Clinical trial · Observational
Asian Multicenter Prospective Study of ctDNA Sequencing
Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing: A-TRAIN
NCT05099978CI-TRIAL-00080425A-TRAINunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Clear Cell Carcinoma | — | UNRESOLVED | — |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NGS analysis of ctDNA | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NGS analysis of ctDNA
- description
- 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.
- interventionNames
- Genetic: NGS analysis of ctDNA
Primary outcomes (2)
- measure
- Percentage of patients with one or more genetic abnormalities among all examination cases
- timeFrame
- Through study completion, an average of 1 year
- description
- 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.
- measure
- Percentage of patients with each genetic abnormality among all examination cases
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.