RecruitingNCT04275557

Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas

Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

1,174 participants

Start Date

Feb 18, 2020

Study Type

OBSERVATIONAL

Conditions

Pancreatic Cancer Pancreatic Cyst

Summary

The Florida Pancreas Collaborative wants to partner with individuals who are known to have, or are suspected to have a pancreatic lesion, tumor, cyst, mass, cancer, or pancreatitis and are undergoing diagnosis and treatment at a participating institution. The goals of this project are to build a large database of information obtained from blood, tissue, medical images, surveys and information from routine care to develop noninvasive diagnostic approaches that could be used as decision-making tools to effectively personalize clinical care.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria4

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.

Interventions

OTHERBlood Sample collection

Participants will be asked to donate blood at baseline (+/- 30 days of diagnosis date), 4-6 weeks post-surgery, if applicable, and at the time of follow-up (approximately 1 year and approximately 2 years after baseline).

OTHERTissue sample collection

At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue, muscle, fat, tissue from site of metastasis, and cyst fluid (if applicable) will be collected.

OTHERData collection

Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups.