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

NCT04435067 | Unknown

• 1 other identifier: PACT32
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Pancreas Adenocarcinoma; Lung Metastasis; Gene Expression; Molecular analysis; Radiomics

Outcome Measures

Primary Outcomes (1)

• Clinical and pathological features of lung metastasis

  Analyze the clinical and pathological characteristics of the two cohorts of patients affected by lung metastasis from PDAC

  6 months

Secondary Outcomes (2)

• Molecular and radiomics features of lung metastasis

  18 months

• Differences between the two cohorts

  18 months

Study Arms (2)

Cohort A

patients in whom lung metastasis were resected for therapeutic purposes

Genetic: Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia; Other: Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumor

Cohort B

patients in whom lung metastasis were removed for diagnostic purposes only

Genetic: Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia; Other: Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumor

Interventions

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

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.

Cohort A; Cohort B

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

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.

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a confirmed diagnosis of lung metastasis from PDAC from 2008 to 2019

You may qualify if:

• Cytological/histological diagnosis of pancreatic adenocarcinoma as a primary tumor and localization of adenocarcinoma compatible with pancreatic primitivity for lung metastasis;
• Previous surgical resection of the primary tumor;
• Exclusive presence of single or multiple lung metastasis at disease recurrence;
• Radical or diagnostic excision of lung metastasis;
• Informed patient consent (for currently living patients).

You may not qualify if:

• Patients not undergoing lung resection surgery for diagnostic and/or therapeutic purposes for cardiac or respiratory functional contraindication.
• Patients with lung metastases synchronous with primary cancer. Contacts and Locations

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (4)

IRCCS San Raffaele Diagnostic Radiology Unit

Milan, 20132, Italy

RECRUITING

IRCCS San Raffaele Medical Oncology Unit

Milan, 20132, Italy

RECRUITING

IRCCS San Raffaele Pathological Anatomy Unit

Milan, 20132, Italy

RECRUITING

IRCCS San Raffaele Thoracic Surgery Unit

Milan, 20132, Italy

RECRUITING

Related Publications (5)

• Arnaoutakis GJ, Rangachari D, Laheru DA, Iacobuzio-Donahue CA, Hruban RH, Herman JM, Edil BH, Pawlik TM, Schulick RD, Cameron JL, Meneshian A, Yang SC, Wolfgang CL. Pulmonary resection for isolated pancreatic adenocarcinoma metastasis: an analysis of outcomes and survival. J Gastrointest Surg. 2011 Sep;15(9):1611-7. doi: 10.1007/s11605-011-1605-8. Epub 2011 Jul 2.

  PMID: 21725701 BACKGROUND

• Ceppa DP. Results of Pulmonary Resection: Sarcoma and Germ Cell Tumors. Thorac Surg Clin. 2016 Feb;26(1):49-54. doi: 10.1016/j.thorsurg.2015.09.007.

  PMID: 26611510 BACKGROUND

• Okui M, Yamamichi T, Asakawa A, Harada M, Horio H. Resection for Pancreatic Cancer Lung Metastases. Korean J Thorac Cardiovasc Surg. 2017 Oct;50(5):326-328. doi: 10.5090/kjtcs.2017.50.5.326. Epub 2017 Oct 5.

  PMID: 29124023 BACKGROUND

• Rama N, Monteiro A, Bernardo JE, Eugenio L, Antunes MJ. Lung metastases from colorectal cancer: surgical resection and prognostic factors. Eur J Cardiothorac Surg. 2009 Mar;35(3):444-9. doi: 10.1016/j.ejcts.2008.10.047. Epub 2009 Jan 10.

  PMID: 19136273 BACKGROUND

• Yamashita K, Miyamoto A, Hama N, Asaoka T, Maeda S, Omiya H, Takami K, Doki Y, Mori M, Nakamori S. Survival Impact of Pulmonary Metastasis as Recurrence of Pancreatic Ductal Adenocarcinoma. Dig Surg. 2015;32(6):464-71. doi: 10.1159/000439545. Epub 2015 Oct 31.

  PMID: 26517228 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA from histological samples fixed in formalin and included in paraffin

Study Officials

• Michele Reni, MD

  IRCCSS Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Orsi, MD

CONTACT

+390226437602; orsi.giulia@hsr.it

Maria Maddalena Valente, PhD

CONTACT

+390226437623; valente.mariamaddalena@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 17, 2020
• Study Start: May 27, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)