Head and Neck NeoplasmsNCT02017288
Study to Evaluate the Natural History of Head and Neck Cancer Precursors in Taiwan
An observational study of Head and Neck Neoplasms, run by National Cancer Institute (NCI) at 4 sites in Taiwan.
Trial summary
Background: Cancer of the mouth and throat is one of the most common cancers in Taiwan. This cancer develops over several years, beginning as white or red patches in the mouth or throat that become growths. It can also cause a condition that leads to rigidity of the cheeks. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Neoplasms
- Type of treatment
- Pill or oral medicine
- How many people
- 3,576 participants
- Where
- 4 sitesTaiwan
- Study dates
- 18 Nov 2013to 4 Feb 2021
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A prospective cohort study of 3000 patients with precursors to investigate the natural history of histologically-defined oral cancer precursor lesions and evaluate epidemiologic/ molecular predictors for progression. This prospective component will be complemented by cross-sectional comparisons of epidemiologic/molecular factors across 750 controls, 3000 precursors, and 750 cancers.
Who may be able to join
- We plan to recruit all patients (controls, precursors, and invasive cancers) at the aforementioned two hospitals. Doctors at these hospitals conduct routine visual and tactile examination as part of Taiwan s national oral cancer screening program. For this screening program, all individuals aged 21 years or older who chew betel-quid or smoke are screened through visual inspection for the presence of precursor lesions or cancer.
Who cannot join
- Participants younger than 21 years and individuals with a history of head and neck cancer will be excluded from the study.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City
China Medical University Hospital
Taichung, 40402
National Taiwan University Hospital
Taipei
Chang Gung Memorial Hospital- Taoyuan
Taoyuan
About this study
Official title: Natural History Of Oral Cancer Precursor Lesions: A Prospective Cohort Study
Background:
- Cancer of the mouth and throat is one of the most common cancers in Taiwan. This cancer develops over several years, beginning as white or red patches in the mouth or throat that become growths. It can also cause a condition that leads to rigidity of the cheeks. The growths can be identified when a doctor looks into a person s mouth. It is currently not clear why some people with abnormal growths progress to cancer while others do not. Researchers want to better understand why some patients with early abnormal growths get late abnormal growths. They also want to understand why some people get abnormal growths again, even after they receive treatment.
Read more
Objectives:
- To understand why some people with precancerous lesions in their mouth develop cancer while others do not.
Eligibility:
- Adults 21 years and older, some with abnormal growths in the mouth, some without any, and some with head and neck cancer.
Design:
- Participants will visit a hospital in Taiwan 2 times.
- At the first visit, participants will answer questions about their health, lifestyle, and family medical history. A doctor will examine the participant s mouth and take a small piece of any growth they see. They will do this with a brush. They will also photograph the participant s mouth. Participants will also give blood and saliva samples, plus a small sample of a mouth rinse.
- Participants who are diagnosed with a late abnormal growth that is not cancer will return for a second visit. They will answer the same questions and undergo the same procedures as at the first study.
Read the detailed description
Oral cancers are ideal candidates for screening, early detection, and secondary prevention given the amenability for visual inspection and specimen collection and the availability of recognized precursors. Yet, there are currently no guidelines for screening, treatment, or follow-up of patients with oral cancer precursors, in part, owing to the current gaps in knowledge regarding the natural history of precursor lesions. We propose to conduct a prospective cohort study of patients with oral cancer precursors to address these knowledge gaps and to investigate novel etiologic factors.
In preparation for the cohort study, we recently conducted a pilot study in Taiwan, a country with high oral cancer incidence. This pilot was aimed to streamline field operations and collect preliminary data to aid in the design of the cohort study. As detailed in our concept, we successfully accomplished all of the goals of our pilot study, including successful recruitment and retention of patients as well as the collection of critical preliminary data.
Based on these efforts, we are seeking approval to conduct a prospective cohort study of 3000 patients with precursors to investigate the natural history of histologically-defined oral cancer precursor lesions and evaluate epidemiologic/ molecular predictors for progression. After completion of the recruitment period, we plan to recruit an additional 500 patients with clinically-defined precancerous lesions for passive follow-up. The prospective component will be complemented by cross-sectional comparisons of epidemiologic/molecular factors across 750 controls, 3500 precursors, and 750 cancers.
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and Neck Cancers, Larynx, Oropharynx, Oral Cavity
- Medical subject headings
- Head and Neck Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer | Participants diagnosed with incident oral cancer | |
| Control | Participants without oral lesions or cancers matched to oral cancer/precursor participants on age, gender, smoking/betel nut habits | |
| Precursor | Participants clinically diagnosed with oral lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to dysplasia/cancer in participants with oral precursors.
Histologically confirmed progression to dysplasia/cancer in participants with oral precursors.
