MedTrace Logo

Evaluation of Clinical, Radiomics and Molecular Features of Lung Metastasis in PDAC Patients (LUMACA Trial)

NCT04435067 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2020-07-16

No results posted yet for this study

Summary

The aim of this study is the characterization from epidemiological, radiomics and molecular point of view of lung metastasis of patients at beginning affected by pancreatic adenocarcinoma (PDAC), which after the resection of primitive tumor have met with initial recurrence of the disease exclusively at the lung level.

Conditions

  • Pancreas Adenocarcinoma

Interventions

GENETIC

Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia

The mutational analysis of the main oncogenes and tumor suppressor genes involved in the genesis and tumor progression will be performed on the genomic DNA extracted from each sample using the Ion Torrent TM Oncomine TM Comprehensive Assay version 3 (OCAv3) kit. This panel includes 161 cancer-related genes and allows the identification of all genomic alterations affecting oncogenes and recurrently altered tumor suppressor genes in solid tumors. The study of gene expression will be carried out using Nanostring Technology using the Pancancer IO 360 TM panel which allows simultaneous analysis for each sample of multiple mRNAs associated with crucial pathways in carcinogenesis and the immunological profile of the tumor, defining its up and down conditions gene regulation.

OTHER

Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumor

This study will be performed using the SPAARC IBSI (International Biomarker Standardization Initiative) compliant software implemented in the MatLab environment (MathWorks, Boston, USA) through several steps: (a) CT imaging retrieval, (b) image segmentation and rendering, (c) feature extraction and (d) qualification/quantification. Approximately 200 radiomics characteristics will be extracted, such as: Morphology, Statistical, Intensity Histogram, Gray Level Co-occurrence Matrix 3D\_average, Gray Level Co-occurrence Matrix 3D\_combined, Gray Level Run Length 3D\_average, Gray Level Run Length 3D\_combined, Gray Level Size Zone Matrix 3D, Neighbor Gray Tone Difference Matrix 3D, Gray Level Distance Zone Matrix 3D.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Michele Reni, MD · IRCCSS Raffaele

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04435067 on ClinicalTrials.gov