The Registry Study of Genetic Alterations of Melanoma in Taiwan
NCT ID: NCT06952400
Last Updated: 2025-05-06
Study Results
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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RECRUITING
250 participants
OBSERVATIONAL
2022-08-22
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
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.)
18 Years
ALL
Yes
Sponsors
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National Health Research Institutes, Taiwan
OTHER
Responsible Party
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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
CHANG GUNG MEMORIAL HOSPITAL, Chiayi
Chiayi City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Medical University
Kaohsiung City, , Taiwan
National Taiwan University Hospital ,NTUH Hsin-Chu Branch
Sindian City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, , Taiwan
MacKay Memorial Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital
Taipei, , Taiwan
Wan Fang Hospital, Taipei Medical University
Taipei, , Taiwan
CHANG GUNG MEMORIAL HOSPITAL, Linkou
Taoyuan District, , Taiwan
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan District, , Taiwan
Countries
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Central Contacts
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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.
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.
Other Identifiers
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T1622
Identifier Type: -
Identifier Source: org_study_id
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