Clinical trial · Observational
Prospective Study for the Development, Validation and Confirmation of a Multi-Cancer Early Detection Platform Through Whole-Genome Sequencing Analysis of Circulating DNA in Cancer and Non-Cancer Subjects
NCT07598747CI-TRIAL-00112104recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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. This study was designed to establish a clinical and molecular database using circulating DNA from both cancer patients and non-cancer participants, advance and validate an artificial intelligence platform capable of detecting various types of cancer at an early stage, and evaluate its performance.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Healthy Participants | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cancer patients
- label
- Healthy volunteers
Primary outcomes (1)
- measure
- To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test.
- timeFrame
- Assessed up to 36 months
- description
- Sensitivity, specificity, positive predictive value, and negative predictive value of the MCED test will be calculated to evaluate its diagnostic performance for cancer detection. Sensitivity is defined as the proportion of participants with cancer who test positive on the MCED assay, while specificity is defined as the proportion of participants without cancer who test negative. Positive predictive value and negative predictive value will be calculated based on the proportion of true-positive and true-negative results among all positive and negative test results, respectively.
Secondary outcomes (2)
- measure
- To evaluate the accuracy of tumor of origin prediction of MCED test.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults aged 19 years or older 2. Individuals who understand the study and voluntarily provide informed consent. 3. (only for cancer participants) Participants with newly diagnosed solid tumors (Stage I-IV, including brain tumors) or hematologic malignancies who: * Have a histologically confirmed diagnosis (including bone marrow biopsy), or * Are highly suspected of having cancer based on clinical and/or radiologic evaluation and are scheduled for surgical resection after blood collection; and * Have not yet initiated any treatment (chemotherapy, targeted therapy, hormonal therapy, immunotherapy, radiotherapy, surgical resection, etc.). 4. (only for non-cancer participants) Individuals with no prior history of cancer. 5. (only for non-cancer participants) Individuals scheduled to undergo chest and/or abdominal CT or MRI imaging. Exclusion Criteria: 1. Pregnancy (self-reported pregnancy status). 2. Individuals for whom blood collection is deemed difficult by the investigator. 3. Individuals with a history of infection with HIV, HTLV, or syphilis. 4. (only for non-cancer participants) Individuals diagnosed with another malignancy within the past 5 years (exceptions: non-melanoma skin cancer, in-situ malignancies, thyroid cancer, and cervical intraepithelial neoplasia treated with curative intent). 5. (only for non-cancer participants) Individuals with cancer of unknown primary origin. 6. (only for non-cancer participants) Individuals with synchronous or metachronous multiple primary cancers.
References
Publications (0)
Data not yet available
No reference posted for this study.