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A prospective clinical registry study of genetic profiling and targeted therapies in patients with rare cancers; MASTER KEY Protocol

A prospective clinical registry study of genetic profiling and targeted therapies in patients with rare cancers; MASTER KEY Protocol - Marker Assisted Selective ThErapy in Rare cancers: Knowledge database Establishing registrY Protocol; MASTER KEY Protocol

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000027552
Enrollment
1000
Registered
2017-05-31
Start date
2017-05-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rare cancer, cancer of unknown primary, and rare histological subtypes of common cancers

Interventions

None listed

Sponsors

National Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 0 years or older at registration. 2. Patients with histological diagnosis of rare cancer, cancer of unknown primary, or rare histological subtypes of common cancers. 3. Patients with incurable progressive (metastatic and/or unresectable) lesions (number of prior regimens will not be limited). 4. Patients who had already received next-generation sequencing (NGS) or molecular diagnostic testing (e.g., immunohistochemical staining, FISH), patients with these tests requested, or patients who have provided oral or written consent for these tests (whether conducted by either own site or an external laboratory). 5. Patients who provided a written consent to participate in the study (for patients less than 20 years of age, their legally acceptable representative must give consent). However, those who are physically unable to give a signature can have it done by someone appointed by the patient.

Exclusion criteria

Exclusion criteria: 1. Patients with complications of psychiatric disorders/symptoms that interfere daily life are considered to hamper their participation in the study.

Design outcomes

Primary

MeasureTime frame
1) Overall incidence of genetic abnormality 2) Incidence of individual genetic abnormalities 3) Biomarker-positive rate 4) Number of somatic mutations and distribution of mutation rate within exons 5) Response rate 6) Disease control rate 7) Overall survival 8) Progression-free survival

Countries

Japan

Contacts

Public ContactMasahiko Ichimura

National Cancer Center Hospital Clinical Trial Management Section, Research Management Division, Clinical Research Support Office

NCCH1612_office@ml.res.ncc.go.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026