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NCT Number: NCT02546895

Prospective Registration of Head and Neck Cancer

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chart review

Other

The patient charts will be reviewed to determine pretreatment characteristics, treatment-related adverse events, time to progression and overall survival.

Behavioral: Questionnaires Completion of 3 questionnaires 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. It may take about 30 minutes to complete the questionnaires each time.

Other names: surveys

Primary outcomes

  1. Progression-free survival

    Time frame: 3 years

    Revised RECIST guideline

Secondary outcomes

  1. Identification of biomarkers of clinical significance (prognostic)

    Time frame: 5 years

    Biomarkers associated with treatment outcomes (HPV, Epidermal growth factor receptor, p53, p16, etc)

  2. Number of participants with treatment-related morbidity

    Time frame: 5 years

    CTCAE protocol

  3. Number of participants with treatment response

    Time frame: 5 years

    Number of participants with treatment response

  4. Overall survival

    Time frame: 5 years

    Revised RECIST guideline

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Sep 11, 2015
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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