Clinical trial NCT02546895: Prospective Registration of Head and Neck Cancer
Official title: Prospective Registration of Head and Neck Cancer Patients for Clinical Data and Tissue Collection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Keywords: head and neck cancer patients
clinical data
tissue collection
prospective registration
patients
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pathologically proven head and neck cancer patients, who are referred to Samsung Medical Center

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

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.

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

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

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Identification of biomarkers of clinical significance (prognostic)
timeFrame: 5 years
measure: Number of participants with treatment-related morbidity
timeFrame: 5 years
measure: Number of participants with treatment response
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Scores of distress questionnaire
timeFrame: 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
measure: Scores of support survey
timeFrame: 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
measure: Quality of life score
timeFrame: 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 outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
name: Han-Sin Jeong, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
name: Se-Hoon Lee, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
name: Dongryul Oh, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
name: Chung-Hwan Baek, M.D.Ph.D.
role: STUDY_CHAIR
affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
name: Young-Ik Son, M.D.Ph.D.
role: STUDY_CHAIR
affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
name: Man Ki Chung, M.D.Ph.D.
role: STUDY_CHAIR
affiliation: Department of Radiation Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
name: Young Chan Ahn, M.D.Ph.D.
role: STUDY_CHAIR
affiliation: Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
name: Myung-Ju Ahn, M.D.Ph.D.
role: STUDY_CHAIR
affiliation: Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
name: Keunchil Park, M.D.Ph.D.
role: STUDY_CHAIR
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