The Registry Study of Genetic Alterations of Melanoma in Taiwan (Melanoma)

T1622 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.

Study Overview

• Status: Recruiting
• Conditions: Primary Melanoma of the Extremity

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 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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Chien-Ya Hung, BS; Phone Number: 35104 +886-3-7206166; Email: 951106@nhri.edu.tw

Study Locations

• Taiwan
  • Chiayi City, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital, Chiayi
    • Principal Investigator: FENG-CHE KUAN
    • Contact: FENG-CHE KUAN
  • Kaohsiung, Taiwan
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
    • Contact: Yen-Hao Chen
    • Principal Investigator: Yen-Hao Chen
  • Kaohsiung city, Taiwan
    • Recruiting
    • Kaohsiung Medical University
    • Contact: Hui-Hua Hsiao
    • Principal Investigator: Hui-Hua Hsiao
  • Sindian City, Taiwan
    • Recruiting
    • National Taiwan University Hospital ,NTUH Hsin-Chu Branch
    • Principal Investigator: Jih-Hsiang Lee
    • Contact: Jih-Hsiang Lee
  • Taichung, Taiwan
    • Recruiting
    • China Medical University Hospital
    • Principal Investigator: Chen-Yuan Lin
    • Contact: Chen-Yuan Lin
  • Taichung, Taiwan
    • Recruiting
    • Taichung Veterans General Hospital
    • Contact: Young-sen Yang
    • Principal Investigator: Young-sen Yang
  • Taichung, Taiwan
    • Recruiting
    • Chung Shan Medical University Hospital
    • Contact: Ming-Fang Wu
    • Principal Investigator: Ming-Fang Wu
  • Tainan, Taiwan
    • Recruiting
    • National Cheng Kung University Hospital
    • Contact: Chia-Jui Yen
    • Principal Investigator: Chia-Jui Yen
  • Taipei, Taiwan
    • Recruiting
    • Mackay Memorial Hospital
    • Contact: Yi-Fang Chang
    • Principal Investigator: Yi-Fang Chang
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chia-Chi Lin
    • Principal Investigator: Chia-Chi Lin
  • Taipei, Taiwan
    • Recruiting
    • Koo Foundation Sun Yat-Sen Cancer Center
    • Principal Investigator: Hsiao-Hsiang Cheng
    • Contact: Hsiao-Hsiang Cheng
  • Taipei, Taiwan
    • Recruiting
    • Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital
    • Contact: Yao-Yu Hsieh
    • Principal Investigator: Yao-Yu Hsieh
  • Taipei, Taiwan
    • Recruiting
    • Wan Fang Hospital, Taipei Medical University
    • Contact: Chia-Lun Chang
    • Principal Investigator: Chia-Lun Chang
  • Taoyuan, Taiwan
    • Recruiting
    • Taoyuan General Hospital, Ministry of Health and Welfare
    • Contact: Yuan-Hao Yang
    • Principal Investigator: Yuan-Hao Yang
  • Taoyuan, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital, Linkou
    • Contact: Wen-Cheng Chang
    • Principal Investigator: Wen-Cheng Chang
  • Taiwan/Taipei
    • Taipei, Taiwan/Taipei, Taiwan
      • Recruiting
      • Taipei Veterans General Hospital
      • Contact: Chuan-Yen Chueh
      • Principal Investigator: Chuan-Yen Chueh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study 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.

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Cohort 1; (early acral melanoma): melanoma stage I/II
Cohort 2; (locally advanced acral melanoma): melanoma, stage III, resectable
Cohort 3; (advanced): unresectable / metastatic melanoma, stage III/IV or recurrent melanoma (unresectable). Staging is based on AJCC Cancer Staging System 8th edition).
Cohort 4; The patients with advanced melanoma with available comprehensive NGS report are included in cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the evolution of acral melanoma patients in Taiwan.	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.	Duration of Enrollment: 2022/10-2025/12

Collaborators and Investigators

• Sponsor: National Health Research Institutes, Taiwan
• Investigators: Principal Investigator: Chiao-En Wu, MD, PhD, Chang Gung Medical Foundation; Study Chair: Tsang-Wu Liu, MD, Taiwan Cooperative Oncology Group,National Health Research Institutes, Taiwan; Principal Investigator: Nai-Jung Chiang, MD, PhD, Taiwan Cooperative Oncology Group,National Health Research Institutes, Taiwan

