MSCAN: ctDNA Methylation as Prognostic and Theranostic Tool for Pancreatic Cancer

NCT07045571 | Recruiting

• 1 other identifier: PDAC_LB_2024
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Developing a characteristic ctDNA methylation panel for pancreatic ductal adenocarcinoma and establishing an intelligent diagnostic and dynamic monitoring model based on ctDNA methylation.

Conditions

Pancreatic Neoplasm; Pancreas Cancer

Keywords

Pancreatic ductal adenocarcinoma; Liquid biopsy; CtDNA; DNA methylation; Early diagnosis; Prognosis

Outcome Measures

Primary Outcomes (2)

• Sensitivity and Specificity of ctDNA in Early Screening for Pancreatic Cancer

  Measured using a targeted DNA methylation panel for ctDNA in plasma. The presence or absence of cancer will be confirmed by histopathological diagnosis. Sensitivity and specificity will be calculated using standard diagnostic test evaluation against the gold-standard diagnosis. "Early-stage" is defined as stage I or II pancreatic cancer confirmed by imaging and pathology.

  Up to 2 years from start of study

• Sensitivity and Specificity of ctDNA Methylation Test for Detection of Postoperative Recurrence

  Measured using plasma ctDNA methylation profiles collected at scheduled postoperative time points (e.g., every 3 months). Recurrence will be confirmed by imaging (CT/MRI) or biopsy when clinically indicated. Diagnostic accuracy (sensitivity/specificity) will be evaluated by comparing ctDNA results to confirmed recurrence status.

  Up to 2 years from start of study

Secondary Outcomes (4)

• Progression-Free Survival (PFS) Based on Imaging and Clinical Assessment

  Up to 3 years from start of study

• Overall Survival (OS)

  Up to 3 years from start of study

• Early and Late Imaging Data

  Up to 3 years from start of study

• Levels of Serum Tumor Biomarkers (CA19-9, CEA) in Early-Stage Pancreatic Cancer

  Up to 3 years from start of study

Study Arms (2)

benign

benign pancreatic lesions

malignant

malignant pancreatic lesions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises individuals meeting inclusion criteria and not meeting any exclusion criteria.

You may qualify if:

• Age range between 18 and 80 years old;
• Identification of pancreatic space-occupying lesions through imaging examinations, with a high suspicion of pancreatic malignant tumors and planned for surgical treatment or tissue biopsy for pathological confirmation;
• According to RECIST 1.1 evaluation criteria, having at least one measurable lesion (the longest diameter of the target lesion on spiral CT scan ≥10mm);
• Ability to provide tumor tissue and blood samples;
• Stable vital signs, ECOG score of 0-1;
• Liver function with AST and ALT ≤ 5 times the upper limit of normal (ULN), Child-Pugh classification of A or B; white blood cell count \> 3×10\^9/L, absolute neutrophil count ≥ 1.5×10\^9/L; platelets ≥ 75×10\^9/L; hemoglobin ≥ 90g/L; creatinine clearance rate ≥ 60ml/min; total bilirubin ≤ 3 times ULN;
• Reproductive-age patients and their spouses willing to adopt contraceptive measures; female patients must undergo a pregnancy test (serum or urine) within 7 days before enrollment with a negative result.
• Voluntarily participate in this experimental project, patients with good compliance; if the subject is unable to read or sign, the informed consent form must be signed by a legal representative with the subject's informed consent, and for subjects incapable of expressing consent, the introduction and explanation shall be provided to their legal representative, who will then sign the informed consent form.

You may not qualify if:

• Unable to provide tumor tissue and blood samples;
• Previously received molecular targeted therapy, immunotherapy, or anti-tumor radiochemotherapy before this study;
• History of malignancies other than pancreatic malignancy;
• Presence of other severe diseases, including but not limited to uncontrolled congestive heart failure (NYHA class III or IV), unstable angina, poorly controlled arrhythmias, uncontrolled moderate to severe hypertension (SBP \> 160mmHg or DBP \> 100mmHg);
• Uncontrolled diabetes;
• Active infection;
• Patients with active autoimmune diseases requiring long-term use of steroids;
• Patients who have undergone allogeneic transplantation;
• Active psychiatric disorders affecting informed consent and/or protocol compliance;
• Other severe illnesses deemed inappropriate for participation in this study by investigators.

Sponsors & Collaborators

• Yingbin Liu, MD, PhD, FACS: lead
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Ruijin Hospital: collaborator
• Changhai Hospital: collaborator

Study Sites (1)

Renji hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (2)

• Wu Y, Seufert I, Al-Shaheri FN, Kurilov R, Bauer AS, Manoochehri M, Moskalev EA, Brors B, Tjaden C, Giese NA, Hackert T, Buchler MW, Hoheisel JD. DNA-methylation signature accurately differentiates pancreatic cancer from chronic pancreatitis in tissue and plasma. Gut. 2023 Nov 24;72(12):2344-2353. doi: 10.1136/gutjnl-2023-330155.

  PMID: 37709492 BACKGROUND

• Garcia-Ortiz MV, Cano-Ramirez P, Toledano-Fonseca M, Aranda E, Rodriguez-Ariza A. Diagnosing and monitoring pancreatic cancer through cell-free DNA methylation: progress and prospects. Biomark Res. 2023 Oct 5;11(1):88. doi: 10.1186/s40364-023-00528-y.

  PMID: 37798621 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Pancreatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yinbin Liu, PhD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinbin Liu, PhD

CONTACT

+86 13918803900; laoniulyb@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: July 1, 2025
• Study Start: October 30, 2022
• Primary Completion: January 22, 2026
• Study Completion (Estimated): July 22, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)