Prospective Registration of Head and Neck Cancer

April 21, 2026 updated by: Han-Sin Jeong, Samsung Medical Center

Prospective Registration of Head and Neck Cancer Patients for Clinical Data and Tissue Collection

Head and neck cancers account for the sixth leading cause of cancers worldwide. The annual incidence of Head and neck cancers is more than 650,000 the patients each year. Head and neck cancers are associated with smoking, alcohol consumption, human papilloma virus (type 16 and 18) and previous exposure to radiation.

So far, most of clinical and research data about head and neck cancers, such as the etiology, pathogenesis, prognosis factors and associated factors, treatment outcomes, are from Western countries. However, due to various environmental factors, for example race, genetics, geographical factors, general hygiene and health care system differences, the possibility of differences of disease characteristics between Western and Asian people should be considered.

For several decades, there have been many studies about treatment modalities (surgery, chemotherapy, and radiation therapy), complications and side effects for head and neck cancers in the West. Many institutions tried to improve the survival rate and resolve the toxicity of chemotherapy and radiation treatment for head and neck cancer patients. However there has been little information about the characteristics of head and neck cancers, effectiveness of treatment (survival rate, recurrence, and complication rate), and prognosis, particularly in Korean as well as in Asian patients.

Therefore it is necessary to evaluate and analyze the features of head and neck cancers such as etiology, pathogenesis, risk factors, prognostic factors, treatment outcomes in a site specific cohort (South Korea) separately. It could be helpful to improve the treatment outcomes of head and neck cancers overall, to design race or site specific treatments for head and neck cancers, and to develop management strategy common in Asia as well as the West.

The purpose of this study is

  1. To establish the prospective tumor registry about patient's information, treatment-related morbidities, treatment outcomes and quality of life, in addition to the prospective collection of patient samples (blood and tumor tissues).
  2. To establish the predictive model for treatment outcomes and treatment-related morbidities.
  3. To develop the biomarkers as predictive and/or prognostic factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Review of medical records Medical records of enrolled patients will be reviewed to evaluate clinical characteristics, treatment-related adverse events, time to progression and overall survival.

Behavioral : Questionnaires 3 times : Prior to the 1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment Other Names : Surveys

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 135-710
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Pathologically proven head and neck cancer patients, who are referred to Samsung Medical Center

Description

Inclusion Criteria:

  • Adults over 19 years-old

  • Patients diagnosed as head and neck cancer histopathologically according to American Joint Committee on Cancer, Cancer staging manual, 7th edition at Samsung Medical Center:

    • Comprise a part of head and neck
    • Oral cavity
    • Pharynx
    • Larynx
    • Hypopharynx
    • Nasal cavity
    • Paranasal sinus
    • Nasopharynx
    • Salivary gland
    • Skin in the head and neck
  • In case patients are diagnosed at other hospitals, it can be possible to register the tissue of cancer cell with Samsung medical center and confirm the diagnosis by pathologists of Samsung medical center.

  • Histopathological type:

    • Squamous cell carcinoma
    • Malignant melanoma
    • Sarcoma and other carcinomas are included.
  • Metastasis of Unknown Origin (MUO) at head and neck is included.
  • Patients who receive a proper treatment as scheduled.
  • Informed consents: patients who understand the purpose of study and are capable of giving a written consent.

Exclusion criteria:

  • Patients who do not meet the requirements of inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 3 years
Revised RECIST guideline
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of biomarkers of clinical significance (prognostic)
Time Frame: 5 years
Biomarkers associated with treatment outcomes (HPV, Epidermal growth factor receptor, p53, p16, etc)
5 years
Number of participants with treatment-related morbidity
Time Frame: 5 years
CTCAE protocol
5 years
Number of participants with treatment response
Time Frame: 5 years
Number of participants with treatment response
5 years
Overall survival
Time Frame: 5 years
Revised RECIST guideline
5 years
Scores of distress questionnaire
Time Frame: 1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment
QLQ HN43
1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment
Scores of support survey
Time Frame: 1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment
QLQ HN43
1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment
Quality of life score
Time Frame: 1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment
QLQ HN43
1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Han-Sin Jeong, M.D.Ph.D., Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
  • Principal Investigator: Se-Hoon Lee, M.D.Ph.D., Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
  • Principal Investigator: Dongryul Oh, M.D.Ph.D., Department of Radiation Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
  • Study Chair: Chung-Hwan Baek, M.D.Ph.D., Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
  • Study Chair: Young-Ik Son, M.D.Ph.D., Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
  • Study Chair: Man Ki Chung, M.D.Ph.D., Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
  • Study Chair: Young Chan Ahn, M.D.Ph.D., Department of Radiation Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
  • Study Chair: Myung-Ju Ahn, M.D.Ph.D., Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
  • Study Chair: Keunchil Park, M.D.Ph.D., Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimated)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-06-132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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