Investigation of Cancer Cell Extravasation Through mRNA Analysis of Organ-specific Endothelial Cells and Microfluidics

NCT04047459 | Completed

• 1 other identifier: BRCP USA
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The project aims at unraveling the role of organ-specific endothelia mediating the preferential metastasisation of breast cancer cells to bone by using a multi-faceted approach, integrating microfluidics and transcriptomic profiling. Based on a recently study published by the investigators \[Jeon et al., PNAS 2015\], it can be hypothesized that phenotypic differences at the level of organ-specific endothelial cells are able to drive the preferential extravasation of breast cancer cells to specific sites. Hence, the transcriptional profile of primary organ-specific endothelial cells derived from healthy patients (i.e. non-affected by breast cancer) will be analyzed to identify phenotypic differences between organ-specific populations of endothelial cells. These analyses will allow to identify potential target genes involved in the organ-specific extravasation of cancer cells (i.e. genes differentially expressed by endothelia of preferential and non-preferential metastasisation sites). The selected genes will be silenced and the effect of gene silencing will be evaluated through microfluidic in vitro organ-specific 3D models designed to study cancer cell extravasation.

Conditions

Breast Cancer Metastatic

Keywords

Organ specific endothelium; Microfluidics; Cancer cell extravasation

Outcome Measures

Primary Outcomes (1)

• Genes differentially expressed by bone and muscle ECs

  Differential expression of genes will be determined by transcriptomic analysis of mRNA (with genome-wide mRNA array tools) derived from bone and muscle ECs

  31/05/2018

Secondary Outcomes (4)

• Differences in adhesive properties of bone and muscle ECs

  31/05/2018

• Differences in cell adhesion between bone and muscle ECs

  31/05/2018

• Differences in angiogenic potential between bone and muscle ECs

  31/05/2018

• Selection of potential target genes involved in breast cancer metastasis

  31/05/2018

Study Arms (1)

Patient undergoing prosthetic surgery

Patients undergoing surgery for the insertion of a hip prosthesis or a cruciate ligament reconstruction will be included. On those patients tissue samples collection and cells isolation will be performed

Other: Tissue samples collection and cells isolation

Interventions

Tissue samples collection and cells isolation OTHER

During surgery, leftover samples of bone (femoral head/ trabecular bone tissue) and muscle will be collected. Then they will be sent to the laboratory where isolation of cells will be performed.

Patient undergoing prosthetic surgery

Eligibility Criteria

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

Study Population

Patients undergoing hip or knee surgery, from whom samples of waste bone and muscle tissues can be harvested.

You may qualify if:

• age between 18-65 years
• patients undergoing cruciate ligament surgery or hip arthroplasty
• subscription of informed consent

You may not qualify if:

• \- HIV, HCV, HBV, TPHA viral

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Galeazzi Orthopedic Hospital

Milan, 20161, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of bone and muscle tissue

MeSH Terms

Interventions

Cell Separation

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Matteo Moretti, PhD

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: August 6, 2019
• Study Start: June 6, 2016
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: August 6, 2019

Record last verified: 2019-08

Locations

IT (1)