The Registry Study of Genetic Alterations of Melanoma in Taiwan

NCT ID: NCT06952400

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-22

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Primary Melanoma of the Extremity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Cohort 1

(early acral melanoma): melanoma stage I/II

No interventions assigned to this group

Cohort 2

(locally advanced acral melanoma): melanoma, stage III, resectable

No interventions assigned to this group

Cohort 3

(advanced): unresectable / metastatic melanoma, stage III/IV or recurrent melanoma (unresectable). Staging is based on AJCC Cancer Staging System 8th edition).

No interventions assigned to this group

Cohort 4

The patients with advanced melanoma with available comprehensive NGS report are included in cohort

No interventions assigned to this group

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chiao-En Wu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Medical Foundation

Tsang-Wu Liu, MD

Role: STUDY_CHAIR

Taiwan Cooperative Oncology Group,National Health Research Institutes, Taiwan

Nai-Jung Chiang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taiwan Cooperative Oncology Group,National Health Research Institutes, Taiwan

Locations

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Taipei Veterans General Hospital

Taipei, Taiwan/Taipei, Taiwan

Site Status RECRUITING

CHANG GUNG MEMORIAL HOSPITAL, Chiayi

Chiayi City, , Taiwan

Site Status RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Kaohsiung Medical University

Kaohsiung City, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital ,NTUH Hsin-Chu Branch

Sindian City, , Taiwan

Site Status RECRUITING

China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status RECRUITING

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, , Taiwan

Site Status RECRUITING

MacKay Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital

Taipei, , Taiwan

Site Status RECRUITING

Wan Fang Hospital, Taipei Medical University

Taipei, , Taiwan

Site Status RECRUITING

CHANG GUNG MEMORIAL HOSPITAL, Linkou

Taoyuan District, , Taiwan

Site Status RECRUITING

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chien-Ya Hung, BS

Role: CONTACT

+886-3-7206166 ext. 35104

Facility Contacts

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Chuan-Yen Chueh

Role: primary

FENG-CHE KUAN

Role: primary

Yen-Hao Chen

Role: primary

Hui-Hua Hsiao

Role: primary

Jih-Hsiang Lee

Role: primary

Chen-Yuan Lin

Role: primary

Ming-Fang Wu

Role: primary

Young-sen Yang

Role: primary

Chia-Jui Yen

Role: primary

Hsiao-Hsiang Cheng

Role: primary

Yi-Fang Chang

Role: primary

Chia-Chi Lin

Role: primary

Yao-Yu Hsieh

Role: primary

Chia-Lun Chang

Role: primary

Wen-Cheng Chang

Role: primary

Yuan-Hao Yang

Role: primary

References

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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.

Reference Type RESULT
PMID: 32582554 (View on PubMed)

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.

Reference Type RESULT
PMID: 35020204 (View on PubMed)

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.

Reference Type RESULT
PMID: 31814762 (View on PubMed)

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.

Reference Type RESULT
PMID: 28467829 (View on PubMed)

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.

Reference Type RESULT
PMID: 33067454 (View on PubMed)

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.

Reference Type RESULT
PMID: 31320640 (View on PubMed)

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.

Reference Type RESULT
PMID: 31408190 (View on PubMed)

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.

Reference Type RESULT
PMID: 28198155 (View on PubMed)

Other Identifiers

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T1622

Identifier Type: -

Identifier Source: org_study_id

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