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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036756

Enrollment

500

Registered

2019-05-16

Start date

2018-10-15

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 hematologic malignancies

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 0 year or older at registration. 2. Patients with a final diagnosis of hematologic malignancy from a histology, cytology, flowcytometory, cytogenetic analysis or molecular genetic analysis. 3. Patients with hematologic malignancies with no radical standard therapy (whether new or recurrent). 4. Patients who already have results from an NGS analysis or molecular diagnostic testing (e.g., immunohistochemistry, FISH, RT-PCR) conducted by either own site or an external laboratory or patients with these tests requested from 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, if the patient understands the explanation and wishes to consent but has a physical disability in signing due to nerve symptoms, a legal representative may sign on the patient's behalf to confirm consent, if the patient wishes (the patient will appoint one of the following as a legal representative: the patient's spouse, adult child, parent, adult sibling, adult grandchild, grandparent, family member of the same household or considered to be of a status equivalent to that of a close relative).

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

Measure	Time 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 Support Office

michimur@ncc.go.jp03-3542-2511

Outcome results