Actively Recruiting
Multi-Cancer Early Detection Platform Study Using Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers
Led by Yonsei University · Updated on 2024-01-30
4000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a Multi-Cancer Early Detection (MCED) platform using whole genome sequencing of circulating tumor DNA combined with machine learning. This prospective, multi-center observational study aims to validate this MCED platform for the early detection of invasive cancers. The study plans to enroll 4,000 subjects including cancer patients and healthy volunteers across up to 10 clinical institutions in South Korea. Participants include those diagnosed with invasive solid tumors at various stages before treatment and healthy volunteers scheduled for cancer screening tests. Blood samples and clinical information will be collected from all participants. The study does not involve experimental treatments but focuses on analyzing circulating DNA to detect cancer early. During the study, participants will provide blood samples and clinical data for analysis. Researchers will assess the diagnostic accuracy of the MCED platform by measuring the positive and negative predictive values for invasive cancer diagnosis and the concordance rate for predicting the cancer origin over a 36-month period. Participants will be monitored for up to three years to evaluate these outcomes.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 19 years or older
- Diagnosed with stages 1 to 4 of solid tumor or healthy volunteer scheduled for cancer screening
- Agreed to provide clinical information and blood samples
- Agreed for storage and secondary use of residual blood samples for research
- Able to understand the study and provide written informed consent
You will not qualify if you...
- Intellectual disabilities or severe mental disorders making participation inappropriate
- History of HIV, HTLV, or Syphilis infection
- Primary site unknown cancer or multiple primary cancers occurring simultaneously or sequentially
- Diagnosed with any other malignant tumor within the past 5 years except cured non-melanoma skin cancer, in situ cancer, or thyroid cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At enrollment
Participants provide blood samples for whole genome sequencing analysis to detect early-stage cancers.
1 visit (in-person)
Duration - Up to 36 months
Participants are observed over time to validate the multi-cancer early detection platform through clinical follow-up and outcome assessments.
Periodic follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Yonsei Cancer Center, Yonsei Univ. College of Medicine
Seoul, South Korea
Actively Recruiting
Research Team
J
Joohyuk Sohn
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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