Measured: Follow-up visits every 6 months for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study start18 Nov 2013
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Cross-sectional
- Enrolment
- 3,576 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Taiwan University, Academia Sinica, Taiwan, China Medical University, China
- Responsible party
- Sponsor
- Investigators
- Anil K Chaturvedi, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017288
- Sponsor's protocol ID
- 999914018
- Other IDs
- 14-C-N018
- Status last verified
- Feb 2021
- First submitted
- 19 Dec 2013
- Last updated
- 8 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History Of Oral Cancer Precursor Lesions: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02017288
- Acronym / sponsor ID
- 999914018
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and Neck Cancers, Larynx, Oropharynx, Oral Cavity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,576 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- National Taiwan University, Academia Sinica, Taiwan, China Medical University, China
- Study start
- 18 Nov 2013 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 20 Dec 2013 (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.
Background:
- Cancer of the mouth and throat is one of the most common cancers in Taiwan. This cancer develops over several years, beginning as white or red patches in the mouth or throat that become growths. It can also cause a condition that leads to rigidity of the cheeks. The growths can be identified when a doctor looks into a person s mouth. It is currently not clear why some people with abnormal growths progress to cancer while others do not. Researchers want to better understand why some patients with early abnormal growths get late abnormal growths. They also want to understand why some people get abnormal growths again, even after they receive treatment.
Objectives:
- To understand why some people with precancerous lesions in their mouth develop cancer while others do not.
Eligibility:
- Adults 21 years and older, some with abnormal growths in the mouth, some without any, and some with head and neck cancer.
Design:
- Participants will visit a hospital in Taiwan 2 times.
- At the first visit, participants will answer questions about their health, lifestyle, and family medical history. A doctor will examine the participant s mouth and take a small piece of any growth they see. They will do this with a brush. They will also photograph the participant s mouth. Participants will also give blood and saliva samples, plus a small sample of a mouth rinse.
- Participants who are diagnosed with a late abnormal growth that is not cancer will return for a second visit. They will answer the same questions and undergo the same procedures as at the first study.
Detailed description
Oral cancers are ideal candidates for screening, early detection, and secondary prevention given the amenability for visual inspection and specimen collection and the availability of recognized precursors. Yet, there are currently no guidelines for screening, treatment, or follow-up of patients with oral cancer precursors, in part, owing to the current gaps in knowledge regarding the natural history of precursor lesions. We propose to conduct a prospective cohort study of patients with oral cancer precursors to address these knowledge gaps and to investigate novel etiologic factors.
In preparation for the cohort study, we recently conducted a pilot study in Taiwan, a country with high oral cancer incidence. This pilot was aimed to streamline field operations and collect preliminary data to aid in the design of the cohort study. As detailed in our concept, we successfully accomplished all of the goals of our pilot study, including successful recruitment and retention of patients as well as the collection of critical preliminary data.
Based on these efforts, we are seeking approval to conduct a prospective cohort study of 3000 patients with precursors to investigate the natural history of histologically-defined oral cancer precursor lesions and evaluate epidemiologic/ molecular predictors for progression. After completion of the recruitment period, we plan to recruit an additional 500 patients with clinically-defined precancerous lesions for passive follow-up. The prospective component will be complemented by cross-sectional comparisons of epidemiologic/molecular factors across 750 controls, 3500 precursors, and 750 cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer | – | –Participants diagnosed with incident oral cancer |
| Control | – | –Participants without oral lesions or cancers matched to oral cancer/precursor participants on age, gender, smoking/betel nut habits |
| Precursor | – | –Participants clinically diagnosed with oral lesions |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective cohort study of 3000 patients with precursors to investigate the natural history of histologically-defined oral cancer precursor lesions and evaluate epidemiologic/ molecular predictors for progression. This prospective component will be complemented by cross-sectional comparisons of epidemiologic/molecular factors across 750 controls, 3000 precursors, and 750 cancers.
Key inclusion criteria (1 listed)
- We plan to recruit all patients (controls, precursors, and invasive cancers) at the aforementioned two hospitals. Doctors at these hospitals conduct routine visual and tactile examination as part of Taiwan s national oral cancer screening program. For this screening program, all individuals aged 21 years or older who chew betel-quid or smoke are screened through visual inspection for the presence of precursor lesions or cancer.
Key exclusion criteria (1 listed)
- Participants younger than 21 years and individuals with a history of head and neck cancer will be excluded from the study.
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
Progression to dysplasia/cancer in participants with oral precursors.
Time frame: Follow-up visits every 6 months for 5 years
Histologically confirmed progression to dysplasia/cancer in participants with oral precursors.
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 8 Feb 2021.
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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.
Anil K Chaturvedi, M.D. principal investigator
National Cancer Institute (NCI)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms, run by National Cancer Institute (NCI) at 4 sites in Taiwan.
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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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?
Progression to dysplasia/cancer in participants with oral precursors. (time frame: Follow-up visits every 6 months for 5 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 8 Feb 2021.