The Registry Study of Genetic Alterations of Melanoma in Taiwan

Recruiting now

Conditions studied: Primary Melanoma of the Extremity

In brief

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.

Key facts

Study ID

NCT06952400

Run by

National Health Research Institutes, Taiwan

People needed

250

Starts

2022-08-22

Expected to finish

2030-12-31

Last updated by the study team

2025-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Inability to cooperate by providing a complete medical history
• No available tumor tissues for genetic testing (archived tissue sampling more than 5 years from screening date)
• Undesirable compliance (Mental status is not fit for further treatment or data collection.)

Where it is running

• Taipei Veterans General Hospital — Taipei, Taiwan/Taipei, Taiwan (enrolling)
• CHANG GUNG MEMORIAL HOSPITAL, Chiayi — Chiayi City, Taiwan (enrolling)
• Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (enrolling)
• Kaohsiung Medical University — Kaohsiung City, Taiwan (enrolling)
• National Taiwan University Hospital ,NTUH Hsin-Chu Branch — Sindian City, Taiwan (enrolling)
• China Medical University Hospital — Taichung, Taiwan (enrolling)
• Chung Shan Medical University Hospital — Taichung, Taiwan (enrolling)
• Taichung Veterans General Hospital — Taichung, Taiwan (enrolling)
• National Cheng Kung University Hospital — Tainan, Taiwan (enrolling)
• Koo Foundation Sun Yat-Sen Cancer Center — Taipei, Taiwan (enrolling)
• MacKay Memorial Hospital — Taipei, Taiwan (enrolling)
• National Taiwan University Hospital — Taipei, Taiwan (enrolling)
• Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital — Taipei, Taiwan (enrolling)
• Wan Fang Hospital, Taipei Medical University — Taipei, Taiwan (enrolling)
• CHANG GUNG MEMORIAL HOSPITAL, Linkou — Taoyuan, Taiwan (enrolling)
• Taoyuan General Hospital, Ministry of Health and Welfare — Taoyuan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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