Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia
MASTERKEY ASIA
A Prospective Clinical Registry Study of Genetic Profiling and Targeted Therapies in Patients With Rare Cancers in ASIA
2 other identifiers
observational
1,000
7 countries
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2021
CompletedStudy Start
First participant enrolled
November 30, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2030
March 22, 2024
March 1, 2024
5.3 years
October 24, 2021
March 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall incidence of any genomic alteration in overall population
Overall incidence of any genomic alteration in overall population
1 year
Overall incidence of any genomic alteration in patients with a certain cancer type
Overall incidence of any genomic alteration in patients with a certain cancer type
1 year
Secondary Outcomes (2)
Incidence of individual genomic alteration in overall population
1 year
Incidence of individual genomic alteration in patients with a certain cancer type
1 year
Other Outcomes (13)
Biomarker positive proportion in overall population
1 year
Biomarker positive proportion in patients with a certain cancer type
1 year
Number of somatic variants within exons in overall population
1 year
- +10 more other outcomes
Study Arms (2)
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.
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.)
- Patients with Advanced stage cancer.
You may not qualify if:
- \. Patients with complications of cognitive impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
National Cancer Center Hospital, Japan
Chuo-ku, Tokyo, 104-0045, Japan
Hospital Sultan Ismail
Johor Bahru, Johor, Malaysia
Hospital Pulau Pinang
Pulau Pinang, Pulau Pinang, Malaysia
Sarawak General Hospital
Kuching, Sarawak, 93586, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Center
Kuala Lumpur, Malaysia
Institut Kanser negara
Putrajaya, 62250, Malaysia
St. Luke's Medical Center
Manila, 1102, Philippines
National Cancer Center Korea
Seoul, South Korea
National Taiwan University Hospital
Taipei, Zhongzheng, 100225, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Mahidol University by Faculty of Medicine, Ramathibodi Hospita
Bangkok, Thailand
Mahidol University by Faculty of Medicine, Siriraj Hospital
Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Faculty of Medicine, Prince of Songkla University
Hat Yai, Thailand
Khon Kaen University by Faculty of Medicine, Srinagarind Hospital
Khon Kaen, Thailand
National Cancer Vietnam
Hanoi, Vietnam
Ho Chi Minh City Oncology Hospital
Ho Chi Minh City, Vietnam
Related Publications (1)
Okuma HS, Yonemori K, Narita SN, Sukigara T, Hirakawa A, Shimizu T, Shibata T, Kawai A, Yamamoto N, Nakamura K, Nishida T, Fujiwara Y. MASTER KEY Project: Powering Clinical Development for Rare Cancers Through a Platform Trial. Clin Pharmacol Ther. 2020 Sep;108(3):596-605. doi: 10.1002/cpt.1817. Epub 2020 Apr 7.
PMID: 32112563BACKGROUND
Biospecimen
whole blood, tissue
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2021
First Posted
February 1, 2022
Study Start
November 30, 2021
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2030
Last Updated
March 22, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share