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Prospective Registration of Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT02546895
Recruitment Status : Recruiting
First Posted : September 11, 2015
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Han-Sin Jeong, 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.

Condition or disease Intervention/treatment
Head and Neck Cancer Other: chart review

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
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Registration of Head and Neck Cancer Patients for Clinical Data and Tissue Collection
Study Start Date : September 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.

    Other Name: surveys


Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 years ]
    Revised RECIST guideline


Secondary Outcome Measures :
  1. Quality of life [ 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

  2. Identification of biomarkers of clinical significance (prognostic) [ Time Frame: 5 years ]
    Biomarkers associated with treatment outcomes (HPV, Epidermal growth factor receptor, p53, p16, etc)

  3. Number of participants with treatment-related morbidity [ Time Frame: 5 years ]
    CTCAE protocol

  4. Number of participants with treatment response [ Time Frame: 5 years ]
    Number of participants with treatment response

  5. Overall survival [ Time Frame: 5 years ]
    Revised RECIST guideline

  6. 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

  7. 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


Biospecimen Retention:   Samples With DNA
  1. Serum
  2. Tissue specimen


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pathologically proven head and neck cancer patients, who are referred to Samsung Medical Center
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546895


Contacts
Contact: Han-Sin Jeong, M.D. Ph.D. 82-2-3410-0291 hansin.jeong@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Eun-Hye Kim, RN    82-2-3410-2034    eh0502.kim@samsung.com   
Sponsors and Collaborators
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:
Hah, J. H. (2012). Personalized Treatment of Head and Neck Cancers and the Role of Head and Neck Surgeons. Korean Journal of Otorhinolaryngology-Head and Neck Surgery, 55(8), 471-475

Responsible Party: Han-Sin Jeong, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02546895     History of Changes
Other Study ID Numbers: 2015-06-132
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Han-Sin Jeong, Samsung Medical Center:
head and neck cancer patients
clinical data
tissue collection
prospective registration
patients

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