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This study is a genetic analysis of aberrations in circulating tumor DNA (ctDNA) in patients in Asian countries. This study protocol is divided into parts describing several subanalyses that differ in terms of cancer types, analytical methods, participating countries, and participating institutions.
NGS analysis will be performed on cfDNA extracted from peripheral blood samples of target patients to determine the types and incidences of genetic abnormalities. Patient information and gene abnormality data will be integrated, and the types and incidences of gene abnormalities by cancer type will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGS analysis of ctDNA | This study consists of 6 cohorts; cervical cancer(n=100), ovarian clear cell cancer(n=50), nasopharyngeal cancer(n=96), ovarian cancer(n=100), breast cancer(n=100), endometrial cancer(n=60). In each cohort, the blood samples will be collected within 2weeks after registration. ctDNA will be extracted from blood samples and somatic gene abnormalities will be analyzed using NGS, PCR, and Sanger sequencing. In addition, the analysis of DNA methylation and RNA sequencing may be performed to obtain information related to gene expression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGS analysis of ctDNA | Genetic | Diagnostic Test: plasma circulating tumor DNA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with one or more genetic abnormalities among all examination cases | DNA may be extracted from blood or tumor tissue samples, and germline gene abnormality may be analyzed using techniques such as PCR, NGS, and Sanger sequencing. | Through study completion, an average of 1 year |
| Percentage of patients with each genetic abnormality among all examination cases | DNA may be extracted from blood or tumor tissue samples, and germline gene abnormality may be analyzed using techniques such as PCR, NGS, and Sanger sequencing. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Genomic abnormalities of ctDNA and tumor tissue will be combined to report the concordance rate | Concordance rate is defined by the sum of concordance on positives with the denominator as the total number of genes in which a genomic alteration is detected, i.e., genes in which alterations are not detected by one of assays are excluded from both the numerator and denominator. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with metastatic and/or recurrent solid cancer which is targeted by each cohort in Asia.
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| Name | Affiliation | Role |
|---|---|---|
| Kan Yonemori, MD, PhD | Department of Medical Oncology, National Cancer Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan | |||
| Sarawak General Hospital |
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Peripheral blood sample and unstained 5-micron formalin-fixed paraffin-embedded (FFPE) tumor tissue section
| Kuching |
| Sarawak |
| 93586 |
| Malaysia |
| University Malaya Medicine Centre | Kuala Lumpur | Selangor | 59100 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Institut Kanser Negara | Putrajaya | 62250 | Malaysia |
| St. Luke's Medical Center | Manila | 1102 | Philippines |
| National Cancer Centre of Singapore | Bukit Merah | 168582 | Singapore |
| National University Hopital | Kent Ridge | 119228 | Singapore |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| National Taiwan University Hospital | Taipei | Zhongzheng Dist | 100225 | Taiwan |
| Vajira Hospital | Bangkok | 10300 | Thailand |
| Chulalongkorn University | Bangkok | 10330 | Thailand |
| Faculty of Medicine Ramathibodi Hospital, Mahidol University | Bangkok | 10400 | Thailand |
| Phramongkutklao Hospital | Bangkok | 10400 | Thailand |
| Mahidol University by Faculty of Medicine, Siriraj Hospital | Bangkok | 10700 | Thailand |
| Chiang Mai University | Chiang Mai | 50200 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| K Hospital | Hanoi | Vietnam |
| Ho Chi Minh City Oncology Hospital | Ho Chi Minh City | Vietnam |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D000077274 | Nasopharyngeal Carcinoma |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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