Intraductal Papillary Mucinous NeoplasmNCT05433935
Exploring Biomarkers of the Carcinogenesis of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas
An observational study of Intraductal Papillary Mucinous Neoplasm, run by Zhejiang University at 1 site in China.
Trial summary
This is a prospective, open large cohort study to explore biomarkers for detecting early carcinogenesis of IPMN. Read more about this study
- Who is it for?
- Ages 0 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraductal Papillary Mucinous Neoplasm
- What is being tested?
- Observation
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Dec 2033
- 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 0 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients ought to meet all inclusion and exclusion criteria. In addition, the patient of the prospective cohort should be thoroughly informed about the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent of the prospective cohort should be obtained from the patient prior to enrollment.
Who may be able to join
- clinically diagnosed as IPMN;
- without other malignant tumor;
- agree to sign informed consent.
Who cannot join
- with mental disorders which can affect cognition and cooperation;
- with serious blood diseases or taking drugs that can affect peripheral blood
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
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Qi Zhang, 13858108798
About this study
Official title: A Prospective, Open Large Cohort Study of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas
This is a prospective, open large cohort study to explore biomarkers for detecting early carcinogenesis of IPMN.
Read the detailed description
This prospective study was designed to explore biomarkers for detecting early carcinogenesis of IPMN. This study intends to prospectively and continuously enroll IPMN patients, and regularly collect biological samples including blood, urine, feces and saliva. We aimed to detect biomarkers which can predict the carcinogenesis of IPMN by multi-omics. The primary endpoint is the predictive accuracy of biomarkers for IPMN malignant transformation. The probability of IPMN malignant transformation , rates of surgical resection and survival after surgery are secondary endpoints.
- Conditions
- Intraductal Papillary Mucinous Neoplasm
- Being tested
- Observation
- Keywords
- intraductal papillary mucinous neoplasm, biomarkers, prospective cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Prospective IPMN cohort | Multi-omics analysis of 5000 prospectively collected samples. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of IPMN malignant transformation
Measured: Up to 10 years
Secondary outcomes (3)
the probability of IPMN malignant transformation
Measured: Up to 10 years
rates of surgical resection
Measured: Up to 10 years
survival after surgery
Measured: Up to 10-15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2032 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraductal Papillary Mucinous NeoplasmStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Second Affiliated Hospital of Nanchang University, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Huizhou Municipal Central Hospital
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
- Investigators
- Tingbo Liang, PhD, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433935
- Sponsor's protocol ID
- PCIPMN
- Status last verified
- Jan 2023
- First submitted
- 22 Jun 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Large Cohort Study of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas
- ClinicalTrials.gov ID
- NCT05433935
- Acronym / sponsor ID
- PCIPMN
- Conditions
- Intraductal Papillary Mucinous Neoplasm
- Keywords
- intraductal papillary mucinous neoplasm, biomarkers, prospective cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Second Affiliated Hospital of Nanchang University, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Huizhou Municipal Central Hospital
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2032 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 27 Jun 2022 (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.
This is a prospective, open large cohort study to explore biomarkers for detecting early carcinogenesis of IPMN.
Detailed description
This prospective study was designed to explore biomarkers for detecting early carcinogenesis of IPMN. This study intends to prospectively and continuously enroll IPMN patients, and regularly collect biological samples including blood, urine, feces and saliva. We aimed to detect biomarkers which can predict the carcinogenesis of IPMN by multi-omics. The primary endpoint is the predictive accuracy of biomarkers for IPMN malignant transformation. The probability of IPMN malignant transformation , rates of surgical resection and survival after surgery are secondary endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective IPMN cohort | – | Other: ObservationMulti-omics analysis of 5000 prospectively collected samples. |
Who may qualify
- Ages
- 0 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients ought to meet all inclusion and exclusion criteria. In addition, the patient of the prospective cohort should be thoroughly informed about the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent of the prospective cohort should be obtained from the patient prior to enrollment.
Key inclusion criteria (3 listed)
- clinically diagnosed as IPMN;
- without other malignant tumor;
- agree to sign informed consent.
Key exclusion criteria (2 listed)
- with mental disorders which can affect cognition and cooperation;
- with serious blood diseases or taking drugs that can affect peripheral blood
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 |
|---|---|---|
| ObservationThis is an observational study. | Other | Prospective IPMN cohort |
Primary outcome
The accuracy of IPMN malignant transformation
Time frame: Up to 10 years
3 secondary outcomes
the probability of IPMN malignant transformation
Time frame: Up to 10 years
rates of surgical resection
Time frame: Up to 10 years
survival after surgery
Time frame: Up to 10-15 years
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 27 Jan 2023.
- 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.
Tingbo Liang, PhD study chair
Zhejiang University
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 Intraductal Papillary Mucinous Neoplasm, run by Zhejiang University 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 3 inclusion and 2 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 27 Jan 2023. 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 Tingbo Liang, PhD (+86 19941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of IPMN malignant transformation (time frame: Up to 10 years). 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 27 Jan 2023.