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

NCT ID: NCT07045571

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-30
• Study Completion Date: 2026-07-22

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.

Detailed Description

Pancreatic cancer is a digestive system malignancy characterized by late clinical detection, high malignancy, and poor prognosis. Exploring economically viable, accurate, and minimally invasive methods for early diagnosis and postoperative monitoring is of significant clinical importance to facilitate early screening and improve patient outcomes. Liquid biopsy, which involves detecting various tumor-related biomarkers in extractable bodily fluids, such as circulating tumor cells, circulating tumor DNA, and exosomes, plays a crucial role in the early diagnosis and prognosis of pancreatic cancer.

Recent research indicates the substantial impact of liquid biopsy in the early diagnosis and prognosis of pancreatic cancer. Differential methylation regions in ctDNA, as opposed to ctDNA mutations, show promise as potential markers. Aberrant DNA methylation has been demonstrated to be more frequent than DNA mutations in tumor development and often occurs early in carcinogenesis. In this project, whole-genome methylation signal scans are conducted on blood samples and tumor tissue samples from pancreatic cancer using next-generation sequencing. The goal is to identify tumor-specific methylation biomarker sites. Subsequently, targeted sequencing is performed on ctDNA based on these identified sites.

Conditions

Pancreatic Neoplasm; Pancreas Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

benign

benign pancreatic lesions

No interventions assigned to this group

malignant

malignant pancreatic lesions

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age range between 18 and 80 years old;

2. 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;

3. 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);

4. Ability to provide tumor tissue and blood samples;

5. Stable vital signs, ECOG score of 0-1;

6. 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;

7. 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.

8. 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.

Exclusion Criteria

1. Unable to provide tumor tissue and blood samples;

2. Previously received molecular targeted therapy, immunotherapy, or anti-tumor radiochemotherapy before this study;

3. History of malignancies other than pancreatic malignancy;

4. 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);

5. Uncontrolled diabetes;

6. Active infection;

7. Patients with active autoimmune diseases requiring long-term use of steroids;

8. Patients who have undergone allogeneic transplantation;

9. Active psychiatric disorders affecting informed consent and/or protocol compliance;

10. Other severe illnesses deemed inappropriate for participation in this study by investigators.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Changhai Hospital

OTHER

Sponsor Role: collaborator

Yingbin Liu, MD, PhD, FACS

OTHER

Sponsor Role: lead

Responsible Party

Yingbin Liu, MD, PhD, FACS

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yinbin Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

Renji hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yinbin Liu, PhD

Role: CONTACT

laoniulyb@163.com

+86 13918803900

Facility Contacts

Yingbin Liu, PHD

Role: primary

laoniulyb@163.com

13918803900

References

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.

Reference Type: BACKGROUND

PMID: 37709492 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37798621 (View on PubMed)

Other Identifiers

PDAC_LB_2024

Identifier Type: -

Identifier Source: org_study_id