Clinical trial NCT05217407: Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia
Official title: A Prospective Clinical Registry Study of Genetic Profiling and Targeted Therapies in Patients With Rare Cancers in ASIA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rare Malignant Neoplasm
Keywords: Rare cancer
Rare subtype
Registry
Asia
Next-generation sequencing
Lead sponsor: National Cancer Center, Japan
Sponsor class: OTHER_GOV
First posted: 2022-02-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall incidence of any genomic alteration in overall population
timeFrame: 1 year
measure: Overall incidence of any genomic alteration in patients with a certain cancer type
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of individual genomic alteration in overall population
timeFrame: 1 year
measure: Incidence of individual genomic alteration in patients with a certain cancer type
timeFrame: 1 year
Other outcomes:
measure: Biomarker positive proportion in overall population
timeFrame: 1 year
measure: Biomarker positive proportion in patients with a certain cancer type
timeFrame: 1 year
measure: Number of somatic variants within exons in overall population
timeFrame: 1 year
measure: Number of somatic variants within exons in patients with a certain cancer type
timeFrame: 1 year
measure: Response rate in patients treated with biomarker/genomic alteration-based therapy
timeFrame: 1 year
measure: Response rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy
timeFrame: 1 year
measure: Response rate in patients treated with immune checkpoint inhibitors
timeFrame: 1 year
measure: Disease control rate in patients treated with biomarker/genomic alteration-based therapy
timeFrame: 1 year
measure: Disease control rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy
timeFrame: 1 year
measure: Disease control rate in patients treated with immune checkpoint inhibitors
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 1 year
measure: Proportion of patients receiving no treatment with observation-only in real-world clinical practice
timeFrame: 1 year
Locations:
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital, Japan
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: National Cancer Center Korea
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
state: Johor
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
state: Penang
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
city: Putrajaya
country: Malaysia
facility: Institut Kanser negara
city: Manila
country: Philippines
facility: St. Luke's Medical Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok
country: Thailand
facility: Mahidol University by Faculty of Medicine, Ramathibodi Hospita
city: Bangkok
country: Thailand
facility: Mahidol University by Faculty of Medicine, Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Hat Yai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
city: Khon Kaen
country: Thailand
facility: Khon Kaen University by Faculty of Medicine, Srinagarind Hospital
city: Hanoi
country: Vietnam
facility: National Cancer Vietnam
city: Ho Chi Minh City
country: Vietnam
facility: Ho Chi Minh City Oncology Hospital
Study officials:
affiliation: National Cancer Center Hospital, Japan
name: Noboru Yamamoro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Center Hospital, Japan
name: Kan Yonemori, MD, PhD
role: STUDY_DIRECTOR
affiliation: National Cancer Center Hospital, Japan
name: Kenichi Nakamura, MD, PhD
role: STUDY_DIRECTOR
affiliation: National Cancer Center Hospital, Japan
name: Yuta Maruki, MD
role: STUDY_DIRECTOR
affiliation: National Cancer Center Hospital, Japan
name: Takuji Okusaka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.