Asian Multicenter Prospective Study of ctDNA Sequencing

Recruiting

• Conditions: Ovarian Clear Cell Carcinoma; Nasopharyngeal Carcinoma; Ovarian Cancer; Cervical Cancer; Endometrial Cancer; Triple Negative Breast Cancer
• Interventions: Genetic: NGS analysis of ctDNA

• Registration Number: NCT05099978
• Lead Sponsor: National Cancer Center, Japan

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.

Study Timeline

• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-29
• Study Start: 2021-11-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-24
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 506

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NGS analysis of ctDNA	NGS analysis of ctDNA	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with one or more genetic abnormalities among all examination cases	Through study completion, an average of 1 year	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.
Percentage of patients with each genetic abnormality among all examination cases	Through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Genomic abnormalities of ctDNA and tumor tissue will be combined to report the concordance rate	Through study completion, an average of 1 year	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.

Trial Locations

Locations (19)

Sarawak General Hospital; 🇲🇾 Kuching, Sarawak, Malaysia

University Malaya Medicine Centre; 🇲🇾 Kuala Lumpur, Selangor, Malaysia

Hospital Kuala Lumpur; 🇲🇾 Kuala Lumpur, Malaysia

Institut Kanser Negara; 🇲🇾 Putrajaya, Malaysia

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan

St. Luke's Medical Center; 🇵🇭 Manila, Philippines

National Cancer Centre of Singapore; 🇸🇬 Bukit Merah, Singapore

National University Hopital; 🇸🇬 Kent Ridge, Singapore

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand

National Taiwan University Hospital; 🇨🇳 Taipei, Zhongzheng Dist, Taiwan

Vajira Hospital; 🇹🇭 Bangkok, Thailand

Chulalongkorn University; 🇹🇭 Bangkok, Thailand

Faculty of Medicine Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand

Chiang Mai University; 🇹🇭 Chiang Mai, Thailand

Songklanagarind Hospital; 🇹🇭 Songkhla, Thailand

K Hospital; 🇻🇳 Hanoi, Vietnam

Mahidol University by Faculty of Medicine, Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Ho Chi Minh City Oncology Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of