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Study to Evaluate the Natural History of Head and Neck Cancer Precursors in Taiwan

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ClinicalTrials.gov Identifier: NCT02017288
Recruitment Status : Recruiting
First Posted : December 20, 2013
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
National Taiwan University
Academia Sinica, Taiwan
China Medical University, China
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

December 19, 2013
December 20, 2013
June 13, 2018
December 19, 2013
November 30, 2025   (Final data collection date for primary outcome measure)
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.
investigate the early natural history of HNSCC precursors [ Time Frame: 1 year ]
Complete list of historical versions of study NCT02017288 on ClinicalTrials.gov Archive Site
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Study to Evaluate the Natural History of Head and Neck Cancer Precursors in Taiwan
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.

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.

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. This prospective component will be complemented by cross-sectional comparisons of epidemiologic/molecular factors across 500 controls, 3000 precursors, and 500 cancers.

Observational
Observational Model: Cohort
Time Perspective: Other
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Non-Probability Sample
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.
Head and Neck Neoplasms
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
300
November 30, 2025
November 30, 2025   (Final data collection date for primary outcome measure)
  • INCLUSION CRITERIA

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

The following individuals will be excluded from the study: subjects younger than 21 years, individuals with a history of cancer, and mentally incompetent individuals.

Sexes Eligible for Study: All
21 Years to 100 Years   (Adult, Older Adult)
No
Contact: Anil K Chaturvedi, M.D. (240) 276-7193 chaturva@mail.nih.gov
China,   Taiwan
United States
 
NCT02017288
999914018
14-C-N018
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National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
  • National Taiwan University
  • Academia Sinica, Taiwan
  • China Medical University, China
Principal Investigator: Anil K Chaturvedi, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
April 26, 2018