Asian Multicenter Prospective Study of ctDNA Sequencing
A-TRAIN
1 other identifier
observational
506
8 countries
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2021
CompletedFirst Posted
Study publicly available on registry
October 29, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedSeptember 4, 2024
October 1, 2023
3.2 years
September 21, 2021
September 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Genomic abnormalities of ctDNA and tumor tissue will be combined to report the concordance rate
Through study completion, an average of 1 year
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients with metastatic and/or recurrent solid cancer which is targeted by each cohort in Asia.
You may qualify if:
- Age of 18 years or older at registration.
- Diagnosis of cancer which is targeted by each cohort.
- Metastatic and/or recurrent disease.
You may not qualify if:
- Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the esophagus, stomach, colon, or cervix.
- Ongoing chemotherapy. (Chemotherapy-naïve patients or awaiting initiation of the next line of chemotherapy are eligible. There is no limit on the number of prior chemotherapies or on the time from completion of chemotherapy to registration).
- Ongoing radiation therapy. (There are no limits on the time from completion of radiation therapy to registration).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
National Cancer Center Hospital
Tokyo, 104-0045, Japan
Sarawak General Hospital
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
Biospecimen
Peripheral blood sample and unstained 5-micron formalin-fixed paraffin-embedded (FFPE) tumor tissue section
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kan Yonemori, MD, PhD
Department of Medical Oncology, National Cancer Cancer Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2021
First Posted
October 29, 2021
Study Start
November 1, 2021
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
September 4, 2024
Record last verified: 2023-10