Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the evolution of acral melanoma patients in Taiwan. |
| Duration of Enrollment: 2022/10-2025/12 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chien-Ya Hung, BS | Contact | +886-3-7206166 | 35104 | 951106@nhri.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Chiao-En Wu, MD, PhD | Chang Gung Medical Foundation | Principal Investigator |
| Tsang-Wu Liu, MD | Taiwan Cooperative Oncology Group,National Health Research Institutes, Taiwan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Recruiting | Taipei | Taiwan/Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35020204 | Result | 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. | |
| 31814762 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Tumor Sample(s):
One H&E staining slide, and 10 tissue slides for cancer panel-based next generation sequencing analysis, including fusion panel will be required (first priority).
The other one H&E staining slide and 5 slides (4-5 um thickness) will be lab for RNA extraction (optional, operative tissue was favored). IHC for possible biomarkers (including MDM2/HER2): one H&E staining slide and 5 slides.
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.
Non-tumor Sample (Stool for microbiota): Fecal sample preparation and sequencing will be performed at CGMH. 16S rRNA gene sequencing will be performed.
| Nai-Jung Chiang, MD, PhD |
| Taiwan Cooperative Oncology Group,National Health Research Institutes, Taiwan |
| Principal Investigator |
| CHANG GUNG MEMORIAL HOSPITAL, Chiayi | Recruiting | Chiayi City | Taiwan |
|
| Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | Taiwan |
|
| Kaohsiung Medical University | Recruiting | Kaohsiung City | Taiwan |
|
| National Taiwan University Hospital ,NTUH Hsin-Chu Branch | Recruiting | Sindian City | Taiwan |
|
| China Medical University Hospital | Recruiting | Taichung | Taiwan |
|
| Chung Shan Medical University Hospital | Recruiting | Taichung | Taiwan |
|
| Taichung Veterans General Hospital | Recruiting | Taichung | Taiwan |
|
| National Cheng Kung University Hospital | Recruiting | Tainan | Taiwan |
|
| Koo Foundation Sun Yat-Sen Cancer Center | Recruiting | Taipei | Taiwan |
|
| MacKay Memorial Hospital | Recruiting | Taipei | Taiwan |
|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
|
| Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital | Recruiting | Taipei | Taiwan |
|
| Wan Fang Hospital, Taipei Medical University | Recruiting | Taipei | Taiwan |
|
| CHANG GUNG MEMORIAL HOSPITAL, Linkou | Recruiting | Taoyuan | Taiwan |
|
| Taoyuan General Hospital, Ministry of Health and Welfare | Recruiting | Taoyuan | Taiwan |
|
| 28467829 | Result | 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. |
| 33067454 | Result | 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. |
| 31320640 | Result | 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. |
| 31408190 | Result | 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. |
| 28198155 | Result | 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. |
| 32582554 | Result | 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. |