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Recruiting NCT05217407

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

Observational Rare Malignant Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Genomic sequence.
Who it may be relevant to
Registry conditions: Rare Malignant Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan, Malaysia, Philippines, South Korea, Taiwan +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Clinical Registry Study of Genetic Profiling and Targeted Therapies in Patients With Rare Cancers in ASIA

Overview

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.

Interventions

  • Other Genomic sequence
    Genomic sequence

Primary outcome measures

  • Overall incidence of any genomic alteration in overall population [Time frame: 1 year]
  • Overall incidence of any genomic alteration in patients with a certain cancer type [Time frame: 1 year]
Secondary outcome measures (2)
  • Incidence of individual genomic alteration in overall population [Time frame: 1 year]
  • Incidence of individual genomic alteration in patients with a certain cancer type [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

1\. Patients with complications of cognitive impairment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Malaysia · 6 centers
  • Hospital Sultan Ismail — Johor Bahru
  • Hospital Pulau Pinang — Pulau Pinang
  • Sarawak General Hospital — Kuching
  • Hospital Kuala Lumpur — Kuala Lumpur
  • University Malaya Medical Center — Kuala Lumpur
  • Institut Kanser negara — Putrajaya
Thailand · 5 centers
  • Mahidol University by Faculty of Medicine, Ramathibodi Hospita — Bangkok
  • Mahidol University by Faculty of Medicine, Siriraj Hospital — Bangkok
  • Maharaj Nakorn Chiang Mai Hospital — Chiang Mai
  • Faculty of Medicine, Prince of Songkla University — Hat Yai
  • Khon Kaen University by Faculty of Medicine, Srinagarind Hospital — Khon Kaen
Taiwan · 2 centers
  • National Taiwan University Hospital — Taipei
  • Taipei Veterans General Hospital — Taipei
Vietnam · 2 centers
  • National Cancer Vietnam — Hanoi
  • Ho Chi Minh City Oncology Hospital — Ho Chi Minh City
Japan · 1 center
  • National Cancer Center Hospital, Japan — Chuo-ku
Philippines · 1 center
  • St. Luke's Medical Center — Manila
South Korea · 1 center
  • National Cancer Center Korea — Seoul

Publications

  • Okuma HS, Yonemori K, Narita SN, Sukigara T, Hirakawa A, Shimizu T, Shibata T, Kawai A, Yamamoto N, Nakamura K, Nishida T, Fujiwara Y. MASTER KEY Project: Powering Clinical Development for Rare Cancers Through a Platform Trial. Clin Pharmacol Ther. 2020 Sep;108(3):596-605. doi: 10.1002/cpt.1817. Epub 2020 Apr 7. PMID 32112563

Identifiers

NCT: NCT05217407 · NCCH2007 · 20lk0201002j0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