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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer; Invasive Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Joohyuk Sohn; Phone Number: +82-2-2228-8135; Email: oncosohn@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei Cancer Center, Yonsei Univ. College of Medicine
    • Contact: Joohyuk Sohn; Phone Number: +82-2-2228-8135; Email: oncosohn@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects who have diagnosed invasive cancer or healthy volunteers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cancer patients; Patients who have diagnosed as invasive cancers
Healthy volunteers; Subjects who have done cancer screening tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value	36 months
Accuracy of prediction for the origin of cancer, assessed by concordance rate	36 months

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Joohyuk Sohn, Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: January 21, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 4-2022-0299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No