Predicting the cancer risk of pancreatic cysts using genetic information
Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology
This study is trying to see if using genetic information can help predict the cancer risk in people with pancreatic cysts or tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1174 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Lakewood Rch, Florida and 2 other locations) |
| Trial ID | NCT04275557 on ClinicalTrials.gov |
What this trial studies
This observational study aims to partner with individuals suspected of having pancreatic lesions, tumors, or cysts to collect blood, tissue, and medical imaging data. The Florida Pancreas Collaborative seeks to build a comprehensive database that will help develop noninvasive diagnostic tools for personalizing clinical care. Participants will provide biological specimens and complete questionnaires as part of their routine care. The ultimate goal is to enhance decision-making in the management of pancreatic conditions.
Who should consider this trial
Good fit: Ideal candidates are individuals with a clinical suspicion or diagnosis of pancreatic lesions, cysts, masses, cancer, or pancreatitis who have not yet undergone treatment.
Not a fit: Patients who have already received treatment for pancreatic conditions or do not have any suspicion or diagnosis of pancreatic lesions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for assessing the malignant potential of pancreatic lesions, potentially guiding treatment decisions.
How similar studies have performed: While the approach of using radiogenomics is innovative, similar studies have shown promise in other areas of cancer diagnostics, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals who present to the GI clinic, surgery, or endoscopy at Moffitt, Florida Research Institute (FRI), or UM with a clinical suspicion for (or diagnosis of) a pancreatic lesion, cyst, mass, cancer, or pancreatitis based on symptoms, imaging, or blood-work and has not had any treatment involving their pancreas. * Able to understand and voluntarily sign the informed consent. * Willing to complete study questionnaire(s) and donate medical images and/or biological specimens (including blood, cystic fluid, and/or tissue) obtained at the time of standard of care procedures (biopsy, surgery, and venipuncture) after signing the informed consent document Exclusion Criteria: * No suspicion or diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis. * Has a diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis and has already undergone treatment involving the pancreas (which may involve surgery, chemo- or immuno-therapy, and/or radiation). * Unable to provide informed consent. * Unwilling to complete study questionnaire(s) and/or donate biological specimens or images.
Where this trial is running
Lakewood Rch, Florida and 2 other locations
- Florida Research Institute (FRI) — Lakewood Rch, Florida, United States (Recruiting)
- Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital — Miami, Florida, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Permuth, PhD — Moffitt Cancer Center
- Study coordinator: Toni Basinski, MS
- Email: Toni.Basinski@moffitt.org
- Phone: 813-745-6360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.