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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05099978
Other study ID # NCCH1905
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source National Cancer Center, Japan
Contact Kan Yonemori, MD, PhD
Phone +81-3-3542-2511
Email NCCH1905@ml.res.ncc.go.jp
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 506
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

Genetic:
NGS analysis of ctDNA
Diagnostic Test: plasma circulating tumor DNA

Locations

Country Name City State
Japan National Cancer Center Hospital Tokyo
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Malaysia Hospital Kuala Lumpur Kuala Lumpur
Malaysia University Malaya Medicine Centre Kuala Lumpur Selangor
Malaysia Sarawak General Hospital Kuching Sarawak
Malaysia Institut Kanser Negara Putrajaya
Philippines St. Luke's Medical Center Manila
Singapore National Cancer Centre of Singapore Bukit Merah
Singapore National University Hopital Kent Ridge
Taiwan National Taiwan University Hospital Taipei Zhongzheng Dist
Thailand Chulalongkorn University Bangkok
Thailand Faculty of Medicine Ramathibodi Hospital, Mahidol University Bangkok
Thailand Mahidol University by Faculty of Medicine, Siriraj Hospital Bangkok
Thailand Phramongkutklao Hospital Bangkok
Thailand Vajira Hospital Bangkok
Thailand Chiang Mai University Chiang Mai
Thailand Songklanagarind Hospital Songkhla
Vietnam K Hospital Hanoi
Vietnam Ho Chi Minh City Oncology Hospital Ho Chi Minh City

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Center, Japan

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Malaysia,  Philippines,  Singapore,  Taiwan,  Thailand,  Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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