Clinical trial · Observational
Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT
Pan-cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Multi-center, Prospective Observational Study
NCT04822792CI-TRIAL-00052065PRESCIENTunknownClinicalTrials.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)
PRESCIENT is a multi-center, prospective observational study aimed to detect cancers early by combined assays for serum protein markers and cell-free DNA (cfDNA) methylation markers. Blood RNA markers will also be evaluated. The study will enroll approximately 11879 participants, including participants with malignancies or benign diseases, 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 (3)
- 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
- Benign Diseases Arm
- description
- Participants with benign diseases corresponding to the tumor types in the Cancer Arm, 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 disease, from whom blood samples will be collected
- interventionNames
- Device: Multi-cancer early detection test
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria for All the Participants: * Ability to provide a written informed consent * 40-75 years old Exclusion Criteria for All the Participants: * Inability to comply with study procedures * 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 Inclusion Criteria for Cancer Arm Participants: * Confirmed diagnosis or suspicious cases of one of the 22 types of malignancies within 42 days prior to study blood draw * No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw Exclusion Criteria for Cancer Arm Participants: * 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 by histopathological assessments, or inability to characterize whether the lesion is malignant or benign * Non-small-cell lung cancer patients with ground-class nodularity by radiological examination Inclusion Criteria for Benign Diseases Arm Participants: * Confirmed diagnosis of benign diseases corresponding to the tumor types in the Cancer Arm by histopathological or radiological assessments within 90 days prior to study blood draw * No prior treatment of benign diseases prior to study blood draw Exclusion Criteria for Benign Diseases Arm Participants: * History of malignancies * Current malignancies or precancerous lesions * No confirmed diagnosis of a benign disease by radiological, endoscopic or histopathological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign Inclusion Criteria for Non-tumor (Healthy) Arm Participants: * No cancer-related symptoms or discomfort within 30 days prior to study blood draw * No clinically significant finding by LDCT or ultrasound * No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or Thinprep cytologic test (TCT) detection for female participants * No active hepatitis B or hepatitis C infection Exclusion Criteria for Non-tumor (Healthy) Arm Participants: * Prior or ongoing treatment of cancer within 3 years prior to study blood draw * Clinically significant or uncontrolled comorbidities
References
Publications (0)
Data not yet available
No reference posted for this study.