Pancreatic Ductal Adenocarcinoma Clinical Trial
Official title:
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
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.
Status | Not yet recruiting |
Enrollment | 51 |
Est. completion date | November 30, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University | Shanghai Weihe Medical Laboratory Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1.5-year disease-free survival | 1.5-year disease-free survival of patients with pancreatic ductal adenocarcinoma receiving post-operative adjuvant chemotherapy. | 18 months | |
Secondary | Sensitivity of the multi-omics prognostic model | Sensitivity of the multi-omics prognostic model for pancreatic ductal adenocarcinoma based on cfDNA methylation, fragmentation group, and CNV features in patients with recurrence at 95% confidence interval | 18 months | |
Secondary | Specificity of the multi-omics prognostic model | Specificity of the multi-omics prognostic model for pancreatic ductal adenocarcinoma patients without recurrence at 95% confidence intervals. | 18 months | |
Secondary | Area under the receiver operating characteristic curve (AUROC) of the multi-omics prognostic model | Area under the receiver operating characteristic curve (AUROC) of the multi-omics prognostic model for predicting patient recurrence of pancreatic ductal adenocarcinoma at 95% confidence intervals. | 18 months | |
Secondary | Sensitivity of the multi-omics prognostic model in different subgroups | Sensitivity of the multi-omics prognostic model for predicting pancreatic ductal adenocarcinoma recurrence in different subgroups (age, underlying medical history, tumour differentiation, tumour diameter, etc.) at 95% confidence intervals. | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05209074 -
Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
|
Phase 1 | |
Recruiting |
NCT04969731 -
Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer
|
Phase 3 | |
Recruiting |
NCT04927780 -
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
|
Phase 3 | |
Recruiting |
NCT05048524 -
Peri-operative SLOG for Localized Pancreatic Cancer
|
Phase 2 | |
Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT03257150 -
A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer
|
N/A | |
Terminated |
NCT04400903 -
Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer
|
||
Active, not recruiting |
NCT05462717 -
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT03267316 -
A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04970056 -
Pancreatic Cancer Early Detection Consortium
|
||
Terminated |
NCT04046887 -
Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
|
Phase 1 | |
Recruiting |
NCT05964621 -
Venous Thromboembolism in Primary Pancreatic Tumour Resection
|
||
Active, not recruiting |
NCT04827953 -
Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04291651 -
UCSF PANC Cyst Registry
|
||
Recruiting |
NCT05977322 -
A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.
|
Phase 1 | |
Recruiting |
NCT05692596 -
The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
|
||
Active, not recruiting |
NCT04853017 -
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT04862260 -
Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma
|
Early Phase 1 | |
Completed |
NCT03770117 -
Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease
|
||
Completed |
NCT02259114 -
A Dose-Finding Study of Birabresib (MK-8628), a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors (MK-8628-003)
|
Phase 1 |