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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1
Yonsei Cancer Center, Yonsei Univ. College of Medicine
Seoul, South Korea