Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Volunteer | — | UNRESOLVED | — |
| Invasive Cancer | Invasive Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cancer patients
- description
- Patients who have diagnosed as invasive cancers
- label
- Healthy volunteers
- description
- Subjects who have done cancer screening tests
Primary outcomes (2)
- measure
- Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value
- timeFrame
- 36 months
- measure
- Accuracy of prediction for the origin of cancer, assessed by concordance rate
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available