Asian Multicenter Prospective Study of ctDNA Sequencing (A-TRAIN)

September 2, 2024 updated by: National Cancer Center, Japan

Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing: A-TRAIN

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

506

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
      • Putrajaya, Malaysia, 62250
        • Institut Kanser Negara
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak General Hospital
    • Selangor
      • Kuala Lumpur, Selangor, Malaysia, 59100
        • University Malaya Medicine Centre
  • Philippines
      • Manila, Philippines, 1102
        • St. Luke's Medical Center
  • Singapore
      • Bukit Merah, Singapore, 168582
        • National Cancer Centre of Singapore
      • Kent Ridge, Singapore, 119228
        • National University Hopital
  • Taiwan
    • Zhongzheng Dist
      • Taipei, Zhongzheng Dist, Taiwan, 100225
        • National Taiwan University Hospital
  • Thailand
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Bangkok, Thailand, 10330
        • Chulalongkorn University
      • Bangkok, Thailand, 10400
        • Faculty of Medicine Ramathibodi Hospital, Mahidol University
      • Bangkok, Thailand, 10300
        • Vajira Hospital
      • Bangkok, Thailand, 10700
        • Mahidol University by Faculty of Medicine, Siriraj Hospital
      • Chiang Mai, Thailand, 50200
        • Chiang Mai University
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital
  • Vietnam
      • Hanoi, Vietnam
        • K Hospital
      • Ho Chi Minh City, Vietnam
        • Ho Chi Minh City Oncology Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with metastatic and/or recurrent solid cancer which is targeted by each cohort in Asia.

Description

Inclusion Criteria:

  1. Age of 18 years or older at registration.
  2. Diagnosis of cancer which is targeted by each cohort.
  3. Metastatic and/or recurrent disease.

Exclusion Criteria:

  1. 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.
  2. 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).
  3. Ongoing radiation therapy. (There are no limits on the time from completion of radiation therapy to registration).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Genetic: NGS analysis of ctDNA
Diagnostic Test: plasma circulating tumor DNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with one or more genetic abnormalities among all examination cases
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomic abnormalities of ctDNA and tumor tissue will be combined to report the concordance rate
Time Frame: Through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Japan

Investigators

  • Principal Investigator: Kan Yonemori, MD, PhD, Department of Medical Oncology, National Cancer Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

September 2, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCH1905

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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