Pancreatic NeoplasmNCT07045571
MSCAN: ctDNA Methylation as Prognostic and Theranostic Tool for Pancreatic Cancer
An observational study of Pancreatic Neoplasm and Pancreas Cancer, run by Yingbin Liu, MD, PhD, FACS at 1 site in China.
Trial summary
Developing a characteristic ctDNA methylation panel for pancreatic ductal adenocarcinoma and establishing an intelligent diagnostic and dynamic monitoring model based on ctDNA methylation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Neoplasm, Pancreas Cancer
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2022to 22 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population comprises individuals meeting inclusion criteria and not meeting any exclusion criteria.
Who may be able to join
- Patients meeting all inclusion criteria are eligible to enter this study, including but not limited to:
- 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;
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- 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.
Who cannot join
- Patients meeting any of the exclusion criteria will not be eligible for inclusion, including but not limited to:
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Yingbin Liu, PHD, 13918803900, laoniulyb@163.com
About this study
Official title: Methylation Signature of Circulating Tumour DNA as a Prognostic and Theranostic Tool for Managing Pancreatic Ductal Adenocarcinoma
Developing a characteristic ctDNA methylation panel for pancreatic ductal adenocarcinoma and establishing an intelligent diagnostic and dynamic monitoring model based on ctDNA methylation.
Read the 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
- Keywords
- Pancreatic ductal adenocarcinoma, Liquid biopsy, CtDNA, DNA methylation, Early diagnosis, Prognosis
- Medical subject headings
- Pancreatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| benign | benign pancreatic lesions | |
| malignant | malignant pancreatic lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 years from start of study
Secondary outcomes (4)
Progression-Free Survival (PFS) Based on Imaging and Clinical Assessment
PFS 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.
Measured: 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.
Measured: Up to 3 years from start of study
Early and Late Imaging Data
CT 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.
Measured: Up to 3 years from start of study
Levels of Serum Tumor Biomarkers (CA19-9, CEA) in Early-Stage Pancreatic Cancer
Serum 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.
Measured: Up to 3 years from start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start30 Oct 2022
- Primary completion22 Jan 2026 (estimated)
- Study completion22 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yingbin Liu, MD, PhD, FACS
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, Changhai Hospital
- Responsible party
- Sponsor-investigator, Yingbin Liu, MD, PhD, FACS, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yinbin Liu, PhD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045571
- Sponsor's protocol ID
- PDAC_LB_2024
- Status last verified
- Jun 2025
- First submitted
- 8 May 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37709492Garcia-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.
PubMed 37798621
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylation Signature of Circulating Tumour DNA as a Prognostic and Theranostic Tool for Managing Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07045571
- Acronym / sponsor ID
- PDAC_LB_2024
- Conditions
- Pancreatic Neoplasm, Pancreas Cancer
- Keywords
- Pancreatic ductal adenocarcinoma, Liquid biopsy, CtDNA, DNA methylation, Early diagnosis, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yingbin Liu, MD, PhD, FACSUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, Changhai Hospital
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 22 Jan 2026 (estimated)
- Study completion
- 22 Jul 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benign | – | –benign pancreatic lesions |
| malignant | – | –malignant pancreatic lesions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises individuals meeting inclusion criteria and not meeting any exclusion criteria.
Key inclusion criteria (9 listed)
- Patients meeting all inclusion criteria are eligible to enter this study, including but not limited to:
- 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;
Key exclusion criteria (11 listed)
- Patients meeting any of the exclusion criteria will not be eligible for inclusion, including but not limited to:
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and Specificity of ctDNA in Early Screening for Pancreatic Cancer
Time frame: Up to 2 years from start of study
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.
Sensitivity and Specificity of ctDNA Methylation Test for Detection of Postoperative Recurrence
Time frame: Up to 2 years from start of study
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.
4 secondary outcomes
Progression-Free Survival (PFS) Based on Imaging and Clinical Assessment
Time frame: Up to 3 years from start of study
Overall Survival (OS)
Time frame: Up to 3 years from start of study
Early and Late Imaging Data
Time frame: Up to 3 years from start of study
Levels of Serum Tumor Biomarkers (CA19-9, CEA) in Early-Stage Pancreatic Cancer
Time frame: Up to 3 years from start of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Background: PubMed 37709492Wu 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.
- Background: PubMed 37798621Garcia-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yinbin Liu, PhD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasm and Pancreas Cancer, run by Yingbin Liu, MD, PhD, FACS at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yinbin Liu, PhD (+86 13918803900, laoniulyb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of ctDNA in Early Screening for Pancreatic Cancer (time frame: Up to 2 years from start of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07045571, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.