Asian Multicenter Prospective Study of ctDNA Sequencing

National Cancer Center, Japan506 enrolled

Overview

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.

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

506

Conditions

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

Interventions

NGS analysis of ctDNAGENETIC

Diagnostic Test: plasma circulating tumor DNA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (19)

National Cancer Center Hospital

Tokyo, Japan

Sarawak General Hospital

Kuching, Sarawak, Malaysia

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

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.

Time frame: Through study completion, an average of 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.