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

2022-10-30

2026-01-22

2026-07-22

1000

Study Overview

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

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

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.

  • Pancreatic Neoplasm
  • Pancreas Cancer
    • PDAC_LB_2024

    Study Record Dates

    These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

    Study Registration Dates Results Reporting Dates Study Record Updates

    2025-05-08  

    N/A  

    2025-06-29  

    2025-06-29  

    N/A  

    2025-07-01  

    2025-07-01  

    N/A  

    2025-06  

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    Design Details

    Primary Purpose:
    N/A

    Allocation:
    N/A

    Interventional Model:
    N/A

    Masking:
    N/A

    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    : benign

    benign pancreatic lesions

    : malignant

    malignant pancreatic lesions

    Primary Outcome MeasuresMeasure DescriptionTime Frame
    Sensitivity and Specificity of ctDNA in Early Screening for Pancreatic CancerMeasured 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 RecurrenceMeasured 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 Outcome MeasuresMeasure DescriptionTime Frame
    Progression-Free Survival (PFS) Based on Imaging and Clinical AssessmentPFS will be calculated from the date of enrollment to the date of disease progression or death from any cause. Disease progression will be assessed using RECIST 1.1 criteria via CT/MRI scans performed every 3-6 months.Up to 3 years from start of study
    Overall Survival (OS)Overall survival will be defined as the time from enrollment to death from any cause. Survival status will be monitored every 3 months through clinic visits or phone follow-up.Up to 3 years from start of study
    Early and Late Imaging DataCT and/or MRI imaging will be used to measure tumor size, vascular invasion, and metastasis at baseline and every 3-6 months. Data will be used to assess tumor response, progression, or recurrence.Up to 3 years from start of study
    Levels of Serum Tumor Biomarkers (CA19-9, CEA) in Early-Stage Pancreatic CancerSerum levels of CA19-9 and CEA will be measured at baseline and during follow-up visits using standard immunoassays. Biomarker trends will be analyzed to assess correlation with disease stage, treatment response, and recurrence.Up to 3 years from start of study

    Contacts and Locations

    This section provides the contact details for those conducting the study, and information on where this study is being conducted.

    Study Contact

    Name: Yinbin Liu, PhD

    Phone Number: +86 13918803900

    Email: laoniulyb@163.com

    Participation Criteria

    Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:

    Accepts Healthy Volunteers:

      Inclusion Criteria:
      Patients meeting all inclusion criteria are eligible to enter this study, including but not limited to:
      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:
      Patients meeting any of the exclusion criteria will not be eligible for inclusion, including but not limited to:
      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.

    Collaborators and Investigators

    This is where you will find people and organizations involved with this study.

    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    • Ruijin Hospital
    • Changhai Hospital
    • PRINCIPAL_INVESTIGATOR: Yinbin Liu, PhD, RenJi Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • 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.
    • 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.
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