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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Other: 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).
  • Other: 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.
  • Other: Data collection
    Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups.

Recruiting Locations

Florida Research Institute (FRI)
Lakewood Rch 7255365, Florida 4155751 34211
Contact:
Arun Khazanchi, MD
941-727-7772
arun.khazanchi@fdhs.com

Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
Miami 4164138, Florida 4155751 33136
Contact:
Nipun B Merchant, MD, FACS
305-243-7160
nmerchant@miami.edu

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
Contact:
Toni Basinski, MS
813-745-6360
Toni.Basinski@moffitt.org

More Details

NCT ID
NCT04275557
Status
Recruiting
Sponsor
H. Lee Moffitt Cancer Center and Research Institute

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center