Clinical trial NCT05099978: Asian Multicenter Prospective Study of ctDNA Sequencing
Official title: Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing: A-TRAIN
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cervical Cancer
Ovarian Clear Cell Carcinoma
Nasopharyngeal Carcinoma
Ovarian Cancer
Endometrial Cancer
Triple Negative Breast Cancer
Keywords: ctDNA
Solid tumor in Asia
Lead sponsor: National Cancer Center, Japan
Sponsor class: OTHER_GOV
First posted: 2021-10-29
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic and/or recurrent solid cancer which is targeted by each cohort in Asia.

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of patients with one or more genetic abnormalities among all examination cases
timeFrame: Through study completion, an average of 1 year
measure: Percentage of patients with each genetic abnormality among all examination cases
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Genomic abnormalities of ctDNA and tumor tissue will be combined to report the concordance rate
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medicine Centre
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara
city: Manila
country: Philippines
facility: St. Luke's Medical Center
city: Bukit Merah
country: Singapore
facility: National Cancer Centre of Singapore
city: Kent Ridge
country: Singapore
facility: National University Hopital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng Dist
city: Bangkok
country: Thailand
facility: Vajira Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn University
city: Bangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Mahidol University by Faculty of Medicine, Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Hanoi
country: Vietnam
facility: K Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Ho Chi Minh City Oncology Hospital
Study officials:
affiliation: Department of Medical Oncology, National Cancer Cancer Hospital
name: Kan Yonemori, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: