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

Part of paid clinical trials in Lakewood Rch, Florida.

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

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood Sample collection — OTHER
    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 — OTHER
    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 — OTHER
    Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups.

Study Details

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.

Key Dates

Start date
Feb 18, 2020
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
1,174 participants (estimated)

Arms

  • Arm: Retrospective Cohort
    Retrospective chart review of pathologically-confirmed Intraductal Papillary Mucinous Neoplasm (IPMN) cases
  • Arm: Prospective Cohort
    Blood, tumor tissue samples and data will be collected.

Primary Outcome Measure

Predictive value of CT Radiomic features vs conventional radiologic features [ Time Frame: Up to 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Florida Research Institute (FRI)Lakewood RchFlorida34211
Arun Khazanchi, MD
941-727-7772
Arun Khazanchi, MD (PRINCIPAL_INVESTIGATOR)
Sylvester Comprehensive Cancer Center & Jackson Memorial HospitalMiamiFlorida33136
Nipun B Merchant, MD, FACS
305-243-7160
Nipun B Merchant, MD, FACS (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Toni Basinski, MS
813-745-6360
Jennifer B Permuth, PhD, MS (PRINCIPAL_INVESTIGATOR)
Daniel Jeong, MD (PRINCIPAL_INVESTIGATOR)

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