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

May 1, 2025 updated by: National Health Research Institutes, Taiwan

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Duration of Enrollment: 2022/10-2025/12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Health Research Institutes, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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