Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04275557
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : June 3, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Florida
University of Miami
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Tracking Information
First Submitted Date February 17, 2020
First Posted Date February 19, 2020
Last Update Posted Date June 3, 2021
Actual Study Start Date February 18, 2020
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2020)
  • Predictive value of CT Radiomic features vs conventional radiologic features [ Time Frame: 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.
  • Development of Clinical Decision Making Models for Predicting IPMN Pathology [ Time Frame: 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.
  • Radiogenomic Analyses [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 18, 2020)
  • Overall Survival [ Time Frame: Up to 4 years ]
    Overall survival is defined as time from surgery to death from any cause.
  • Progression Free Survival [ Time Frame: Up to 4 years ]
    Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas
Official Title Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole Blood, Plasma, Serum, Tumor tissue from biopsy or surgery, Muscle and fat tissue from surgery, cyst fluid, cytology supernatant, peripheral blood monocular cells (PMBCs)
Sampling Method Non-Probability Sample
Study Population Patients of the GI clinic, surgery, or endoscopy at Moffitt Cancer Center, University of Florida - Gainesville, or the University of Miami - Jackson Memorial Hospital.
Condition
  • Pancreatic Cancer
  • Pancreatic Cyst
Intervention
  • 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.
Study Groups/Cohorts
  • 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:
    • Other: Blood Sample collection
    • Other: Tissue sample collection
    • Other: Data collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 18, 2020)
1174
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2027
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Individuals who present to the GI clinic, surgery, or endoscopy at Moffitt, UF, 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 biological specimens (including blood, cystic fluid, and 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Karla Ali, MPH 813-745-1060 Karla.Ali@moffitt.org
Contact: Kaleena Dezsi, PhD 813-745-6612 Kaleena.Dezsi@moffitt.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04275557
Other Study ID Numbers MCC-20105
1R37CA229810-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators
  • National Cancer Institute (NCI)
  • University of Florida
  • University of Miami
Investigators
Principal Investigator: Jennifer Permuth, PhD Moffitt Cancer Center
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date May 2021