Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia (MASTERKEY ASIA)

National Cancer Center, Japan

Status: Enrolling

Conditions: Rare Malignant Neoplasm

Treatments: Other: Genomic sequence

Study type: Observational

Funder types: Other

Identifiers

NCT05217407

20lk0201002j0001 (Other Grant/Funding Number)

NCCH2007

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

Rare cancer

Description:

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.

Treatment:

Other: Genomic sequence

Cholangiocarcinoma cohort

Description:

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.

Treatment:

Other: Genomic sequence