NCT06651580 Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study
| NCT ID | NCT06651580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Chronic Pancreatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,600 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2027-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,600 participants in total. It began in 2021-04-01 with a primary completion date of 2027-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.
Eligibility Criteria
Inclusion Criteria: * 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 * 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) Exclusion Criteria: * 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
Contact & Investigator
Ying Yuan, PHD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06651580 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Chronic Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06651580 currently recruiting?
Yes, NCT06651580 is actively recruiting participants. Contact the research team at yyuan@mdanderson.org for enrollment information.
Where is the NCT06651580 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States, Oakland, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT06651580 clinical trial?
NCT06651580 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Ying Yuan, PHD at M.D. Anderson Cancer Center. The trial plans to enroll 1,600 participants.