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

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ClinicalTrials.gov Identifier: NCT05099978
Recruitment Status : Recruiting
First Posted : October 29, 2021
Last Update Posted : October 24, 2023
Sponsor:
Information provided by (Responsible Party):
National Cancer Center, Japan

Tracking Information
First Submitted Date September 21, 2021
First Posted Date October 29, 2021
Last Update Posted Date October 24, 2023
Actual Study Start Date November 1, 2021
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 20, 2021)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 20, 2021)		 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Asian Multicenter Prospective Study of ctDNA Sequencing
Official Title Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing: A-TRAIN
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Peripheral blood sample and unstained 5-micron formalin-fixed paraffin-embedded (FFPE) tumor tissue section
Sampling Method Probability Sample
Study Population Patients with metastatic and/or recurrent solid cancer which is targeted by each cohort in Asia.
Condition
  • Cervical Cancer
  • Ovarian Clear Cell Carcinoma
  • Nasopharyngeal Carcinoma
  • Ovarian Cancer
  • Endometrial Cancer
  • Triple Negative Breast Cancer
Intervention Genetic: NGS analysis of ctDNA
Diagnostic Test: plasma circulating tumor DNA
Study Groups/Cohorts 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.

Intervention: Genetic: NGS analysis of ctDNA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 20, 2021)		 506
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kan Yonemori, MD, PhD +81-3-3542-2511 NCCH1905@ml.res.ncc.go.jp
Listed Location Countries Japan,   Korea, Republic of,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number NCT05099978
Other Study ID Numbers NCCH1905
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party National Cancer Center, Japan
Original Responsible Party Same as current
Current Study Sponsor National Cancer Center, Japan
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Kan Yonemori, MD, PhD Department of Medical Oncology, National Cancer Cancer Hospital
PRS Account National Cancer Center, Japan
Verification Date October 2023