Pancreatic MassesNCT06724055
Diagnostic Prediction of Pancreatic Masses
An observational study of Pancreatic Masses, run by Peking Union Medical College Hospital.
Trial summary
The goal of this observational study is to learn if a strategy can be developed for differentiating autoimmune pancreatitis (AIP) and primary pancreatic lymphoma (PPL) from pancreatic ductal adenocarcinoma (PDAC) in patients presenting with pancreatic masses. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Masses
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2002to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Inpatients in Peking Union Medical College Hospital.
Who may be able to join
- Inpatients presenting with pancreatic masses and eventually diagnosed with PPL, AIP, or PDAC (confirmed by pathologic results).
Who cannot join
None listed.
About this study
Official title: Diagnostic Prediction of Pancreatic Masses: How to Avoid an Unnecessary Resection
The goal of this observational study is to learn if a strategy can be developed for differentiating autoimmune pancreatitis (AIP) and primary pancreatic lymphoma (PPL) from pancreatic ductal adenocarcinoma (PDAC) in patients presenting with pancreatic masses. The main question it aims to answer is:
What features, in the perspectives of clinical manifestation, laboratory tests, and imaging, can differentiate different kinds of pancreatic masses (AIP, PPL and PDAC)?
Participants will not be given any interventions since this is a retrospective observational study.
- Conditions
- Pancreatic Masses
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 |
|---|---|---|
| AIP | Not described | |
| PPL | Not described | |
| PDAC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic nomogram
Measured: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
Secondary outcomes (4)
serum level of LDH
Measured: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
serum level of IgG4
Measured: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
largest diameter of pancreatic masses
Measured: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
dilation of pancreatic duct
Measured: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2002
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic MassesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724055
- Sponsor's protocol ID
- 2024-DPPM
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 9 Dec 2024
- 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 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Prediction of Pancreatic Masses: How to Avoid an Unnecessary Resection
- ClinicalTrials.gov ID
- NCT06724055
- Acronym / sponsor ID
- 2024-DPPM
- Conditions
- Pancreatic Masses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 9 Dec 2024 (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 learn if a strategy can be developed for differentiating autoimmune pancreatitis (AIP) and primary pancreatic lymphoma (PPL) from pancreatic ductal adenocarcinoma (PDAC) in patients presenting with pancreatic masses. The main question it aims to answer is:
What features, in the perspectives of clinical manifestation, laboratory tests, and imaging, can differentiate different kinds of pancreatic masses (AIP, PPL and PDAC)?
Participants will not be given any interventions since this is a retrospective observational study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AIP | – | – |
| PPL | – | – |
| PDAC | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatients in Peking Union Medical College Hospital.
Key inclusion criteria (1 listed)
- Inpatients presenting with pancreatic masses and eventually diagnosed with PPL, AIP, or PDAC (confirmed by pathologic results).
Key exclusion criteria (0 listed)
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
Diagnostic nomogram
Time frame: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
4 secondary outcomes
serum level of LDH
Time frame: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
serum level of IgG4
Time frame: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
largest diameter of pancreatic masses
Time frame: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
dilation of pancreatic duct
Time frame: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Masses, run by Peking Union Medical College Hospital.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic nomogram (time frame: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months). 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 9 Dec 2024.