Chronic PancreatitisNCT06651580
Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study
An observational study of Chronic Pancreatitis and Exocrine Pancreas Carcinoma, run by M.D. Anderson Cancer Center at 26 sites in 4 countries.
Trial summary
This clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Chronic Pancreatitis, Exocrine Pancreas Carcinoma, Recurrent Acute Pancreatitis
- What is being tested?
- Biospecimen Collection, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 1,600 participants
- Where
- 26 sitesin 4 countries
- Study dates
- 1 Apr 2021to 2 Feb 2027
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients (under 18 years) enrolled in the INSPPIRE 1 database who are planned to be reenrolled under this protocol over the next 4 years.
Who may be able to join
- All subjects/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study
- Subjects/parents must have signed an authorization for the release of their or their child's protected health information
- All children must be under 18 years of age at the time of enrollment
- All children providing samples should fit the ARP or CP inclusion criteria defined below:
- Acute pancreatitis (AP): AP is defined as requiring 2 of the following:
- Abdominal pain compatible with AP
Show all 17Show fewer
- Serum amylase and/or lipase values >= 3 times upper limits of normal
- Imaging findings of AP, such as gland enlargement, acute inflammatory changes, and fluid collections
- ARP is defined as: At least 2 episodes of acute pancreatitis with complete resolution of pain and a >= 1 month pain-free interval between episodes
- Chronic Pancreatitis:
- Children with at least:
- One irreversible structural change in the pancreas with or without abdominal pain +/- exocrine pancreatic insufficiency +/- diabetes
- Irreversible structural changes:
- Ductal calculi, dilated side branches, parenchymal calcifications found in any imaging (abdominal ultrasound [abd US], magnetic resonance imaging/magnetic resonance cholangiopancreatography [MRI/MRCP], computerized tomography [CT], endoscopic retrograde cholangiopancreatography [ERCP], endoscopic US [EUS])
- Ductal obstruction or stricture/dilatation/irregularities that are persistent (for >= 2 months) on any imaging
- Parenchymal atrophy, irregular contour, accentuated lobular architecture, cavities alone are not diagnostic findings for CP
- Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages)
Who cannot join
- Subjects must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the subject's ability to tolerate study interventions
Trial locations and contacts
26 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 4 countries
United States22 sites, 22 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Reuven Cohen, MD, 404-785-5437, reuven.zev.cohen@emory.edu
Reuven "Zev" Cohen
- Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Kenneth Ng, 516-906-1716, kng13@jhmi.edu
Kenneth Ng
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Amit Grover, 617-619-4713, amit.grover@childrens.harvard.edu
Amit Grover
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Maisam Abu-El-Haija, 513-803-2123, Maisam.Haija@cchmc.org
Maisam Abu-El-Haija
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Cheryl Gariepy, 614-722-8406, Cheryl.Gariepy@nationwidechildrens.org
Cheryl Gariepy
- Recruiting
University of Texas Southwestern/Children's Medical Center
Dallas, Texas, 75235
Megha Mehta, MD, 972-979-2154, megha.mehta@utsouthwestern.edu
Megha Mehta
- Recruiting
University of Colorado
Denver, Colorado, 80217-3364
Jacob Mark, 720-777-6669, jacob.mark@childrenscolorado.org
Jacob Mark
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Suresh T. Chari, 713-501-3714, STChari@mdanderson.org
Suresh T. Chari
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Douglas Fishman, douglas.fishman@bcm.edu
Douglas Fishman
- Recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
Brian McFerron, 317-944-3774, bmcferro@iu.edu
Brian McFerron
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Aliye Uc, 319-384-6032, aliye-uc@uiowa.edu
Aliye Uc
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Yuhua Zheng, 323-361-4454, yzheng@chla.usc.edu
Yuhua Zheng
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Quin Liu, 310-423-6082, quin.liu@cshs.org
Quin Liu
- Recruiting
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Ankur Chugh, MD, 414-266-4843, achugh@mcw.edu
Ankur Chugh
- Recruiting
University of Minnesota/Masonic Children's Hospital
Minneapolis, Minnesota, 55454
Elissa Downs, MD, 612-624-1133, down@0015@umn.edu
Elissa Downs
- Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Matthew Giefer, MD, 504-842-4021, matthew.giefer@ochsner.org
Matthew Giefer
- Recruiting
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
Emily Perito, 415-476-5892, emily.perito@ucsf.edu
Emily Perito
- Recruiting
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
Zachary Sellers, 650-497-8000, zsellers@stanford.edu
Zachary Sellers
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Asim Maqbool, 215-590-3247, MAQBOOL@email.chop.edu
Asim Maqbool
- Recruiting
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Douglas Lindblad, 412-946-2053, lindbladd@upmc.edu
Douglas Lindblad
- Recruiting
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Adam Noel, 205-704-4515
Adam Noel
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Mark Lowe, 314-286-2784, lowe@wustl.edu
Mark Lowe
Canada2 sites, 2 recruiting
- Recruiting
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
Veronique Morinville, 514-412-4400 ext. 23345, veronique.morinville@mcgill.ca
Veronique Morinville
- Recruiting
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Tanja Gonska, 416-813-2164, tanja.gonska@sickkids.ca
Tanja Gonska
Australia1 site, 1 recruiting
- Recruiting
Sydney Children's Hospital
Randwick, New South Wales, 2031
Keith Ooi, keith.ooi@hongyee.org
Keith Ooi
Israel1 site, 1 recruiting
- Recruiting
Hadassah University Hospital
Jerusalem, 91120
Michael Wilschanski, michaelwil@hadassah.org.il
Michael Wilschanski
About this study
Official title: Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)
This clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To comprehensively characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) and determine predictors of early onset CP and its sequelae.
