Status:
RECRUITING
The Registry Study of Genetic Alterations of Melanoma in Taiwan
Lead Sponsor:
National Health Research Institutes, Taiwan
Conditions:
Primary Melanoma of the Extremity
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
Most melanoma patients present with locally advanced or metastatic disease at diagnosis reflecting the aggressive disease nature of melanoma in Taiwan. Currently, surgical resection of primary tumor a...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
August 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06952400
Start Date
August 22 2022
End Date
December 31 2030
Last Update
May 6 2025
Active Locations (16)
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1
Taipei Veterans General Hospital
Taipei, Taiwan/Taipei, Taiwan
2
CHANG GUNG MEMORIAL HOSPITAL, Chiayi
Chiayi City, Taiwan
3
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
4
Kaohsiung Medical University
Kaohsiung City, Taiwan