Primary Melanoma of the ExtremityMelanomaNCT06952400
The Registry Study of Genetic Alterations of Melanoma in Taiwan
An observational study of Primary Melanoma of the Extremity, run by National Health Research Institutes, Taiwan at 16 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Melanoma of the Extremity
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 16 sitesTaiwan
- Study dates
- 22 Aug 2022to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- Willingness to provide archival or newly obtained tumor tissues for this study proposal
- Life expectancy more than 3 months -
- Patients fully understand the protocol with the willingness to have regular follow-up
Who cannot join
- 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 locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Taiwan16 sites, 16 recruiting
- Recruiting
CHANG GUNG MEMORIAL HOSPITAL, Chiayi
Chiayi City
FENG-CHE KUAN
FENG-CHE KUAN
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Yen-Hao Chen
Yen-Hao Chen
- Recruiting
Kaohsiung Medical University
Kaohsiung City
Hui-Hua Hsiao
Hui-Hua Hsiao
- Recruiting
National Taiwan University Hospital ,NTUH Hsin-Chu Branch
Sindian City
Jih-Hsiang Lee
Jih-Hsiang Lee
- Recruiting
China Medical University Hospital
Taichung
Chen-Yuan Lin
Chen-Yuan Lin
- Recruiting
Chung Shan Medical University Hospital
Taichung
Ming-Fang Wu
Ming-Fang Wu
- Recruiting
Taichung Veterans General Hospital
Taichung
Young-sen Yang
Young-sen Yang
- Recruiting
National Cheng Kung University Hospital
Tainan
Chia-Jui Yen
Chia-Jui Yen
- Recruiting
Taipei Veterans General Hospital
Taipei, Taiwan/Taipei
Chuan-Yen Chueh
Chuan-Yen Chueh
- Recruiting
Koo Foundation Sun Yat-Sen Cancer Center
Taipei
Hsiao-Hsiang Cheng
Hsiao-Hsiang Cheng
- Recruiting
MacKay Memorial Hospital
Taipei
Yi-Fang Chang
Yi-Fang Chang
- Recruiting
National Taiwan University Hospital
Taipei
Chia-Chi Lin
Chia-Chi Lin
- Recruiting
Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital
Taipei
Yao-Yu Hsieh
Yao-Yu Hsieh
- Recruiting
Wan Fang Hospital, Taipei Medical University
Taipei
Chia-Lun Chang
Chia-Lun Chang
- Recruiting
CHANG GUNG MEMORIAL HOSPITAL, Linkou
Taoyuan
Wen-Cheng Chang
Wen-Cheng Chang
- Recruiting
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan
Yuan-Hao Yang
Yuan-Hao Yang
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Melanoma of the Extremity
- Keywords
- next-generation sequencing, acral melanoma, mucosal melanoma, cutaeous melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of Enrollment: 2022/10-2025/12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start22 Aug 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Primary Melanoma of the ExtremityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiao-En Wu, MD, PhD, Principal investigator, Chang Gung Medical FoundationTsang-Wu Liu, MD, Study chair, Taiwan Cooperative Oncology Group,National Health Research Institutes, TaiwanNai-Jung Chiang, MD, PhD, Principal investigator, Taiwan Cooperative Oncology Group,National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952400
- Sponsor's protocol ID
- T1622
- Acronym
- Melanoma
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35020204Chang 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.
PubMed 31814762Hayward 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.
PubMed 28467829Newell 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.
PubMed 33067454Newell 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.
PubMed 31320640Sheen 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.
PubMed 31408190Chang 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.
PubMed 28198155Wu 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.
PubMed 32582554
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T1622 The Registry Study of Genetic Alterations of Melanoma in Taiwan
- ClinicalTrials.gov ID
- NCT06952400
- Acronym / sponsor ID
- Melanoma / T1622
- Conditions
- Primary Melanoma of the Extremity
- Keywords
- next-generation sequencing, acral melanoma, mucosal melanoma, cutaeous melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- Willingness to provide archival or newly obtained tumor tissues for this study proposal
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the evolution of acral melanoma patients in Taiwan.
Time frame: Duration of Enrollment: 2022/10-2025/12
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Results publication: PubMed 35020204Siegel 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.
- Results publication: PubMed 31814762Chang 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.
- Results publication: PubMed 28467829Hayward 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.
- Results publication: PubMed 33067454Newell 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.
- Results publication: PubMed 31320640Newell 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.
- Results publication: PubMed 31408190Sheen 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.
- Results publication: PubMed 28198155Chang 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.
- Results publication: PubMed 32582554Wu 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chiao-En Wu, MD, PhD principal investigator
Chang Gung Medical Foundation
Tsang-Wu Liu, MD study chair
Taiwan Cooperative Oncology Group,National Health Research Institutes, Taiwan
Nai-Jung Chiang, MD, PhD principal investigator
Taiwan Cooperative Oncology Group,National Health Research Institutes, Taiwan
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Melanoma of the Extremity, run by National Health Research Institutes, Taiwan at 16 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chien-Ya Hung, BS (+886-3-7206166 ext. 35104, 951106@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the evolution of acral melanoma patients in Taiwan. (time frame: Duration of Enrollment: 2022/10-2025/12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06952400, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.