T1622 The Registry Study of Genetic Alterations of Melanoma in Taiwan

Status: Recruiting
Location: See all (16) locations...
Study Type: Observational
SUMMARY

Cutaneous melanoma is the most aggressive malignancy in skin cancers. Cutaneous melanoma is a rare disease in Taiwan with an incidence rate of around 1/100,000. Acral lentiginous melanoma is the most common subtype and comprises more than half of cutaneous melanoma in Asia including Taiwan but only 1% in Caucasians. In addition, mucosal melanoma accounts for more than 20% of malignancy melanoma in Taiwan but only 1% in Caucasians. Acral and mucosal melanomas have distinct epidemiological, clinical, pathological and genetic features from non-acral melanoma which is commonly seen in Western countries. Comparing with melanoma in Caucasians, Asian melanoma has higher recurrence rate after primary surgery, lower response rate to immunotherapy, and shorter progression-free survival for immunotherapy and targeted therapy leading generally poor survival outcomes regardless stage.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age \> 18 years old

• Pathologically confirmed melanoma. (Patients with additional malignancies requiring treatment or follow-up are allowed. Only treatment for melanoma should be recorded).

• ECOG performance status \< 3

• Cohort 1(early acral melanoma): melanoma, stage I/II; Cohort 2 (locally advanced acral melanoma): melanoma, stage III, resectable; and Cohort 3 (advanced): unresectable / metastatic melanoma, stage III/IV or recurrent melanoma (unresectable). Staging is based on AJCC Cancer Staging System 8th edition). The patients with advanced melanoma with available comprehensive NGS report are included in cohort 4.

• Willingness to provide archival or newly obtained tumor tissues for this study proposal

• Life expectancy more than 3 months -

• Patients fully understand the protocol with the willingness to have regular follow-up

Locations
Other Locations
Taiwan
CHANG GUNG MEMORIAL HOSPITAL, Chiayi
RECRUITING
Chiayi City
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Medical University
RECRUITING
Kaohsiung City
National Taiwan University Hospital ,NTUH Hsin-Chu Branch
RECRUITING
Sindian City
China Medical University Hospital
RECRUITING
Taichung
Chung Shan Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
Koo Foundation Sun Yat-Sen Cancer Center
RECRUITING
Taipei
MacKay Memorial Hospital
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Wan Fang Hospital, Taipei Medical University
RECRUITING
Taipei
CHANG GUNG MEMORIAL HOSPITAL, Linkou
RECRUITING
Taoyuan District
Taoyuan General Hospital, Ministry of Health and Welfare
RECRUITING
Taoyuan District
Contact Information
Primary
Chien-Ya Hung, BS
951106@nhri.edu.tw
+886-3-7206166
Time Frame
Start Date: 2022-08-22
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 250
Treatments
Cohort 1
(early acral melanoma): melanoma stage I/II
Cohort 2
(locally advanced acral melanoma): melanoma, stage III, resectable
Cohort 3
(advanced): unresectable / metastatic melanoma, stage III/IV or recurrent melanoma (unresectable). Staging is based on AJCC Cancer Staging System 8th edition).
Cohort 4
The patients with advanced melanoma with available comprehensive NGS report are included in cohort
Related Therapeutic Areas
Sponsors
Leads: National Health Research Institutes, Taiwan

This content was sourced from clinicaltrials.gov