Clinical trial · Observational
A Proof of Concept Study of Pan-cancer Early Detection by Liquid Biopsy
The Performance of a Pan-cancer Early Detection Model Based on Liquid Biopsy of Various-omics Biomarkers: a Proof of Concept Study
NCT04972201CI-TRIAL-00084118PROMISEcompletedClinicalTrials.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)
PROMISE is a multi-center, prospective and proof of concept study aimed to evaluate the performance of 3 prototype assays of cell-free DNA (cfDNA) mutation, cfDNA methylation and microRNA (miRNA) expression in early detection of multi-cancer. Assay(s) will be selected for further development. The study will enroll approximately 2035 participants, including participants with cancers and healthy participants.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-cancer early detection test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cancer Arm
- description
- Participants with new diagnosis of cancer, from whom blood samples will be collected.
- interventionNames
- Device: Multi-cancer early detection test
- label
- Healthy Arm
- description
- Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected.
- interventionNames
- Device: Multi-cancer early detection test
Primary outcomes (1)
- measure
- Sensitivity of early detection of cancers and Tissue of origin (TOO) accuracy of 3 assays of cfDNA mutation, cfDNA methylation and miRNA expression when specificity was 90%, 95% or 98% in healthy participants
- timeFrame
- 9 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria for Cancer Arm Participants: * Ability to provide a written informed consent * 40-75 years old * Ability to comply with study procedures * Confirmed diagnosis or suspicious cases of one of the 9 types of cancers within 42 days prior to study blood draw. * No prior anti-cancer therapy (local or systematic) prior to study blood draw Exclusion Criteria for Cancer Arm Participants: * Pregnancy or lactating women * Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 7 days prior to study blood draw * Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer * Known prior diagnosis of malignancies, other current malignant diseases or multiple primary tumors * No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or diagnosis of a benign disease or precancerous lesions by histopathological assessments, or inability to characterize whether the lesion is malignant or benign Inclusion Criteria for Healthy Arm Participants: * Ability to provide a written informed consent * 40-75 years old * No cancer-related symptoms or discomfort within 30 days prior to study blood draw * Ability to comply with study procedures * No clinically significant finding by laboratory tests and radiology examinations Exclusion Criteria for Healthy Arm Participants: * Pregnancy or lactating women * Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 7 days prior to study blood draw * Clinically significant or uncontrolled comorbidities * Prior or ongoing treatment of cancer within 3 years prior to study blood draw
References
Publications (0)
Data not yet available
No reference posted for this study.