Publications and helpful links

General Publications

• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
• Chang JW, Huang YL, Chang YY, Lo YF, Ho TY, Huang YT, Chen HW, Wu CE. Sentinel Lymph Node Biopsy Was Associated With Favorable Survival Outcomes For Patients With Clinically Node-Negative Asian Melanoma. Cancer Manag Res. 2019 Nov 14;11:9655-9664. doi: 10.2147/CMAR.S227837. eCollection 2019.
• Hayward NK, Wilmott JS, Waddell N, Johansson PA, Field MA, Nones K, Patch AM, Kakavand H, Alexandrov LB, Burke H, Jakrot V, Kazakoff S, Holmes O, Leonard C, Sabarinathan R, Mularoni L, Wood S, Xu Q, Waddell N, Tembe V, Pupo GM, De Paoli-Iseppi R, Vilain RE, Shang P, Lau LMS, Dagg RA, Schramm SJ, Pritchard A, Dutton-Regester K, Newell F, Fitzgerald A, Shang CA, Grimmond SM, Pickett HA, Yang JY, Stretch JR, Behren A, Kefford RF, Hersey P, Long GV, Cebon J, Shackleton M, Spillane AJ, Saw RPM, Lopez-Bigas N, Pearson JV, Thompson JF, Scolyer RA, Mann GJ. Whole-genome landscapes of major melanoma subtypes. Nature. 2017 May 11;545(7653):175-180. doi: 10.1038/nature22071. Epub 2017 May 3.
• Newell F, Wilmott JS, Johansson PA, Nones K, Addala V, Mukhopadhyay P, Broit N, Amato CM, Van Gulick R, Kazakoff SH, Patch AM, Koufariotis LT, Lakis V, Leonard C, Wood S, Holmes O, Xu Q, Lewis K, Medina T, Gonzalez R, Saw RPM, Spillane AJ, Stretch JR, Rawson RV, Ferguson PM, Dodds TJ, Thompson JF, Long GV, Levesque MP, Robinson WA, Pearson JV, Mann GJ, Scolyer RA, Waddell N, Hayward NK. Whole-genome sequencing of acral melanoma reveals genomic complexity and diversity. Nat Commun. 2020 Oct 16;11(1):5259. doi: 10.1038/s41467-020-18988-3.
• Newell F, Kong Y, Wilmott JS, Johansson PA, Ferguson PM, Cui C, Li Z, Kazakoff SH, Burke H, Dodds TJ, Patch AM, Nones K, Tembe V, Shang P, van der Weyden L, Wong K, Holmes O, Lo S, Leonard C, Wood S, Xu Q, Rawson RV, Mukhopadhyay P, Dummer R, Levesque MP, Jonsson G, Wang X, Yeh I, Wu H, Joseph N, Bastian BC, Long GV, Spillane AJ, Shannon KF, Thompson JF, Saw RPM, Adams DJ, Si L, Pearson JV, Hayward NK, Waddell N, Mann GJ, Guo J, Scolyer RA. Whole-genome landscape of mucosal melanoma reveals diverse drivers and therapeutic targets. Nat Commun. 2019 Jul 18;10(1):3163. doi: 10.1038/s41467-019-11107-x.
• Sheen YS, Tan KT, Tse KP, Liao YH, Lin MH, Chen JS, Liau JY, Tseng YJ, Lee CH, Hong CH, Liao JB, Chang HT, Chu CY. Genetic alterations in primary melanoma in Taiwan. Br J Dermatol. 2020 May;182(5):1205-1213. doi: 10.1111/bjd.18425. Epub 2019 Oct 15.
• Chang JW, Guo J, Hung CY, Lu S, Shin SJ, Quek R, Ying A, Ho GF, Nguyen HS, Dhabhar B, Sriuranpong V, Tiambeng ML, Prayogo N, Yamazaki N. Sunrise in melanoma management: Time to focus on melanoma burden in Asia. Asia Pac J Clin Oncol. 2017 Dec;13(6):423-427. doi: 10.1111/ajco.12670. Epub 2017 Feb 15. No abstract available.
• Wu CE, Yang CK, Peng MT, Huang PW, Lin YF, Cheng CY, Chang YY, Chen HW, Hsieh JJ, Chang JW. Immune Checkpoint Inhibitors for Advanced Melanoma: Experience at a Single Institution in Taiwan. Front Oncol. 2020 Jun 4;10:905. doi: 10.3389/fonc.2020.00905. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 6, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: mucosal melanoma; next-generation sequencing; acral melanoma; cutaeous melanoma
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma
• Other Study ID Numbers: T1622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No