Trial record 7 of 921 for:    Open Studies | "Head and Neck Neoplasms"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborators:
National Taiwan University
Academia Sinica
China Medical University, China
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT02017288
First received: December 19, 2013
Last updated: September 19, 2014
Last verified: March 2014
  Purpose

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.

Condition
Head and Neck Neoplasms

Study Type: Observational
Official Title: Pilot Study to Evaluate the Natural History of Head and Neck Cancer Precursors in Taiwan

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Cancer [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Pre-Cancer [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Study Start Date: November 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Head and neck squamous cell carcinomas (HNSCCs), which include cancers of the oral cavity, oropharynx, and larynx, are the sixth most common cancer worldwide with an estimated annual burden of 355,000 deaths and 633,000 incident cases. HNSCCs are ideal candidates for screening, early detection, and secondary prevention given the amenability for visual inspection and specimen collection, the availability of recognized premalignant lesions (clinically-defined as leukoplakia, erythroplakia, and submucous fibrosis and histologically-defined based on the grade of dysplasia), and evidence that screening and early detection can lead to significant reductions in mortality. Nonetheless, there are currently no guidelines for screening, treatment, or follow-up of patients with HNSCC precursors, in part, owing to the current gaps in knowledge regarding the early and long-term natural history of clinical/histologic precursor lesions, the lack of validated predictive biomarkers, and thus the inability to accurately identify those lesions that are most likely to progress to cancer.

To address these gaps in knowledge, we plan to conduct a prospective cohort study to investigate the early natural history of HNSCC precursors, including: 1) the rates and time course of progression or regression of precursor lesions, 2) ability of epidemiologic variables and tissue-based biomarkers in predicting progression/regression, and 3) feasibility of identifying promising biomarkers in less invasively collected specimens.

The current concept pertains to a pilot study in Taiwan to evaluate the feasibility of conducting a prospective cohort study. The goals of the pilot study are: 1) to pilot the study procedures, including recruitment and follow-up of participants, collection of questionnaire data, and collection, storage, and testing of biologic specimens and 2) to collect preliminary data, such as prevalence of risk factors and histologic precursors, to aid in the design of a cohort study. Furthermore, the pilot study will be adequately large to conduct case-control comparisons of risk factors and molecular markers across the control precursor cancer continuum.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017288

Contacts
Contact: Anil K Chaturvedi, M.D. (240) 276-7193 chaturva@mail.nih.gov

Locations
China
National Taiwan University Recruiting
Taiwan, China
Sponsors and Collaborators
National Taiwan University
Academia Sinica
China Medical University, China
Investigators
Principal Investigator: Anil K Chaturvedi, M.D. National Cancer Institute (NCI)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT02017288     History of Changes
Other Study ID Numbers: 999914018, 14-C-N018
Study First Received: December 19, 2013
Last Updated: September 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Head and Neck Cancers
Larynx
Oropharynx
Oral Cavity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014