Chronic PancreatitisNCT06055595
Genetic Factors and CP Pregnancy Outcomes
An observational study of Chronic Pancreatitis and Genetic Mutation, run by Changhai Hospital at 1 site in China.
Trial summary
To explore the impact of chronic pancreatitis (CP) susceptibility genes on pregnancy outcomes. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Chronic Pancreatitis, Genetic Mutation, Pregnancy Related
- What is being tested?
- genetic sequencing
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to 31 Dec 2024
- How long will I take part?
- 14 Years
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: There were 292 female patients diagnosed with CP and underwent genetic testing from January 2010 to December 2014 in this cohort. After application of exclusion criteria, a total of 160 patients who had known genetic backgrounds and pregnancy history were enrolled in this study.
Who may be able to join
- female patients with a diagnosis of chronic pancreatitis
- have known genetic backgrounds and pregnancy history
- agree to join the study and provide informed consent
Who cannot join
- patients without documented pregnancy
- patients who denied to provide pregnancy-related information, or with incomplete pregnancy characteristics and/or outcomes
- patients with other autoimmune comorbidities that might influence pregnancy outcomes, such as systemic lupus erythematosus, autoimmune thyroid diseases, etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Genetic Factors on Pregnancy Outcomes in Chronic Pancreatitis
To explore the impact of chronic pancreatitis (CP) susceptibility genes on pregnancy outcomes.
Read the detailed description
The goal of this observational study is to explore the impact of CP susceptibility genes (SPINK1, PRSS1, CTRC, CFTR) on pregnancy outcomes (including both maternal and fetal outcomes) in a large Chinese cohort. Participants will be asked to provide their pregnancy-related data.
- Conditions
- Chronic Pancreatitis, Genetic Mutation, Pregnancy Related
- Being tested
- genetic sequencing
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
adverse maternal outcomes of female CP patients
- CP-associated caesarean delivery referred to caesarean deliveries which happened due to the attack of CP or comorbidities associated with CP such as GDM and HDP.
- CP-associated preterm delivery was defined as preterm deliveries which happened due to the attack of CP or comorbidities associated with CP.
- GDM was defined as the onset or first recognition of abnormal glucose tolerance during pregnancy.
- Intrahepatic cholestasis of pregnancy was based on characteristic symptoms, as well as elevated serum bile acids, in the absence of other hepatobiliary disease.
- HDP included preeclampsia/eclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, and gestational hypertension.
Measured: through study completion, an average of 1 year
adverse fetal outcomes of female CP patients
- Low birth weight was defined as weight at birth <2500 g.
- CP-associated abortion referred to abortions (i.e., a nonviable intrauterine pregnancy up to 20 weeks' gestation) which happened due to the attack of CP or comorbidities associated with CP.
- Congenital anomaly referred to the inborn errors of development.
- Stillbirth was defined as the delivery of a fetus ≥20 weeks of gestation with no signs of life.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study startJan 2010
- Primary completion31 May 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 160 participants (actual)
- Target duration
- 14 Years
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhuan Liao, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055595
- Sponsor's protocol ID
- CP-gene-pregnancy outcomes
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu D, Ru N, Wang YC, Ma GX, Shi TY, Xiong SH, You AJ, Wang L, Hu LH, Li ZS, Zou WB, Liao Z. Genetic Factors Associated With Adverse Pregnancy Outcomes in Chronic Pancreatitis. Clin Transl Gastroenterol. 2024 Apr 1;15(4):e00691. doi: 10.14309/ctg.0000000000000691.
PubMed 38334943
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Genetic Factors on Pregnancy Outcomes in Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT06055595
- Acronym / sponsor ID
- CP-gene-pregnancy outcomes
- Conditions
- Chronic Pancreatitis, Genetic Mutation, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Sep 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.
To explore the impact of chronic pancreatitis (CP) susceptibility genes on pregnancy outcomes.
Detailed description
The goal of this observational study is to explore the impact of CP susceptibility genes (SPINK1, PRSS1, CTRC, CFTR) on pregnancy outcomes (including both maternal and fetal outcomes) in a large Chinese cohort. Participants will be asked to provide their pregnancy-related data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Years
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- There were 292 female patients diagnosed with CP and underwent genetic testing from January 2010 to December 2014 in this cohort. After application of exclusion criteria, a total of 160 patients who had known genetic backgrounds and pregnancy history were enrolled in this study.
Key inclusion criteria (3 listed)
- female patients with a diagnosis of chronic pancreatitis
- have known genetic backgrounds and pregnancy history
- agree to join the study and provide informed consent
Key exclusion criteria (3 listed)
- patients without documented pregnancy
- patients who denied to provide pregnancy-related information, or with incomplete pregnancy characteristics and/or outcomes
- patients with other autoimmune comorbidities that might influence pregnancy outcomes, such as systemic lupus erythematosus, autoimmune thyroid diseases, etc
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 |
|---|---|---|
| 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
adverse maternal outcomes of female CP patients
Time frame: through study completion, an average of 1 year
* CP-associated caesarean delivery referred to caesarean deliveries which happened due to the attack of CP or comorbidities associated with CP such as GDM and HDP. * CP-associated preterm delivery was defined as preterm deliveries which happened due to the attack of CP or comorbidities associated with CP. * GDM was defined as the onset or first recognition of abnormal glucose tolerance during pregnancy. * Intrahepatic cholestasis of pregnancy was based on characteristic symptoms, as well as elevated serum bile acids, in the absence of other hepatobiliary disease. * HDP included preeclampsia/eclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, and gestational hypertension.
adverse fetal outcomes of female CP patients
Time frame: through study completion, an average of 1 year
* Low birth weight was defined as weight at birth <2500 g. * CP-associated abortion referred to abortions (i.e., a nonviable intrauterine pregnancy up to 20 weeks' gestation) which happened due to the attack of CP or comorbidities associated with CP. * Congenital anomaly referred to the inborn errors of development. * Stillbirth was defined as the delivery of a fetus ≥20 weeks of gestation with no signs of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 38334943Wu D, Ru N, Wang YC, Ma GX, Shi TY, Xiong SH, You AJ, Wang L, Hu LH, Li ZS, Zou WB, Liao Z. Genetic Factors Associated With Adverse Pregnancy Outcomes in Chronic Pancreatitis. Clin Transl Gastroenterol. 2024 Apr 1;15(4):e00691. doi: 10.14309/ctg.0000000000000691.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
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.
Zhuan Liao principal investigator
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 Chronic Pancreatitis and Genetic Mutation, run by Changhai Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 28 Sep 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?
Results are not available in the source record.
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?
adverse maternal outcomes of female CP patients (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT06055595, 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 28 Sep 2023.