Recruiting

Radiogenomics

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT04275557

Conditions

Pancreatic Cancer

Pancreatic Cyst

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Sample collection

Tissue sample collection

Data collection

Study Details

Brief 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.

Conditions

Pancreatic Cancer

Pancreatic Cyst

Study ID

NCT04275557

Start date

Feb 18, 2020

Status verified date

Dec, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1174 participants

Anticipated

Interventions and Outcome Measures

Arms

Retrospective Cohort

Retrospective chart review of pathologically-confirmed Intraductal Papillary Mucinous Neoplasm (IPMN) cases

Prospective Cohort

Blood, tumor tissue samples and data will be collected.

Interventions

Blood 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).

Tissue 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.

Data collection

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

Primary outcome measure

  • Predictive value of CT Radiomic features vs conventional radiologic features [ Time Frame: Up to 2 years ]
  • Development of Clinical Decision Making Models for Predicting IPMN Pathology [ Time Frame: Up to 2 years ]
  • Radiogenomic Analyses [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Toni Basinski, MS

813-745-6360Toni.Basinski@moffitt.org

Locations

Florida Research Institute (FRI)

Recruiting

Lakewood Rch, Florida, United States, 34211

Contacts

Arun Khazanchi, MD

941-727-7772arun.khazanchi@fdhs.com

Principal Investigator:

Arun Khazanchi, MD

Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital

Recruiting

Miami, Florida, United States, 33136

Contacts

Nipun B Merchant, MD, FACS

305-243-7160nmerchant@miami.edu

Principal Investigator:

Nipun B Merchant, MD, FACS

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Toni Basinski, MS

813-745-6360Toni.Basinski@moffitt.org

Principal Investigator:

Jennifer B Permuth, PhD, MS

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Keywords

  • Pancreatic Lesions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2025-12-04.