A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231953
• Other study ID #: 4-2022-0299
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Healthy Volunteer
• Invasive Cancer

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