Clinical trial · Observational
Multi-omics Model for Pancreatic Cancer Screening Using cfDNA
Development and Validation of Multi-omics Model for Screening of Pancreatic Cancer Using cfDNA
NCT06456281CI-TRIAL-00078438unknownClinicalTrials.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 case-control study, aiming at developing a cell free DNA (cfDNA) multi-omics precise diagnostic model for screening of pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A noninvasive cfDNA multi-omics assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cancer arm
- description
- Participants with new diagnosis of pancreatic cancer.
- interventionNames
- Diagnostic Test: A noninvasive cfDNA multi-omics assay
- label
- Precancerous lesions arm
- description
- Participants with precancerous lesions.
- interventionNames
- Diagnostic Test: A noninvasive cfDNA multi-omics assay
- label
- Healthy individuals arm
- description
- Healthy individuals without findings of clinical significance during routine health checkups.
- interventionNames
- Diagnostic Test: A noninvasive cfDNA multi-omics assay
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Cancer Arm Inclusion Criteria: * 18-75 years old * Clinically and/or pathologically diagnosed pancreatic cancer * No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc. * Able to provide a written informed consent and willing to comply with all part of the protocol procedures * Physical status score ECOG 0-1 Exclusion Criteria: * Pregnancy or lactating women * Known prior or current diagnosis of other types of malignancies comorbidities * Severe acute infection or febrile illness within 14 days prior to blood draw * Recipients of organ transplant or prior bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 30 days prior to study blood draw * Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide * Other conditions that the investigators considered are not suitable for the enrollment Precancerous Lesions Arm Inclusion Criteria: * 18-75 years old * Diagnosed with pancreatic intraepithelial tumor pancreatic intraepithelial lesions (PanINs), Intraductal papillary mucinous neoplasms (IPMN) or mucinous cystic neoplasms (MCN) by radiographical assess * No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc. * Able to provide a written informed consent and willing to comply with all part of the protocol procedures Exclusion Criteria: * Pregnancy or lactating women * Known prior or current diagnosis of other types of malignancies comorbidities * Severe acute infection or febrile illness within 14 days prior to blood draw * Recipients of organ transplant or prior bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 30 days prior to study blood draw * Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide * Other conditions that the investigators considered are not suitable for the enrollment Healthy Individuals Arm Inclusion Criteria: * 18-75 years old * Clinically and/or pathologically diagnosed pancreatic non-malignant disease (pancreatic intraepithelial neoplasia, pancreatic cyst and chronic pancreatitis) * No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc. * Able to provide a written informed consent and willing to comply with all part of the protocol procedures Exclusion Criteria: * Pregnancy or lactating women * Known prior or current diagnosis of other types of malignancies comorbidities * Severe acute infection or febrile illness within 14 days prior to blood draw * Recipients of organ transplant or prior bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 30 days prior to study blood draw * Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide * Other conditions that the investigators considered are not suitable for the enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.