam, then you will be asked to notify the clinic by phone if any side effects occur within 7 days after your visit. If you are unable to phone the clinic, you will be given diary cards to record these side effects. The diary cards are to be mailed to the doctor in the pre-stamped envelope given to you.
This is an investigational study. OraTest® has not yet been FDA approved for commercial use. All study procedures and OraTest® will be provided free of charge; the Sponsor will pay for the study drug and pregnancy test if necessary. If further standard of care is needed (for example, due to abnormalities found), you and/or your insurance company will be responsible for the cost. Insurance companies and Medicare may not pay for the costs of some research studies like this one. If your insurance company does not cover the cost of care, then you will have to pay these costs. You have the right to ask what it will cost you to take part in this study or to have other treatments. If you withdraw from the study early, you will only be paid for the portion of the study that you completed. Up to 4000 patients will take part in this multicenter study. Up to 50 will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OraTest + Visual Exam | Other | Other: Visual Examination, Drug: OraTestOraTest dye |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- High risk of oral cancer as defined by a twenty-pack/year cigarette smoking history or equivalent and is either a current smoker or has quit smoking within the last 24 months. Twenty-pack/year equivalent is defined as ½ pack/day for 40 years, or one pack/day for 20 years, or 2 packs/day for 10 years, or 4 packs/day for 5 years. AND/OR;
- Ten-year history of twenty orally-consumed alcohol units/week and is either a current drinker or has quit drinking within the last 24 months. Twenty orally-consumed alcohol units/week is defined as the equivalent of twenty - 1 ounce shots of whisky or spirits/week (20 ounces = 600 mL), or twenty - 3 ounce glasses of wine/week (60 ounces = 1800 mL), or twenty - 12 ounce glasses of beer/week (240 ounces = 7200 mL);
- Male or female, at least 45 years of age;
- Written informed consent.
- Females of childbearing potential may be enrolled following a negative urine pregnancy test performed at the SE visit. Abstinence will be considered an acceptable form of birth control.
Key exclusion criteria (9 listed)
- History of oral cancer, surgery or biopsy for suspected oral neoplasm;
- History of recent oral surgery, periodontal treatment, or oral trauma (<14 days) or current orthodonture (e.g., braces);
- Known hypersensitivity to study drug or its analogs;
- Active and uncontrolled infection or any other severe concurrent disease that in the judgment of the investigator would make the patient inappropriate for entry into this study;
- Psychiatric disorders which would interfere with informed consent or follow-up;
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 |
|---|---|---|
| Visual ExaminationTwo (2) scheduled visits for visual examination of mouth for abnormal lesions and glands in the neck. | Other | OraTest + Visual Exam |
| OraTestAlso: OraTest Dye, Rinse Staining ProcedureTwo (2) scheduled visits for rinse staining: 2 teaspoons of OraTest for 20 seconds, then spit. | Drug | OraTest + Visual Exam |
Primary outcome
Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone
Time frame: Following two (2) scheduled visits for visual examination, up to one month following first exam
Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone. Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Head And Neck Cancer
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
Brain Metastases, Bone Metastases
Not yet recruitingPhase 3
Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma
Esophageal Cancer
RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Barrett Esophagus, Barrett Esophagus Adenocarcinoma
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
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 Chambers, DMD 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 Phase 3 study testing Visual Examination and OraTest in people with Head And Neck Cancer and Oropharynx 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 5 inclusion and 9 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 13 May 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone (time frame: Following two (2) scheduled visits for visual examination, up to one month following first exam). 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 13 May 2016.