Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-30 @ 3:03 AM
Study NCT ID:
NCT02546895
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2015-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Registration of Head and Neck Cancer
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
Prospective Registration of Head and Neck Cancer Patients for Clinical Data and Tissue Collection
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: