Pancreatic NeoplasmsNCT05737953
Construction of Molecular Diagnostic Marker Model for Pancreatic Cystic Tumors Based on Pancreatic Cystic Fluid Samples
An observational study of Pancreatic Neoplasms and DNA Methylation, run by Zhaoshen Li at 1 site in China.
Trial summary
The goal of this observational study is to test in patients with cystic tumor of pancreas. The main questions it aims to answer are: Screening of molecular diagnostic markers for pancreatic cystic tumors by cfDNA methylation sequencing of pancreatic cystic fluid and proteomic assays to distinguish benign from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, DNA Methylation, Proteome
- What is being tested?
- cfDNA methylation sequencing and proteome analysis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic cystic tumor
Who may be able to join
- Subjects are ≥ 18 years old, regardless of gender;
- Preoperative imaging examination (EUS, CT, MRI) diagnosed cystic mass of pancreas and suspected cystic tumor;
- Subjects voluntarily accepted radical resection of pancreatic cystic tumors;
- Subjects or family members voluntarily sign the informed consent form for clinical research.
Who cannot join
- The excised sample does not contain cystic components, or the cystic fluid cannot be collected;
- Receive tumor-related treatment (radiotherapy, chemotherapy, immunotherapy, etc.) before operation;
- Receive antibiotic treatment within 1 week before operation;
- Subjects refused to accept radical resection of pancreatic cystic tumor, or had any situation that they could not accept radical resection of pancreatic cystic tumor;
- The subjects or their families refused to sign the informed consent form for clinical research.
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
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Kaixuan Wang, MD, 86-21-31161353, wangkaixuan224007@sina.com
About this study
Official title: Construction of Molecular Diagnostic Marker Models for Pancreatic Cystic Tumors Based on CfDNA Methylation Sequencing and Proteomic Analysis of Pancreatic Cystic Fluid Samples
The goal of this observational study is to test in patients with cystic tumor of pancreas. The main questions it aims to answer are:
Screening of molecular diagnostic markers for pancreatic cystic tumors by cfDNA methylation sequencing of pancreatic cystic fluid and proteomic assays to distinguish benign from malignant and mucinous/non-mucinous, correlate with pathological features, and find molecular features associated with the degree of malignancy.
Participants will Provide post-operative cyst fluid specimens.
Read the detailed description
Patients with pancreatic cystic tumors were divided into control, mucinous tumor and non-mucinous tumor groups, and cfDNA molecules and protein molecules that were significantly altered between different groups were found by cfDNA methylation sequencing of pancreatic cystic fluid and proteomic detection techniques. Multi-omics analysis was performed to construct a more efficient molecular diagnostic marker model. Correlating models with pathological features to find molecular features associated with the degree of malignancy.
- Conditions
- Pancreatic Neoplasms, DNA Methylation, Proteome
- Being tested
- cfDNA methylation sequencing and proteome analysis
- Keywords
- Pancreas cystic neoplasm
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cfDNA methylation sequencing and proteome analysisDiagnostic test
Sequencing of cfDNA methylation and proteomic analysis of two sets of capsular fluid samples
| Study group | Role | What they receive |
|---|---|---|
| Mucinous tumour group | Not described Receives: Diagnostic Test: cfDNA methylation sequencing and proteome analysis | |
| Non-mucinous tumour group | Not described Receives: Diagnostic Test: cfDNA methylation sequencing and proteome analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types and concentrations of cfDNA and proteins contained in the vesicular fluid
Identification of protein and circulating gene methylation species in cyst fluid and quantification of their concentrations using mass spectrometry. Characterize cfDNA methylation and proteomics of cyst fluid in patients with pancreatic cystic neoplasm (PCN).
Measured: 2023-11-31
Secondary outcomes (3)
Establishment of a diagnostic model for cystic tumors of the pancreas
A machine learning approach was used to further screen for characteristically methylated cfDNA and proteins in PCN patients.Establishment of a diagnostic model for pancreatic cystic tumors.
Measured: 2023-11-31
Establishing a model for the identification of mucus and non-mucus
A machine learning approach was used to further screen for characteristically methylated cfDNA and proteins in PCN patients.To establish a model for the identification of mucinous and non-mucinous.
Measured: 2023-11-31
Development of a progressive benign malignancy prediction model
A machine learning approach was used to further screen for characteristically methylated cfDNA and proteins in PCN patients.Development of a progression benign malignancy prediction model.
Measured: 2023-11-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhaoshen Li
- Sponsor type
- University, hospital or other
- Collaborators
- Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Nanchang University, West China Hospital, LanZhou University, First Affiliated Hospital Xi'an Jiaotong University, Peking University Cancer Hospital & Institute, First Hospital of China Medical University, First Affiliated Hospital of Guangxi Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second Affiliated Hospital of Baotou Medical College, Shandong Province Third hospital
- Responsible party
- Sponsor-investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Shiyu Li, Principal investigator, Changhai HospitalChengye Pan, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737953
- Sponsor's protocol ID
- WKX2023-02
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2023
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: cfDNA methylation data and proteome analysis data
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Molecular Diagnostic Marker Models for Pancreatic Cystic Tumors Based on CfDNA Methylation Sequencing and Proteomic Analysis of Pancreatic Cystic Fluid Samples
- ClinicalTrials.gov ID
- NCT05737953
- Acronym / sponsor ID
- WKX2023-02
- Conditions
- Pancreatic Neoplasms, DNA Methylation, Proteome
- Keywords
- Pancreas cystic neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhaoshen LiUniversity, hospital or other
- Collaborators
- Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Nanchang University, West China Hospital, LanZhou University, First Affiliated Hospital Xi'an Jiaotong University, Peking University Cancer Hospital & Institute, First Hospital of China Medical University, First Affiliated Hospital of Guangxi Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second Affiliated Hospital of Baotou Medical College, Shandong Province Third hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 21 Feb 2023 (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.
The goal of this observational study is to test in patients with cystic tumor of pancreas. The main questions it aims to answer are:
Screening of molecular diagnostic markers for pancreatic cystic tumors by cfDNA methylation sequencing of pancreatic cystic fluid and proteomic assays to distinguish benign from malignant and mucinous/non-mucinous, correlate with pathological features, and find molecular features associated with the degree of malignancy.
Participants will Provide post-operative cyst fluid specimens.
Detailed description
Patients with pancreatic cystic tumors were divided into control, mucinous tumor and non-mucinous tumor groups, and cfDNA molecules and protein molecules that were significantly altered between different groups were found by cfDNA methylation sequencing of pancreatic cystic fluid and proteomic detection techniques. Multi-omics analysis was performed to construct a more efficient molecular diagnostic marker model. Correlating models with pathological features to find molecular features associated with the degree of malignancy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucinous tumour group | – | Diagnostic Test: cfDNA methylation sequencing and proteome analysis |
| Non-mucinous tumour group | – | Diagnostic Test: cfDNA methylation sequencing and proteome analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic cystic tumor
Key inclusion criteria (4 listed)
- Subjects are ≥ 18 years old, regardless of gender;
- Preoperative imaging examination (EUS, CT, MRI) diagnosed cystic mass of pancreas and suspected cystic tumor;
- Subjects voluntarily accepted radical resection of pancreatic cystic tumors;
- Subjects or family members voluntarily sign the informed consent form for clinical research.
Key exclusion criteria (5 listed)
- The excised sample does not contain cystic components, or the cystic fluid cannot be collected;
- Receive tumor-related treatment (radiotherapy, chemotherapy, immunotherapy, etc.) before operation;
- Receive antibiotic treatment within 1 week before operation;
- Subjects refused to accept radical resection of pancreatic cystic tumor, or had any situation that they could not accept radical resection of pancreatic cystic tumor;
- The subjects or their families refused to sign the informed consent form for clinical research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cfDNA methylation sequencing and proteome analysisSequencing of cfDNA methylation and proteomic analysis of two sets of capsular fluid samples | Diagnostic test | Mucinous tumour group, Non-mucinous tumour group |
Primary outcome
Types and concentrations of cfDNA and proteins contained in the vesicular fluid
Time frame: 2023-11-31
Identification of protein and circulating gene methylation species in cyst fluid and quantification of their concentrations using mass spectrometry. Characterize cfDNA methylation and proteomics of cyst fluid in patients with pancreatic cystic neoplasm (PCN).
3 secondary outcomes
Establishment of a diagnostic model for cystic tumors of the pancreas
Time frame: 2023-11-31
Establishing a model for the identification of mucus and non-mucus
Time frame: 2023-11-31
Development of a progressive benign malignancy prediction model
Time frame: 2023-11-31
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 11 Feb 2025.
- Individual participant dataSharing planned: Undecided. cfDNA methylation data and proteome analysis data
Related trials for Pancreatic Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Shiyu Li principal investigator
Changhai Hospital
Chengye Pan study chair
Changhai 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 Neoplasms and DNA Methylation, run by Zhaoshen Li 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 4 inclusion and 5 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 11 Feb 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 Kaixuan Wang (021-31166666, lizfish@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Types and concentrations of cfDNA and proteins contained in the vesicular fluid (time frame: 2023-11-31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2025.