Study to Evaluate the Natural History of Head and Neck Cancer Precursors in Taiwan
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Study type: Observational

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. 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.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
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.
      
Keywords: Head and Neck Cancers; Larynx; Oropharynx; Oral Cavity