Recruiting

NCT Number: NCT06952400

The Registry Study of Genetic Alterations of Melanoma in Taiwan

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.

Recruiting

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Key information

Conditions

Primary Melanoma of the Extremity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Veterans General Hospital, Taipei, Taiwan/Taipei, Taiwan

About this study

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 and lymph node dissection are the main treatment for patients with locally advanced melanoma. Adjuvant therapy should be considered for stage III melanoma. Unfortunately, most patients recur after above aggressive treatment. Systemic treatment including targeted therapy, immunotherapy and chemotherapy is the main for unresectable or metastatic melanoma. The prognosis of these patients remains poor with a median survival time around a year. Therefore, a better understanding of this deadly disease is crucial and finding better therapeutic strategies for these patients and stratifying patients with suitable treatment are urgent.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.)

Treatment and study plan

Primary outcomes

To evaluate the evolution of acral melanoma patients in Taiwan.

Time frame: Duration of Enrollment: 2022/10-2025/12
- Collecting the tissues from melanoma patients for NGS studies, One H&E staining slide, and 10 tissue slides (4-5 um thickness) for cancer panel-based next generation sequencing analysis, including fusion panel (10 slides) will be required (first priority).
- Non-tumor Sample (Blood): Fifteen (15) ml of blood will be collected from the participant: 7 ml in EDTA tube (purple top) and 8 ml in Cell-Free DNA blood collection tube. These blood samples will be separated into peripheral blood mononuclear cells and plasma specimens for germline mutation analysis and potential biomarker study, respectively.
- Non-tumor Sample (Stool for microbiota):Collecting stool specimens before systemic treatment (for prospective cohort), 2-3 months after initiating targeted therapy or immunotherapy. IHC staining for specific biomarkers such as MDM2 and HER2 will be evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

Chien-Ya Hung, BS

CONTACT

[email protected]

+886-3-7206166 ext. 35104

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Registry information

Official study title

T1622 The Registry Study of Genetic Alterations of Melanoma in Taiwan

Acronym: Melanoma

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2030
First posted: Apr 30, 2025
Registry last updated: May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.