NCT03402997

Brief Summary

The resistivity measurements will be done by introducing a needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

1.8 years

First QC Date

January 11, 2018

Last Update Submit

December 11, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Breat tissue characterization

    Use of Electrical Impedance Spectroscopyuse (EIS) to characterize ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues

    30 minutes from surgery

Secondary Outcomes (2)

  • Evaluation of the precision of each EIS measurement

    30 minutes from surgery

  • Correlation between electrical and biological results

    30 minutes from surgery

Study Arms (1)

Resistivity measurements

The resistivity measurements will be done by introducing the needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues

Diagnostic Test: Resistivity measurement

Interventions

Resistivity measurementDIAGNOSTIC_TEST

To measure and compare the tissue impedance values obtained by analysing ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues

Resistivity measurements

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The target population of this study are female patients with first radiological diagnosis of breast cancer needing for surgery and subsequent histological examination to confirm the diagnosis.

You may qualify if:

  • Age \>18 years
  • First radiological diagnosis of breast adenocarcinoma needing a histological confirmation
  • Written Informed Consent

You may not qualify if:

  • Tumor mass diameter \< 1 cm
  • Surgical specimen (harbouring tumoral + peritumoral tissue) diameter \< 2 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regionale di Mendrisio

Mendrisio, 6850, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

December 15, 2017

Primary Completion

September 25, 2019

Study Completion

September 25, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Locations

CH(1)