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

Recruiting

• Conditions: Rare Malignant Neoplasm
• Interventions: Other: Genomic sequence

• Registration Number: NCT05217407
• Lead Sponsor: National Cancer Center, Japan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-24
• Study Start: 2021-11-30
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-02-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Primary Completion: 2027-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cholangiocarcinoma cohort	Genomic sequence	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.
Rare cancer	Genomic sequence	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.

Primary Outcome Measures

Name	Time	Method
Overall incidence of any genomic alteration in overall population	1 year	Overall incidence of any genomic alteration in overall population
Overall incidence of any genomic alteration in patients with a certain cancer type	1 year	Overall incidence of any genomic alteration in patients with a certain cancer type

Secondary Outcome Measures

Name	Time	Method
Incidence of individual genomic alteration in overall population	1 year	The incidence of individual genomic alterations in overall population
Incidence of individual genomic alteration in patients with a certain cancer type	1 year	The incidence of individual genomic alterations in patients with a certain cancer type

Trial Locations

Locations (18)

National Cancer Center Hospital, Japan; 🇯🇵 Chuo-ku, Tokyo, Japan

Maharaj Nakorn Chiang Mai Hospital; 🇹🇭 Chiang Mai, Thailand

Institut Kanser negara; 🇲🇾 Putrajaya, Malaysia

Mahidol University by Faculty of Medicine, Ramathibodi Hospita; 🇹🇭 Bangkok, Thailand

National Cancer Vietnam; 🇻🇳 Hanoi, Vietnam

Ho Chi Minh City Oncology Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

National Cancer Center Korea; 🇰🇷 Seoul, Korea, Republic of

St. Luke's Medical Center; 🇵🇭 Manila, Philippines

Hospital Sultan Ismail; 🇲🇾 Johor Bahru, Johor, Malaysia

Hospital Pulau Pinang; 🇲🇾 Pulau Pinang, Penang, Malaysia

Hospital Kuala Lumpur; 🇲🇾 Kuala Lumpur, Malaysia

University Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia

Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat Yai, Thailand

National Taiwan University Hospital; 🇨🇳 Taipei, Zhongzheng, Taiwan

Mahidol University by Faculty of Medicine, Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Khon Kaen University by Faculty of Medicine, Srinagarind Hospital; 🇹🇭 Khon Kaen, Thailand

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Sarawak General Hospital; 🇲🇾 Kuching, Sarawak, Malaysia