NCT06952400 The Registry Study of Genetic Alterations of Melanoma in Taiwan
| NCT ID | NCT06952400 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Health Research Institutes, Taiwan |
| Condition | Primary Melanoma of the Extremity |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-08-22 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2022-08-22 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: 1. Age \> 18 years old 2. Pathologically confirmed melanoma. (Patients with additional malignancies requiring treatment or follow-up are allowed. Only treatment for melanoma should be recorded). 3. ECOG performance status \< 3 4. 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. 5. Willingness to provide archival or newly obtained tumor tissues for this study proposal 6. Life expectancy more than 3 months - 7. Patients fully understand the protocol with the willingness to have regular follow-up Exclusion Criteria: 1. Inability to cooperate by providing a complete medical history 2. No available tumor tissues for genetic testing (archived tissue sampling more than 5 years from screening date) 3. Undesirable compliance (Mental status is not fit for further treatment or data collection.)
Contact & Investigator
Chiao-En Wu, MD, PhD
PRINCIPAL INVESTIGATOR
Chang Gung Medical Foundation
Frequently Asked Questions
Who can join the NCT06952400 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Melanoma of the Extremity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06952400 currently recruiting?
Yes, NCT06952400 is actively recruiting participants. Contact the research team at 951106@nhri.edu.tw for enrollment information.
Where is the NCT06952400 trial being conducted?
This trial is being conducted at Taipei, Taiwan, Chiayi City, Taiwan, Kaohsiung City, Taiwan, Kaohsiung City, Taiwan and 11 additional locations.
Who is sponsoring the NCT06952400 clinical trial?
NCT06952400 is sponsored by National Health Research Institutes, Taiwan. The principal investigator is Chiao-En Wu, MD, PhD at Chang Gung Medical Foundation. The trial plans to enroll 250 participants.
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