Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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
National Cancer Center Korea
🇰🇷Seoul, Korea, Republic of
Hospital Sultan Ismail
🇲🇾Johor Bahru, Johor, Malaysia
Hospital Pulau Pinang
🇲🇾Pulau Pinang, Penang, Malaysia
Sarawak General Hospital
🇲🇾Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
University Malaya Medical Center
🇲🇾Kuala Lumpur, Malaysia
Institut Kanser negara
🇲🇾Putrajaya, Malaysia
St. Luke's Medical Center
🇵🇭Manila, Philippines
National Taiwan University Hospital
🇨🇳Taipei, Zhongzheng, Taiwan
Scroll for more (8 remaining)National Cancer Center Hospital, Japan🇯🇵Chuo-ku, Tokyo, JapanChiharu Mizoguchi, MDContact