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

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04275557
Collaborator
National Cancer Institute (NCI) (NIH), University of Florida (Other), University of Miami (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood Sample collection
  • Other: Tissue sample collection
  • Other: Data collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
1174 participants
Observational Model:
Case-Only
Time Perspective:
Other
Official Title:
Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology
Actual Study Start Date :
Feb 18, 2020
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2027

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Predictive value of CT Radiomic features vs conventional radiologic features [Up to 2 years]

    Preoperative CT images will be evaluated for a retrospective cohort of at least 254 pathologically-confirmed IPMN cases (approximately 190 malignant characterized by high-grade dysplasia or invasion and approximately 64 benign characterized by low- or moderate-grade dysplasia). 3D-radiomic features will be extracted with the new Quantitative Imaging Decision Support (QIDS)™ platform (Healthmyne, Inc.) and associations will be evaluated with pathology.

  2. Development of Clinical Decision Making Models for Predicting IPMN Pathology [Up to 2 years]

    Investigators will develop the first prototype preoperative 'omics'-based nomograms to predict IPMN pathology by integrating radiomic features, the MGC, and other covariates. Emphasis will be placed on developing nomograms for individuals whose IPMNs appear to have 'worrisome' radiologic features which are very challenging to manage.

  3. Radiogenomic Analyses [Up to 2 years]

    Investigators will conduct the first radiogenomic analyses of IPMNs by evaluating the relationship between radiomic features and tissue and circulating levels of candidate biomarkers.

Secondary Outcome Measures

  1. Overall Survival [Up to 4 years]

    Overall survival is defined as time from surgery to death from any cause.

  2. Progression Free Survival [Up to 4 years]

    Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Florida Research Institute (FRI) Lakewood Ranch Florida United States 34211
2 Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital Miami Florida United States 33136
3 Moffitt Cancer Center Tampa Florida United States 33612

Sponsors and Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute
  • National Cancer Institute (NCI)
  • University of Florida
  • University of Miami

Investigators

  • Principal Investigator: Jennifer Permuth, PhD, Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT04275557
Other Study ID Numbers:
  • MCC-20105
  • 1R37CA229810-01A1
First Posted:
Feb 19, 2020
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022