RecruitingNCT06952400

The Registry Study of Genetic Alterations of Melanoma in Taiwan

T1622 The Registry Study of Genetic Alterations of Melanoma in Taiwan


Sponsor

National Health Research Institutes, Taiwan

Enrollment

250 participants

Start Date

Aug 22, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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

Exclusion Criteria3

  • 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.)

Locations(16)

Taipei Veterans General Hospital

Taipei, Taiwan/Taipei, Taiwan

CHANG GUNG MEMORIAL HOSPITAL, Chiayi

Chiayi City, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Medical University

Kaohsiung City, Taiwan

National Taiwan University Hospital ,NTUH Hsin-Chu Branch

Sindian City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital

Taipei, Taiwan

Wan Fang Hospital, Taipei Medical University

Taipei, Taiwan

CHANG GUNG MEMORIAL HOSPITAL, Linkou

Taoyuan District, Taiwan

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan District, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06952400