Chronic PancreatitisNCT04574297
An Observational Study on the Natural Course of Chronic Pancreatitis
An observational study of Chronic Pancreatitis and Genetic Mutation, run by Changhai Hospital.
Trial summary
To explore the impact on genetic and environmental factors for clinical manifestation, and the progression of chronic pancreatitis, including development of pancreatic insufficiency and other complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis, Genetic Mutation, Smoking, Tobacco
- What is being tested?
- smoking and alcohol assumption and genetic sequencing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 798 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Consequent patients with a diagnosis of CP in Changhai Hospital between 2010 to 2014
Who may be able to join
- patients with a diagnosis of chronic pancreatitis
- agree to join the study and provide informed consent
Who cannot join
- autoimmune pancreatitis
- pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
- the follow-up time less than 2 years
- patients presenting with diabetes and/or steatorrhea at onset of CP.
About this study
Official title: The Impact of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis：An Observational Study
To explore the impact on genetic and environmental factors for clinical manifestation, and the progression of chronic pancreatitis, including development of pancreatic insufficiency and other complications.
Read the detailed description
The present study was an observational study aimed to explore the impact of genetic factors (rare pathogenic variants of CP) and environmental factors(smoking and alcohol assumption) on the clinical manifestation and progression of CP. The observation items included the pain patterns, incidence of complications of CP, pancreatic cancer and death.
- Being tested
- smoking and alcohol assumption, genetic sequencing
- Medical subject headings
- Pancreatitis, Chronic, Tobacco Smoking, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking and alcohol assumptionBehavioural
documenting the change of smoking and drinking status during the follow-up period
genetic sequencingDiagnostic test
sequencing the susceptibility genes for CP, including serine protease inhibitor Kazal type 1, cationic trypsinogen, cystic fibrosis transmembrane conductance regulator, chymotrypsin C, etc.
What is being measured
The primary outcome is the main question the study is designed to answer.
the Number of Patients Developing Pancreatic Insufficiency
The primary endpoint was the number of patients developing pancreatic insufficiency, categorised as 1) diabetes and steatorrhea, 2) diabetes only, or 3) steatorrhea only.
Measured: 10 years
Secondary outcomes (1)
Death
all-cause death
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jan 2011
- Primary completion31 May 2020
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 798 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574297
- Sponsor's protocol ID
- CP-2011
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2020
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ru N, Xu XN, Cao Y, Zhu JH, Hu LH, Wu SY, Qian YY, Pan J, Zou WB, Li ZS, Liao Z. The Impacts of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1378-e1387. doi: 10.1016/j.cgh.2021.08.033. Epub 2021 Aug 28.
PubMed 34461303
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis：An Observational Study
- ClinicalTrials.gov ID
- NCT04574297
- Acronym / sponsor ID
- CP-2011
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 798 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Posted 30 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the impact on genetic and environmental factors for clinical manifestation, and the progression of chronic pancreatitis, including development of pancreatic insufficiency and other complications.
Detailed description
The present study was an observational study aimed to explore the impact of genetic factors (rare pathogenic variants of CP) and environmental factors(smoking and alcohol assumption) on the clinical manifestation and progression of CP. The observation items included the pain patterns, incidence of complications of CP, pancreatic cancer and death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consequent patients with a diagnosis of CP in Changhai Hospital between 2010 to 2014
Key inclusion criteria (2 listed)
- patients with a diagnosis of chronic pancreatitis
- agree to join the study and provide informed consent
Key exclusion criteria (4 listed)
- autoimmune pancreatitis
- pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
- the follow-up time less than 2 years
- patients presenting with diabetes and/or steatorrhea at onset of CP.
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 |
|---|---|---|
| smoking and alcohol assumptiondocumenting the change of smoking and drinking status during the follow-up period | Behavioural | – |
| genetic sequencingsequencing the susceptibility genes for CP, including serine protease inhibitor Kazal type 1, cationic trypsinogen, cystic fibrosis transmembrane conductance regulator, chymotrypsin C, etc. | Diagnostic test | – |
Primary outcome
the Number of Patients Developing Pancreatic Insufficiency
Time frame: 10 years
The primary endpoint was the number of patients developing pancreatic insufficiency, categorised as 1) diabetes and steatorrhea, 2) diabetes only, or 3) steatorrhea only.
1 secondary outcome
Death
Time frame: 20 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34461303Ru N, Xu XN, Cao Y, Zhu JH, Hu LH, Wu SY, Qian YY, Pan J, Zou WB, Li ZS, Liao Z. The Impacts of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1378-e1387. doi: 10.1016/j.cgh.2021.08.033. Epub 2021 Aug 28.
- Individual participant dataSharing planned: Undecided
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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 Chronic Pancreatitis and Genetic Mutation, run by Changhai 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Nov 2021. 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?
Yes. Results are posted in the registry (first posted 30 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
the Number of Patients Developing Pancreatic Insufficiency (time frame: 10 years). 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 NCT04574297, which also lists 1 linked publication.
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 30 Nov 2021.