Rare Malignant NeoplasmMASTERKEY ASIANCT05217407
Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia
An observational study of Rare Malignant Neoplasm, run by National Cancer Center, Japan at 18 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rare Malignant Neoplasm
- What is being tested?
- Genomic sequence
- How many people
- 1,000 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 30 Nov 2021to 31 Mar 2030
- How long will I take part?
- 3 Years
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 1. Patients with complications of cognitive impairment.
Trial locations and contacts
18 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 7 countries
Malaysia6 sites, 6 recruiting
- Recruiting
Hospital Sultan Ismail
Johor Bahru, Johor
- Recruiting
Hospital Kuala Lumpur
Kuala Lumpur, 50586
- Recruiting
University Malaya Medical Center
Kuala Lumpur
- Recruiting
Sarawak General Hospital
Kuching, Sarawak, 93586
- Recruiting
Hospital Pulau Pinang
Pulau Pinang, Pulau Pinang
- Recruiting
Institut Kanser negara
Putrajaya, 62250
Thailand5 sites, 5 recruiting
- Recruiting
Mahidol University by Faculty of Medicine, Ramathibodi Hospita
Bangkok
- Recruiting
Mahidol University by Faculty of Medicine, Siriraj Hospital
Bangkok
- Not yet recruiting
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
- Recruiting
Faculty of Medicine, Prince of Songkla University
Hat Yai
- Recruiting
Khon Kaen University by Faculty of Medicine, Srinagarind Hospital
Khon Kaen
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Zhongzheng, 100225
- Recruiting
Taipei Veterans General Hospital
Taipei
Vietnam2 sites, 2 recruiting
- Recruiting
National Cancer Vietnam
Hanoi
- Not yet recruiting
Ho Chi Minh City Oncology Hospital
Ho Chi Minh City
Japan1 site, 1 recruiting
- Recruiting
National Cancer Center Hospital, Japan
Chuo-ku, Tokyo, 104-0045
Chiharu Mizoguchi, MD
Philippines1 site, 1 recruiting
- Recruiting
St. Luke's Medical Center
Manila, 1102
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center Korea
Seoul
About this study
Official title: 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.
- Conditions
- Rare Malignant Neoplasm
- Being tested
- Genomic sequence
- Keywords
- Rare cancer, Rare subtype, Registry, Asia, Next-generation sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomic sequenceOther
Genomic sequence
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: Genomic sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of any genomic alteration in overall population
Overall incidence of any genomic alteration in overall population
Measured: 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
Measured: 1 year
Secondary outcomes (2)
Incidence of individual genomic alteration in overall population
The incidence of individual genomic alterations in overall population
Measured: 1 year
Incidence of individual genomic alteration in patients with a certain cancer type
The incidence of individual genomic alterations in patients with a certain cancer type
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start30 Nov 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rare Malignant NeoplasmStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Japan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Noboru Yamamoro, MD, PhD, Principal investigator, National Cancer Center Hospital, JapanKan Yonemori, MD, PhD, Study director, National Cancer Center Hospital, JapanKenichi Nakamura, MD, PhD, Study director, National Cancer Center Hospital, JapanYuta Maruki, MD, Study director, National Cancer Center Hospital, JapanTakuji Okusaka, MD, PhD, Principal investigator, National Cancer Center Hospital, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217407
- Sponsor's protocol ID
- NCCH2007
- Other IDs
- 20lk0201002j0001
- Acronym
- MASTERKEY ASIA
- Status last verified
- Mar 2024
- First submitted
- 24 Oct 2021
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32112563
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Registry Study of Genetic Profiling and Targeted Therapies in Patients With Rare Cancers in ASIA
- ClinicalTrials.gov ID
- NCT05217407
- Acronym / sponsor ID
- MASTERKEY ASIA / NCCH2007
- Conditions
- Rare Malignant Neoplasm
- Keywords
- Rare cancer, Rare subtype, Registry, Asia, Next-generation sequencing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Cancer Center, JapanOther government
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 1 Feb 2022 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rare cancer | – | Other: Genomic sequenceMalignancies 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 | – | Other: Genomic sequenceThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Patients with complications of cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genomic sequenceGenomic sequence | Other | Cholangiocarcinoma cohort, Rare cancer |
Primary outcome
Overall incidence of any genomic alteration in overall population
Time frame: 1 year
Overall incidence of any genomic alteration in overall population
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
2 secondary outcomes
Incidence of individual genomic alteration in overall population
Time frame: 1 year
Incidence of individual genomic alteration in patients with a certain cancer type
Time frame: 1 year
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 22 Mar 2024.
- Background: PubMed 32112563Okuma 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.
- Individual participant dataSharing planned: No
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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.
Noboru Yamamoro, MD, PhD principal investigator
National Cancer Center Hospital, Japan
Kan Yonemori, MD, PhD study director
National Cancer Center Hospital, Japan
Kenichi Nakamura, MD, PhD study director
National Cancer Center Hospital, Japan
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rare Malignant Neoplasm, run by National Cancer Center, Japan at 18 sites in 7 countries.
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 2 inclusion and 1 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 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Malaysia, Thailand, Taiwan, Vietnam, Japan and 2 more countries. 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 Chiharu Mizoguchi, MD (+81-(0)3-3542-2511, ncch2007_office@ml.res.ncc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of any genomic alteration in overall population (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT05217407, which also lists 1 linked publication.
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 22 Mar 2024.