Identification of Breast Cancer Specific Markers in Patients Compared to Healthy Participants

March 8, 2023 updated by: Tethis S.p.A.

Identification and Characterization of Commercial RUO Antibodies for the Detection of Specific Breast Cancer Tumoral Markers Expressed in Potential Circulating Tumoral Cells (CTCs)

This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of breast cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors.

Study Overview

Status

Recruiting

Conditions

Detailed Description

In this research study different commercial RUO (Research Use Only) antibodies will be purchased and then tested on blood samples obtained by participants affected by breast cancer and by healthy participants as control. Sixty participants will be enrolled belonging to different categories: 20 participants affected by early breast cancer, 20 participants affected by metastatic breast cancer, and 20 healthy volunteers to be used as negative control.

After signing the informed consent form, participants will be screened to evaluate if they meet the eligibility criteria. If all the criteria are met, participants will be enrolled into the study and will be asked to provide some demographic and other data. A 13 ml blood sample will be collected by the subjects and shipped to Tethis laboratories in order to be processed and analysed.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milano, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Principal Investigator:
          • Oreste D Gentilini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Participants will be selected from among the people who visit the Breast Surgery department

Description

Inclusion Criteria:

  • Participant is willing and able to give and sign a written informed consent for participation in the study.
  • Female aged 18 years or above.
  • Diagnosed with early breast cancer (stage I and II) or metastatic breast cancer.
  • Healthy participants who visit the site for reason other than cancer diagnosis (including breast cancer).

Exclusion Criteria:

  • History of other malignancies other than breast cancer (for healthy participants includes also breast cancer).
  • Undergone surgery or treatment for breast cancer before enrollment (only for early breast cancer).
  • Presence of known severe coagulation or haematological disorder
  • Known Pregnancy
  • Absence of written signed informed consent for participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Early Breast Cancer patients
Early stage breast cancer category is based on the definition of the European Society of medical Oncology and is defined as disease confined to the breast with or without regional lymph node involvement
Metastatic Breast Cancer patients
Metastatic breast cancer category is based on the definition of the European Society of Medical Oncology and is defined as disease spread to other parts of the body, such as bones, liver or lungs (also called stage IV). Tumours at distant sites are called metastases.
Healthy donors
Participants who are in good health and without history of cancer disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of commercial Antibodies capable of Identify specific Breast Cancer Biomarkers
Time Frame: 1 day (at the blood draw)
Qualitative Assessment of Staining Positivity for different Breast Cancer Biomarkers
1 day (at the blood draw)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tethis S.p.A.

Investigators

  • Principal Investigator: Oreste Gentilini, MD, Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TET-21-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a basic research study without an IPD information sharing plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe