Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smoking and alcohol assumption | Behavioral | documenting the change of smoking and drinking status during the follow-up period | ||
| genetic sequencing | Diagnostic Test | sequencing the susceptibility genes for CP, including serine protease inhibitor Kazal type 1, cationic trypsinogen, cystic fibrosis transmembrane conductance regulator, chymotrypsin C, etc. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Death | all-cause death | 20 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Consequent patients with a diagnosis of CP in Changhai Hospital between 2010 to 2014
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34461303 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | G+/E+ Group | Genetic factor/s positive and environmental factor/s positive group. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
| FG001 | G-/E+ Group | Genetic factor/s negative and environmental factor/s positive group.Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
| FG002 | G+/E- Group | Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
| FG003 | G-/E- Group | Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | G+/E+ Group | Genetic factor/s positive and environmental factor/s positive group. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 10 years |
|
10 years.
The definition of adverse event and/or serious adverse event is in accordance with the clinicaltrials.gov Definitions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | G+/E+ Group | genetic factor/s positive and environmental factor/s positive group Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zhuan Liao | Changhai Hospital | 86-21-31161004 | liaozhuan@smmu.edu.cn |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2020 | Sep 28, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D000073869 | Tobacco Smoking |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
The remained peripheral blood sample after laboratory examinations.
| G-/E+ Group |
Genetic factor/s negative and environmental factor/s positive group.Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
| BG002 | G+/E- Group | Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
| BG003 | G-/E- Group | Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | G+/E- Group | Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
| OG003 | G-/E- Group | Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
|
|
| Secondary | Death | all-cause death | Not Posted | 20 years | Participants |
| 6 |
| 180 |
| 0 |
| 180 |
| 0 |
| 180 |
| EG001 | G-/E+ Group | genetic factor/s negative and environmental factor/s positive group Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | 9 | 263 | 0 | 263 | 0 | 263 |
| EG002 | G+/E- Group | genetic factor/s positive group and environmental factor/s negative Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | 4 | 230 | 0 | 230 | 0 | 230 |
| EG003 | G-/E- Group | genetic factor/s negative group and environmental factor/s negative | 5 | 125 | 0 | 125 | 0 | 125 |
Not provided
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D004327 | Drinking Behavior |