Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 20lk0201002j0001 | Other Grant/Funding Number | AMED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rare cancer | 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. |
| |
| Cholangiocarcinoma cohort | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genomic sequence | Other | Genomic sequence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall incidence of any genomic alteration in overall population | Overall incidence of any genomic alteration in overall population | 1 year |
| Overall incidence of any genomic alteration in patients with a certain cancer type | Overall incidence of any genomic alteration in patients with a certain cancer type | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of individual genomic alteration in overall population | The incidence of individual genomic alterations in overall population | 1 year |
| Incidence of individual genomic alteration in patients with a certain cancer type |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker positive proportion in overall population | The proportion of patients positive for certain biomarkers in overall population | 1 year |
| Biomarker positive proportion in patients with a certain cancer type |
Inclusion Criteria:
Exclusion Criteria:
1. Patients with complications of cognitive impairment.
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiharu Mizoguchi, MD | Contact | +81-(0)3-3542-2511 | ncch2007_office@ml.res.ncc.go.jp | |
| Hitomi Okuma, MD, PhD | Contact | +81-(0)3-3542-2511 | ncch2007_office@ml.res.ncc.go.jp |
| Name | Affiliation | Role |
|---|---|---|
| Noboru Yamamoro, MD, PhD | National Cancer Center Hospital, Japan | Principal Investigator |
| Kan Yonemori, MD, PhD | National Cancer Center Hospital, Japan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital, Japan | Recruiting | Chuo-ku | Tokyo | 104-0045 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32112563 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
whole blood, tissue
The incidence of individual genomic alterations in patients with a certain cancer type
| 1 year |
The proportion of patients positive for certain biomarkers in patients with a certain cancer type
| 1 year |
| Number of somatic variants within exons in overall population | The number of somatic variants and proportion of variants in overall population | 1 year |
| Number of somatic variants within exons in patients with a certain cancer type | The number of somatic variants and proportion of variants in patients with a certain cancer type | 1 year |
| Response rate in patients treated with biomarker/genomic alteration-based therapy | Response rate in patients treated with biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type. | 1 year |
| Response rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy | Response rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type. | 1 year |
| Response rate in patients treated with immune checkpoint inhibitors | Response rate in patients treated with immune checkpoint inhibitors in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type. | 1 year |
| Disease control rate in patients treated with biomarker/genomic alteration-based therapy | Disease control rate in patients treated with biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type. | 1 year |
| Disease control rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy | Disease control rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type. | 1 year |
| Disease control rate in patients treated with immune checkpoint inhibitors | Disease control rate in patients treated with immune checkpoint inhibitors in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type. | 1 year |
| Overall survival | Overall survival in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type. | 1 year |
| Progression-free survival | Progression-free survival in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type. | 1 year |
| Proportion of patients receiving no treatment with observation-only in real-world clinical practice | Proportion of patients receiving no treatment with observation-only in real-world clinical practice in overall population & in patients with a certain cancer type. Proportion of patients receiving no treatment or observation with best supportive care in real-world clinical practice in overall population & in patients with a certain cancer type. | 1 year |
| Kenichi Nakamura, MD, PhD |
| National Cancer Center Hospital, Japan |
| Study Director |
| Yuta Maruki, MD | National Cancer Center Hospital, Japan | Study Director |
| Takuji Okusaka, MD, PhD | National Cancer Center Hospital, Japan | Principal Investigator |
| Hospital Sultan Ismail | Recruiting | Johor Bahru | Johor | Malaysia |
| Hospital Pulau Pinang | Recruiting | Pulau Pinang | Pulau Pinang | Malaysia |
| Sarawak General Hospital | Recruiting | Kuching | Sarawak | 93586 | Malaysia |
| Hospital Kuala Lumpur | Recruiting | Kuala Lumpur | 50586 | Malaysia |
| University Malaya Medical Center | Recruiting | Kuala Lumpur | Malaysia |
| Institut Kanser negara | Recruiting | Putrajaya | 62250 | Malaysia |
| St. Luke's Medical Center | Recruiting | Manila | 1102 | Philippines |
| National Cancer Center Korea | Recruiting | Seoul | South Korea |
| National Taiwan University Hospital | Recruiting | Taipei | Zhongzheng | 100225 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | Taiwan |
| Mahidol University by Faculty of Medicine, Ramathibodi Hospita | Recruiting | Bangkok | Thailand |
| Mahidol University by Faculty of Medicine, Siriraj Hospital | Recruiting | Bangkok | Thailand |
| Maharaj Nakorn Chiang Mai Hospital | Not yet recruiting | Chiang Mai | Thailand |
| Faculty of Medicine, Prince of Songkla University | Recruiting | Hat Yai | Thailand |
| Khon Kaen University by Faculty of Medicine, Srinagarind Hospital | Recruiting | Khon Kaen | Thailand |
| National Cancer Vietnam | Recruiting | Hanoi | Vietnam |
| Ho Chi Minh City Oncology Hospital | Not yet recruiting | Ho Chi Minh City | Vietnam |