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

Pancreatic Cancer Clinical Trial

Official title:

Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275557
• Other study ID #: MCC-20105
• Secondary ID: 1R37CA229810-01A
• Status: Recruiting
• Start date: February 18, 2020
• Est. completion date: June 2027

Study information

• Verified date: June 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Toni Basinski, MS
• Phone: 813-745-6360
• Email: Toni.Basinski[@]moffitt.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1174
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Neoplasms, Cystic, Mucinous, and Serous
• 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).
• 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.

Locations

Country	Name	City	State
United States	Florida Research Institute (FRI)	Lakewood Ranch	Florida
United States	Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital	Miami	Florida
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (4)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI), University of Florida, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value of CT Radiomic features vs conventional radiologic features	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.	Up to 2 years
Primary	Development of Clinical Decision Making Models for Predicting IPMN Pathology	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.	Up to 2 years
Primary	Radiogenomic Analyses	Investigators will conduct the first radiogenomic analyses of IPMNs by evaluating the relationship between radiomic features and tissue and circulating levels of candidate biomarkers.	Up to 2 years
Secondary	Overall Survival	Overall survival is defined as time from surgery to death from any cause.	Up to 4 years
Secondary	Progression Free Survival	Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death.	Up to 4 years

External Links

•   Moffitt Cancer Center website