Clinical trial · Observational
Assessment of Early Pancreatic Cancer Prognosis by Minimal Residual Disease Using Multi-omics Approach
Explorations of Cell-free DNA Multi-omics Technology in Detection of Minimal Residual Disease and Disease Prognosis After Surgery in Early Pancreatic Ductal Adenocarcinoma: A Single-center, Prospective, Observational Case Study
NCT06151691CI-TRIAL-00071845unknownClinicalTrials.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 trial aims to develop a minimal residual disease (MRD) detection model for predicting recurrence of patients with stage I-II pancreatic ductal adenocarcinoma after surgery and adjuvant therapy, based on cfDNA fragmentation and methylation signal.
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 Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Case-Cancer arm
- description
- Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test
- interventionNames
- Other: Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test
Primary outcomes (1)
- measure
- 1.5-year disease-free survival
- timeFrame
- 18 months
- description
- 1.5-year disease-free survival of patients with pancreatic ductal adenocarcinoma receiving post-operative adjuvant chemotherapy.
Secondary outcomes (4)
- measure
- Sensitivity of the multi-omics prognostic model
- timeFrame
- 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria: 1. Patients with clinically and/or pathologically diagnosis of stage I/II pancreatic ductal adenocarcinoma; 2. Aged ≥ 40 years and \< 75 years, both sexes; 3. Patients receive radical resection with curative intent, followed by adjuvant therapy; 4. Tumour size not less than 1 cm \* 1 cm \* 1 cm and be able to provide surgical tissue samples for molecular testing after pathological evaluation; 5. Eastern Cooperative Oncology Group (ECOG) score of 0-2; 6. Negative margins (R0 or R1) by naked eye or no recurrence/metastasis detected on imaging after surgery or before adjuvant therapy, and CA 19-9\<37 U/ml; 7. Patients understand and voluntarily sign the informed consent form and follow the sampling, assessment and visit requirements of this study. Exclusion criteria: 1. Pregnant and lactating (by self-report); 2. Any tumor history of malignancies; 3. Positive cutting margins (R2); 4. Received neoadjuvant therapy before surgery; 5. Not be able to receive radical surgery; 6. Organ transplantation history; 7. Organ dysfunction (moderate or severe renal impairment with absolute centrocyte count \< 1.0 x 10\^9/L, platelet count \< 75 x 10\^9/L, haemoglobin \< 80 g/L, AST/ALT \> 2.5 times upper limit of normal); 8. Other conditions deemed unsuitable for enrollment by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.