Asian Multicenter Prospective Study of ctDNA Sequencing

Ovarian Cancer Clinical Trial

— A-TRAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05099978
• Other study ID #: NCCH1905
• Status: Recruiting
• 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
• 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).

Related Conditions & MeSH terms

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

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