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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06231953
Other study ID # 4-2022-0299
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 13, 2022
Est. completion date December 2026

Study information

Verified date January 2024
Source Yonsei University
Contact Joohyuk Sohn
Phone +82-2-2228-8135
Email oncosohn@yuhs.ac
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA. The study will enroll 4,000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea.


Description:

AIMA is analysing whole genome sequencing data of circulating tumor DNA, combined through machine learning technique, to develop MCED platform to detect early stage cancer. The purpose of this prospective, multi-center, observational study is to validate an MCED platform for the early detection of cancers. The investigators will collect blood samples from subjects who are diagnosed as invasive cancers before treatment or from healthy volunteers.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Aged 19 years or older - Subjects who have been diagnosed with stages 1 to 4 of solid tumor or healthy volunteers who have scheduled a cancer screening examination - Subjects who have agreed to provide clinical information and blood samples - Subjects who have agreed for the storage and secondary use of residual blood samples for research - Subjects who have understood the study and are able to provide a written informed consent Exclusion Criteria: - Subjects who are not appropriate for the study because of intellectual disabilities or severe mental disorders - Subjects with a history of HIV, HTLV, or Syphilis infection - Subjects with primary site unknown cancer or synchronous or metachronous double primary cancers - Subjects who have diagnosed with any other malignant tumor within the past 5 years (except for cured non-melanoma skin cancer, in situ cancer, or thyroid cancer)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Yonsei Cancer Center, Yonsei Univ. College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value 36 months
Primary Accuracy of prediction for the origin of cancer, assessed by concordance rate 36 months
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