OUTLINE:
Patients complete quality-of-life (QoL) assessment and complete questionnaires for over 2 hours every 12 months for 4 years. Patients also undergo collection of blood and/or saliva (if blood samples are not available), urine, or stool at baseline or follow-up (if inadequate samples collected or missed at baseline).
After completion of the study, patients are followed up every 12 months.
- Being tested
- Biospecimen Collection, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Pancreatitis, Chronic, Pancreatic Neoplasms, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood, saliva, urine or stool samples
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete QoL assessment
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Observational (biospecimen collection and questionnaire) | Patients complete QoL assessment and complete questionnaires for over 2 hours every 12 months for 4 years. Patients also undergo collection of blood and/or saliva (if blood samples are not available), urine, or stool at baseline. Receives: Procedure: Biospecimen Collection; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP)
Two-sample t-test or Wilcoxon rank-sum test will be used for the continuous/ordinal variables and Pearson Chi-square test for the categorical variables. The variables that suggest differences between ARP and CP (p value < 0.15) will be included as independent variables in a multivariable logistic regression analysis for CP progression.
Measured: Up to 4 years
Risk factors that predispose children to CP sequelae and high disease burden
A two-sample t-test or Wilcoxon rank-sum test for the continuous/ordinal variables and Pearson Chi-square test for the categorical variables. The variables that suggest an association with sequelae/disease burden (p-value < 0.15) will be included as independent variables in a regression model for sequelae/disease burden. Normal/logistic/multinomial regression model will be used for continuous/binary/ordinal disease burden and sequelae outcomes. For repeated measures, random effects will be added to these models to account for correlation among the measures.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Apr 2021
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ying Yuan, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651580
- Sponsor's protocol ID
- 2020-1057
- Other IDs
- NCI-2021-04028, 2020-1057, P30CA016672
- Status last verified
- Sep 2026
- First submitted
- 18 Oct 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)
- ClinicalTrials.gov ID
- NCT06651580
- Acronym / sponsor ID
- 2020-1057
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 21 Oct 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.
This clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.
Detailed description
PRIMARY OBJECTIVE:
- To comprehensively characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) and determine predictors of early onset CP and its sequelae.
OUTLINE:
Patients complete quality-of-life (QoL) assessment and complete questionnaires for over 2 hours every 12 months for 4 years. Patients also undergo collection of blood and/or saliva (if blood samples are not available), urine, or stool at baseline or follow-up (if inadequate samples collected or missed at baseline).
After completion of the study, patients are followed up every 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (biospecimen collection and questionnaire) | – | Procedure: Biospecimen Collection, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients complete QoL assessment and complete questionnaires for over 2 hours every 12 months for 4 years. Patients also undergo collection of blood and/or saliva (if blood samples are not available), urine, or stool at baseline. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients (under 18 years) enrolled in the INSPPIRE 1 database who are planned to be reenrolled under this protocol over the next 4 years.
Key inclusion criteria (17 listed)
- All subjects/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study
- Subjects/parents must have signed an authorization for the release of their or their child's protected health information
- All children must be under 18 years of age at the time of enrollment
- All children providing samples should fit the ARP or CP inclusion criteria defined below:
Key exclusion criteria (1 listed)
- Subjects must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the subject's ability to tolerate study interventions
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood, saliva, urine or stool samples | Procedure or surgery | Observational (biospecimen collection and questionnaire) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete QoL assessment | Other | Observational (biospecimen collection and questionnaire) |
| Questionnaire AdministrationComplete questionnaire | Other | Observational (biospecimen collection and questionnaire) |
Primary outcome
Characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP)
Time frame: Up to 4 years
Two-sample t-test or Wilcoxon rank-sum test will be used for the continuous/ordinal variables and Pearson Chi-square test for the categorical variables. The variables that suggest differences between ARP and CP (p value < 0.15) will be included as independent variables in a multivariable logistic regression analysis for CP progression.
Risk factors that predispose children to CP sequelae and high disease burden
Time frame: Up to 4 years
A two-sample t-test or Wilcoxon rank-sum test for the continuous/ordinal variables and Pearson Chi-square test for the categorical variables. The variables that suggest an association with sequelae/disease burden (p-value < 0.15) will be included as independent variables in a regression model for sequelae/disease burden. Normal/logistic/multinomial regression model will be used for continuous/binary/ordinal disease burden and sequelae outcomes. For repeated measures, random effects will be added to these models to account for correlation among the measures.
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 11 Sep 2026.
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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.
Ying Yuan, PHD principal investigator
M.D. Anderson Cancer Center
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Exocrine Pancreas Carcinoma, run by M.D. Anderson Cancer Center at 26 sites in 4 countries.
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 17 inclusion and 1 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada, Australia, Israel. 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 Ying Yuan, PHD ((713) 563-4271, yyuan@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) (time frame: Up to 4 years). 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?
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 11 Sep 2026.