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

NCT02017288 | Completed

• 2 other identifiers: 99991401814-C-N018
• Study Type: observational
• Target: 3,576
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Head and Neck Neoplasms

Keywords

Head and Neck Cancers; Larynx; Oropharynx; Oral Cavity

Outcome Measures

Primary Outcomes (1)

• Progression to dysplasia/cancer in participants with oral precursors.

  Histologically confirmed progression to dysplasia/cancer in participants with oral precursors.

  Follow-up visits every 6 months for 5 years

Study Arms (3)

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

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Participants younger than 21 years and individuals with a history of head and neck cancer will be excluded from the study.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• National Taiwan University: collaborator
• Academia Sinica, Taiwan: collaborator
• China Medical University, China: collaborator

Study Sites (4)

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, 40402, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital- Taoyuan

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Anil K Chaturvedi, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 20, 2013
• Study Start: November 18, 2013
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

TW (4)