Status:

RECRUITING

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

Lead Sponsor:

Yonsei University

Conditions:

Invasive Cancer

Healthy Volunteer

Eligibility:

All Genders

19+ years

Brief 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 thr...

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 prospe...

Eligibility Criteria

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)

Key Trial Info

Start Date :

October 13 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

4000 Patients enrolled

Trial Details

Trial ID

NCT06231953

Start Date

October 13 2022

End Date

December 1 2026

Last Update

January 30 2024

Active Locations (1)

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Yonsei Cancer Center, Yonsei Univ. College of Medicine

Seoul, South Korea

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 | DecenTrialz