Asian Multicenter Prospective Study of ctDNA Sequencing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cervical Cancer, Ovarian Clear Cell Carcinoma, Nasopharyngeal Carcinoma, Ovarian Cancer, Endometrial Cancer, Triple Negative Breast Cancer

Intervention / Treatment
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* Genetic: NGS analysis of ctDNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 years or older at registration. Diagnosis of cancer which is targeted by each cohort. Metastatic and/or recurrent disease. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NGS analysis of ctDNA<br>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<br>* Diagnostic Test: plasma circulating tumor DNA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ctDNA, Solid tumor in Asia