Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia

NCT ID: NCT05217407

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-30

Study Completion Date

2030-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rare Malignant Neoplasm

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Genomic sequence

Intervention Type 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.

Genomic sequence

Intervention Type OTHER

Genomic sequence

Interventions

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Genomic sequence

Genomic sequence

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Japan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noboru Yamamoro, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center Hospital, Japan

Kan Yonemori, MD, PhD

Role: STUDY_DIRECTOR

National Cancer Center Hospital, Japan

Kenichi Nakamura, MD, PhD

Role: STUDY_DIRECTOR

National Cancer Center Hospital, Japan

Yuta Maruki, MD

Role: STUDY_DIRECTOR

National Cancer Center Hospital, Japan

Takuji Okusaka, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center Hospital, Japan

Locations

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National Cancer Center Hospital, Japan

Chuo-ku, Tokyo, Japan

Site Status RECRUITING

Hospital Sultan Ismail

Johor Bahru, Johor, Malaysia

Site Status RECRUITING

Hospital Pulau Pinang

Pulau Pinang, Pulau Pinang, Malaysia

Site Status RECRUITING

Sarawak General Hospital

Kuching, Sarawak, Malaysia

Site Status RECRUITING

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status RECRUITING

University Malaya Medical Center

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Institut Kanser negara

Putrajaya, , Malaysia

Site Status RECRUITING

St. Luke's Medical Center

Manila, , Philippines

Site Status RECRUITING

National Cancer Center Korea

Seoul, , South Korea

Site Status RECRUITING

National Taiwan University Hospital

Taipei, Zhongzheng, Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Mahidol University by Faculty of Medicine, Ramathibodi Hospita

Bangkok, , Thailand

Site Status RECRUITING

Mahidol University by Faculty of Medicine, Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, , Thailand

Site Status NOT_YET_RECRUITING

Faculty of Medicine, Prince of Songkla University

Hat Yai, , Thailand

Site Status RECRUITING

Khon Kaen University by Faculty of Medicine, Srinagarind Hospital

Khon Kaen, , Thailand

Site Status RECRUITING

National Cancer Vietnam

Hanoi, , Vietnam

Site Status RECRUITING

Ho Chi Minh City Oncology Hospital

Ho Chi Minh City, , Vietnam

Site Status NOT_YET_RECRUITING

Countries

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Japan Malaysia Philippines South Korea Taiwan Thailand Vietnam

Central Contacts

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Chiharu Mizoguchi, MD

Role: CONTACT

+81-(0)3-3542-2511

Hitomi Okuma, MD, PhD

Role: CONTACT

+81-(0)3-3542-2511

Facility Contacts

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Chiharu Mizoguchi, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 32112563 (View on PubMed)

Other Identifiers

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20lk0201002j0001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCCH2007

Identifier Type: -

Identifier Source: org_study_id

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