Clinical trial · Observational
PRediction Of Five Usual Tumors Using Blood Test for Risk Assessment and Early Detection
Peripheral Blood cfDNA Methylation, Fragmentation, and Proteomics for Multiple Cancers Early Detection: a Multicenter, Prospective, Observational, Case-control Study
- 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)
Liquid biopsy technology based on cell-free nucleic acids and protein characteristics has unique advantages and significant application prospects in cancer early detection. The purpose of this study is to collect peripheral blood samples from participants with new diagnosis of cancer and from participants who do not have a diagnosis of cancer in order to develop machine learning models for discovering cancer from non-cancer.
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 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-cancer early detection test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cancer arm
- interventionNames
- Device: Multi-cancer early detection test
- label
- Non-cancer arm
- interventionNames
- Device: Multi-cancer early detection test
Primary outcomes (2)
- measure
- Sensitivity of predefined five types of cancers and specificity of non-cancers and in different subgroup of cfDNA methylation-based model at 95% confidence interval.
- timeFrame
- 12 months
- measure
- Tissue of origin (TOO) accuracy of five types of cancers of cfDNA methylation-based model at 95% confidence interval.
- timeFrame
- 12 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria for Cancer Arm Participants: * 40-75 years old * Ability to provide a written informed consent * Confirmed cancer diagnosis within 30 days after study blood draw, based upon assessment of a pathological specimen * Have not received any systemic or local antitumor therapy, including but not limited to surgical resection, radiotherapy, hormone therapy, targeted therapy, immunotherapy, interventional therapy, etc. Exclusion Criteria for Cancer Arm Participants: * Pregnancy or lactating women * Known prior or current diagnosis of other types of malignancies comorbidities * Acute exacerbation of inflammatory condition or severe infection requiring therapy in hospital within 14 days prior to blood draw * Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 30 days prior to study blood draw * Poor health status or unfit to tolerate blood draw Inclusion Criteria for Non-Cancer Arm Participants: * 40-75 years old * Ability to provide a written informed consent * With clinically and/or pathologically diagnosed benign disease as defined by the protocol or self-reported no history of tumor and no signs of tumor as determined clinically Exclusion Criteria for Non-Cancer Arm Participants: * Pregnancy or lactating women * Any tumor history of benign or malignancies * Acute exacerbation of inflammatory condition or severe infection requiring therapy in hospital within 14 days prior to blood draw * Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 30 days prior to study blood draw * Poor health status or unfit to tolerate blood draw
References
Publications (0)
Data not yet available