Table 3.
Liquid biopsy in pancreatic cancer ongoing clinical trials.
| Trial | Trial Design | Trial Purpose | Study Population | n | Primary Endpoint | Technique | Ref. |
|---|---|---|---|---|---|---|---|
| DYNAMIC-Pancreas: ctDNA Analysis Informing Adjuvant Chemotherapy in Early Stage PDAC: A Multicenter Randomized Study | Phase II/III | Prognostic | PDAC locally advance treated with neoadjuvant chemotherapy and surgery | 408 | DFS | ctDNA | ACTRN12618 000335291 |
| Mutation of KRAS, CDKN2A, SMAD4 and TP53 in PDAC | Role of Liquid Biopsy in Preoperative Diagnosis | Diagnostic | Non metastatic PDAC without any systemic metastatic spread at preoperative imaging | 50 | 1-Presence of venous and/or arterial invasion 2-Early recurrence [<12 months from resection], local or systemic recurrence after resection |
KRAS, CDKN2A, SMAD4 and TP53 mutation on circulating cfDNA | NCT03524677 |
| Prognostic Role of ctDNA in Resectable PDAC (PROJECTION) | Comparison of DFS of patients with preoperative presence of ctDNA (Group A) and absence of ctDNA (Group B) | Diagnostic Prognostic |
Resectable PDAC | 200 | To determine the stage, the remission or the progression of PDAC | Collected prior of surgery and within 14 days before start of adjuvant chemotherapy. | NCT04246203 |
| Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients with PDAC and Their Diagnostic Potential | Case control | Diagnostic | Case: Cases Subjects affected by PDAC Control: Healthy Subject enrolled following colon cancer screening via colonoscopy |
850 | DFS | Detection and quantification of EMT-transcription factor mRNA levels in blood | NCT04323917 |
| Verification of Predictive Biomarkers for PDAC Treatment Using Multicenter Liquid Biopsy | Observational | Diagnostic | Subjects affected by PDAC | 662 | Clinical applicability | 1-Quantification and monitoring of KRAS mutations Using ddPCR in ctDNA 2-Discovery of biomarkers through ctDNA panel |
NCT04241367 |
| Circulating Extracellular Exosomal Small RNA as Potential Biomarker for Human PDAC | Cohort-prospective | Diagnostic Early-detection |
PDAC and other pancreatic lesions | 102 | Sensitivity and specificity of exo-sRNA analysis | exo-sRNA | NCT04636788 |
| Diagnostic Accuracy of CTCs and Onco-exosome Quantification in the Diagnosis of PDAC-PANC-CTC (PANC-CTC) | Cohort-prospective | Diagnostic | PDAC | 52 | Sensitivity and diagnostic application of CTC detection | CTC | NCT03032913 |
| PRIMUS002: Looking at 2 Neo-adjuvant Treatment Regimens for Resectable and Borderline Resectable PDAC | Phase II non-randomized | Prognostic | -FOLFOX-A (FOLFOX + Nab-paclitaxel) -AG: Nabpaclitaxel-Gemcitabie |
278 | Time to progression | ctDNA | NCT04176952 |
| Tumor Markers, Liquid Biopsies, and Patient Reported Outcomes in Metastatic Colorectal, Pancreas, Biliary, and Esophagogastric Cancers | Observational multicohort | Prognostic | Gastrointestinal Cancer | 600 | RECIST response | CEA, CA19.9 and ctDNA | NCT04776837 |
| PLATON-Platform for Analyzing Targetable Tumor Mutations (Pilot-study) | Observational multicohort | Diagnostic | Gastrointestinal Cancer | 200 | Relative frequency of targetable mutations | FoundationOne®CDx and FoundationOne®Liquid | NCT04484636 |
| ctDNA in Pancreatic Cancer | Prospective observational | Diagnostic | Resectable pancreatic cancer | 100 | Analysis of Factors Related to PDAC Recurrence Using ctDNA | ctDNA | NCT02934984 |
| A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma | Prospective observational | Diagnostic Early-detection |
PDAC and benign pancreatic disease | 750 | Sensitivity for early diagnosis | Proteins and proteases, functional DNA repair assays, exosomes, stromal elements, cRNAs and ctDNA | NCT 03334708 |
| Blood Markers of Early Pancreas Cancer | Prospective observational | Early-detection | New onset diabetes, high risk pre-diabetes Pancreatic cystic neoplasms and pancreatitis Familial risk | 1250 | Sensitivity for early diagnosis | cfDNA | NCT03568630 |
| Nalirinox Neo-pancreas RAS Mut ctDNA Study | Phase II | Prognostic | Patients with Resectable PDAC Treated with Neoadjuvant NALIRINOX | 20 | Monitoring response | KRAS ctDNA | NCT04010552 |
ctDNA: circulating tumor DNA; cfDNA: cell free DNA; cRNAs: circular RNAs; PDAC: pancreatic ductal adenocarcinoma; DFS: disease-free survival; CTCs: circulating tumor cells; EMT: epithelial-mesenchymal transition.