Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia (MASTERKEY ASIA)

March 20, 2024 updated by: National Cancer Center, Japan

A Prospective Clinical Registry Study of Genetic Profiling and Targeted Therapies in Patients With Rare Cancers in ASIA

This is a registry study that aims to collect patients' data with advanced-stage rare cancer in Asia-Pacific region. Data includes clinical information, details of treatment, prognosis, pathological diagnosis and genetic biomarkers by next-generation sequencing.

The relationship between cancer types and prognosis, the effect of treatments, and the cancer type-specific incidence of genomic alterations will be investigated to discover more specific and effective treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

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 Backup

Study Locations

  • Japan
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital, Japan
        • Contact:
          • Chiharu Mizoguchi, MD
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • National Cancer Center Korea
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Hospital Kuala Lumpur
      • Kuala Lumpur, Malaysia
        • Recruiting
        • University Malaya Medical Center
      • Putrajaya, Malaysia, 62250
        • Recruiting
        • Institut Kanser Negara
    • Johor
      • Johor Bahru, Johor, Malaysia
        • Recruiting
        • Hospital Sultan Ismail
    • Penang
      • Pulau Pinang, Penang, Malaysia
        • Recruiting
        • Hospital Pulau Pinang
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Sarawak General Hospital
  • Philippines
      • Manila, Philippines, 1102
        • Recruiting
        • St. Luke's Medical Center
  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital
    • Zhongzheng
      • Taipei, Zhongzheng, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
  • Thailand
      • Bangkok, Thailand
        • Recruiting
        • Mahidol University by Faculty of Medicine, Ramathibodi Hospita
      • Bangkok, Thailand
        • Recruiting
        • Mahidol University by Faculty of Medicine, Siriraj Hospital
      • Chiang Mai, Thailand
        • Not yet recruiting
        • Maharaj Nakorn Chiang Mai Hospital
      • Hat Yai, Thailand
        • Recruiting
        • Faculty of Medicine, Prince of Songkla University
      • Khon Kaen, Thailand
        • Recruiting
        • Khon Kaen University by Faculty of Medicine, Srinagarind Hospital
  • Vietnam
      • Hanoi, Vietnam
        • Recruiting
        • National Cancer Vietnam
      • Ho Chi Minh City, Vietnam
        • Not yet recruiting
        • Ho Chi Minh City Oncology Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Malignancies with an annual incidence of less than 6 cases per 100,000 population; malignancies categorized as rare cancers in the European RARECARE report; malignancies that are difficult to develop treatments; common cancers with rare tissue subtypes; common cancers that can be regarded as rare based on biological demographics such as age or sex; and cancers of unknow primary are eligible for this study.

Description

Inclusion Criteria:

  1. Patients with a histological diagnosis of rare cancer, cancer of unknown primary origin, or cancer of rare tissue subtypes of common cancers. (Defined in protocol.)
  2. Patients with Advanced stage cancer.

Exclusion Criteria:

1. Patients with complications of cognitive impairment.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rare cancer
Malignancies with an annual incidence of less than 6 cases per 100,000 population; malignancies categorized as rare cancers in the European RARECARE report; malignancies that are difficult to develop treatments; common cancers with rare tissue subtypes; common cancers that can be regarded as rare based on biological demographics such as age or sex; and cancers of unknow primary are eligible for this study.
Other: Genomic sequence
Genomic sequence
Cholangiocarcinoma cohort
This study is a part of MASTER KEY Asia study and designed to be conducted on the patients of cholangiocarcinoma only. The primary endpoint is assigned to the frequency of FGFR2 fusion gene positive cholangiocarcinoma detected by fluorescence in situ hybridization (FISH) in Asian countries. The genetic analysis is performed not only by FISH, but also by next generation sequencing (NGS), so that genetic alterations other than the FGFR2 fusion gene in alterations can be confirmed. To improve outcomes, collecting clinical information is very important to study the relationship between genetic alterations and prognosis, effect of treatments, and the incidence of genomic alterations in cholangiocarcinoma to discover more specific and effective treatment.
Other: Genomic sequence
Genomic sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall incidence of any genomic alteration in overall population
Time Frame: 1 year
Overall incidence of any genomic alteration in overall population
1 year
Overall incidence of any genomic alteration in patients with a certain cancer type
Time Frame: 1 year
Overall incidence of any genomic alteration in patients with a certain cancer type
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of individual genomic alteration in overall population
Time Frame: 1 year
The incidence of individual genomic alterations in overall population
1 year
Incidence of individual genomic alteration in patients with a certain cancer type
Time Frame: 1 year
The incidence of individual genomic alterations in patients with a certain cancer type
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker positive proportion in overall population
Time Frame: 1 year
The proportion of patients positive for certain biomarkers in overall population
1 year
Biomarker positive proportion in patients with a certain cancer type
Time Frame: 1 year
The proportion of patients positive for certain biomarkers in patients with a certain cancer type
1 year
Number of somatic variants within exons in overall population
Time Frame: 1 year
The number of somatic variants and proportion of variants in overall population
1 year
Number of somatic variants within exons in patients with a certain cancer type
Time Frame: 1 year
The number of somatic variants and proportion of variants in patients with a certain cancer type
1 year
Response rate in patients treated with biomarker/genomic alteration-based therapy
Time Frame: 1 year
Response rate in patients treated with biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.
1 year
Response rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy
Time Frame: 1 year
Response rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.
1 year
Response rate in patients treated with immune checkpoint inhibitors
Time Frame: 1 year
Response rate in patients treated with immune checkpoint inhibitors in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.
1 year
Disease control rate in patients treated with biomarker/genomic alteration-based therapy
Time Frame: 1 year
Disease control rate in patients treated with biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.
1 year
Disease control rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy
Time Frame: 1 year
Disease control rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.
1 year
Disease control rate in patients treated with immune checkpoint inhibitors
Time Frame: 1 year
Disease control rate in patients treated with immune checkpoint inhibitors in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.
1 year
Overall survival
Time Frame: 1 year
Overall survival in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.
1 year
Progression-free survival
Time Frame: 1 year
Progression-free survival in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.
1 year
Proportion of patients receiving no treatment with observation-only in real-world clinical practice
Time Frame: 1 year
Proportion of patients receiving no treatment with observation-only in real-world clinical practice in overall population & in patients with a certain cancer type. Proportion of patients receiving no treatment or observation with best supportive care in real-world clinical practice in overall population & in patients with a certain cancer type.
1 year

Collaborators and Investigators

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

Sponsor

National Cancer Center, Japan

Investigators

  • Principal Investigator: Noboru Yamamoro, MD, PhD, National Cancer Center Hospital, Japan
  • Study Director: Kan Yonemori, MD, PhD, National Cancer Center Hospital, Japan
  • Study Director: Kenichi Nakamura, MD, PhD, National Cancer Center Hospital, Japan
  • Study Director: Yuta Maruki, MD, National Cancer Center Hospital, Japan
  • Principal Investigator: Takuji Okusaka, MD, PhD, National Cancer Center Hospital, Japan

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)

November 30, 2021

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

October 24, 2021

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCH2007
  • 20lk0201002j0001 (Other Grant/Funding Number: AMED)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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