The Registry Study of Genetic Alterations of Melanoma in Taiwan

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Health Research Institutes, Taiwan

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.)

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 4 trial groups
Group A: Cohort 1
Group B: Cohort 2
Group C: Cohort 3
Group D: Cohort 4

Trial outcomes

Primary outcomes

1

To evaluate the evolution of acral melanoma patients in Taiwan.

1. 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). 2. 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. 3. 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.

Time frame
Duration of Enrollment: 2022/10-2025/12

Secondary outcomes

Other outcomes

Sponsors and contacts

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