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

National Cancer Center, Japan

Status: Active, not recruiting

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

Treatments: Genetic: NGS analysis of ctDNA

Study type: Observational

Funder types: Other

Identifiers

NCT05099978

NCCH1905

Details and patient eligibility

About

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.

Full 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.

Enrollment: 506 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

506 participants in 1 patient group

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.

Treatment:

Genetic: NGS analysis of ctDNA