Registry of Genetic Changes in Melanoma in Taiwan
T1622 The Registry Study of Genetic Alterations of Melanoma in Taiwan
This study is trying to learn more about the genetic changes in different types of melanoma, especially those more common in Taiwan, to help improve treatment and outcomes for patients with this skin cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Health Research Institutes, Taiwan Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 16 sites (Taipei, Taiwan/Taipei and 15 other locations) |
| Trial ID | NCT06952400 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on genetic alterations in various types of melanoma, particularly focusing on acral and mucosal melanoma, which are more prevalent in Taiwan compared to Caucasian populations. It will involve patients aged over 18 with pathologically confirmed melanoma, who will provide tumor tissue samples for analysis. The study seeks to understand the unique epidemiological and genetic features of melanoma in Taiwan to improve treatment strategies and patient outcomes. By comparing these findings with existing data from Western populations, the study aims to address the high recurrence rates and poor survival outcomes observed in Taiwanese melanoma patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with pathologically confirmed melanoma at various stages, willing to provide tumor tissue samples.
Not a fit: Patients with non-melanoma skin cancers or those unable to provide tumor tissue samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved therapeutic strategies and better outcomes for melanoma patients in Taiwan.
How similar studies have performed: While there is limited data on similar studies specifically in Taiwan, research on genetic alterations in melanoma has shown promise in other populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Taipei, Taiwan/Taipei and 15 other locations
- Taipei Veterans General Hospital — Taipei, Taiwan/Taipei, Taiwan (Recruiting)
- CHANG GUNG MEMORIAL HOSPITAL, Chiayi — Chiayi City, Taiwan (Recruiting)
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
- Kaohsiung Medical University — Kaohsiung City, Taiwan (Recruiting)
- National Taiwan University Hospital ,NTUH Hsin-Chu Branch — Sindian City, Taiwan (Recruiting)
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
- Chung Shan Medical University Hospital — Taichung, Taiwan (Recruiting)
- Taichung Veterans General Hospital — Taichung, Taiwan (Recruiting)
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
- Koo Foundation Sun Yat-Sen Cancer Center — Taipei, Taiwan (Recruiting)
- MacKay Memorial Hospital — Taipei, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital — Taipei, Taiwan (Recruiting)
- Wan Fang Hospital, Taipei Medical University — Taipei, Taiwan (Recruiting)
- CHANG GUNG MEMORIAL HOSPITAL, Linkou — Taoyuan, Taiwan (Recruiting)
- Taoyuan General Hospital, Ministry of Health and Welfare — Taoyuan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chiao-En Wu, MD, PhD — Chang Gung Medical Foundation
- Study coordinator: Chien-Ya Hung, BS
- Email: 951106@nhri.edu.tw
- Phone: +886-3-7206166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.