Actively Recruiting

Age: 18Years +
All Genders
NCT04874064

TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence

Led by Jewish General Hospital · Updated on 2025-11-28

130

Participants Needed

3

Research Sites

416 weeks

Total Duration

On this page

Sponsors

J

Jewish General Hospital

Lead Sponsor

E

Exactis Innovation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Triple negative breast cancer (TNBC) is the most aggressive of breast cancers and it is usually treated with chemotherapy even before surgery. In many cases, the chemotherapy completely "melts" the tumor and these patients do well. When the tumor is not eliminated by the chemotherapy, the patient receive more chemotherapy after surgery to decrease the chances of it coming back. Yet many of these patients don't need that extra chemotherapy and will do well in any case. One of the most exciting recent developments in cancer is the use of "liquid biopsies". It turns out that the tumor's DNA, RNA and proteins can be detected in small vesicles found in the patient's blood. Thanks to advances in Artificial Intelligence, there is now informatics tools to integrate many types of molecular information. Our industrial partner, MIMs, will apply novel informatics tools to generate a test using all the molecular information obtained from blood vesicles and tissue that will be able to find out early if tumor has spread outside of the breast, and how much tumor is left after surgery. The goal is hope to develop a multi-dimensional test for TNBC patients that can be used to decide how much treatment they need and if treatment given after surgery is working.

CONDITIONS

Official Title

TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Triple negative (ER negative, PR negative and Her2 negative as defined by local standards). ER <10% is acceptable.
  • Patients who have completed a minimum of 8 weeks of neoadjuvant chemotherapy.
  • A cohort of TNBC patients who are awaiting surgery that have clinical or radiological evidence of residual tumor prior to surgery. This evaluation will be made at the discretion of the treating physician.

OR A second cohort of TNBC patients will be recruited after surgery, in which pathological evaluation has demonstrated the presence of residual tumor post-surgery.

  • Patients who can come to the clinic for standard of care follow-up within 6 weeks post-surgery and in the next 6 months after surgery.
  • Patients who are willing to provide serial blood samples.
  • Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
Not Eligible

You will not qualify if you...

  • Clinical or radiological evidence of metastatic disease.
  • Patient with a recurrence of breast cancer.
  • Patients who have not had neoadjuvant chemotherapy or less than 8 weeks of neoadjuvant chemotherapy.
  • Patient who received radiotherapy treatment prior to surgery.
  • Patients who are not capable of signing or understanding the informed consent form.
  • Known infection with HIV or hepatitis.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

St. Joseph's Health Care London

London, Ontario, Canada, N6A 4V2

Actively Recruiting

2

The Ottawa Hospital Cancer Center

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

3

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E1

Actively Recruiting

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Research Team

A

Adriana Aguilar, PhD

CONTACT

J

Josiane Lafleur, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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