Prospective Registration of Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
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 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). To establish the predictive model for treatment outcomes and treatment-related morbidities. To develop the biomarkers as predictive and/or prognostic factors.

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

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

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Other: chart review


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: chart review|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of biomarkers of clinical significance (prognostic) | Biomarkers associated with treatment outcomes (HPV, Epidermal growth factor receptor, p53, p16, etc) | 5 years | 
| Number of participants with treatment-related morbidity | CTCAE protocol | 5 years | 
| Number of participants with treatment response | Number of participants with treatment response | 5 years | 
| Overall survival | Revised RECIST guideline | 5 years | 
| Scores of distress questionnaire | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
head and neck cancer patients, clinical data, tissue collection, prospective registration, patients