An observational study in Head and Neck Neoplasms, sponsored by National Cancer Institute (NCI). Completed at 4 sites in Taiwan. Open to participants aged 21 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by National Cancer Institute (NCI) · Observational
Background:
Objectives:
Eligibility:
Design:
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.
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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.
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.
EXCLUSION CRITERIA
Participants younger than 21 years and individuals with a history of head and neck cancer will be excluded from the study.
Participants diagnosed with incident oral cancer
Participants without oral lesions or cancers matched to oral cancer/precursor participants on age, gender, smoking/betel nut habits
Participants clinically diagnosed with oral lesions
Progression to dysplasia/cancer in participants with oral precursors.
Histologically confirmed progression to dysplasia/cancer in participants with oral precursors.
Time frame: Follow-up visits every 6 months for 5 years
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)