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NCT04874064Recruiting

TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence

Triple Negative Breast Cancer Markers in Liquid Biopsies Using Artificial Intelligence (TRICIA Study)

Source: ClinicalTrials.gov · Last updated 28 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
130 (estimated)
First submitted
30 Apr 2021
Start date
5 Dec 2019
Primary completion date
31 Dec 2027
Lead sponsor
Jewish General Hospital
NCT number
NCT04874064

What you commit to

  • Study type: Observational
  • Planned participants: 130
  • From 5 Dec 2019 to the primary completion date, 31 Dec 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have not had neoadjuvant chemotherapy or less than 8 weeks of neoadjuvant chemotherapy.
  • Patient who received radiotherapy treatment prior to surgery.

Other illness

  • Clinical or radiological evidence of metastatic disease.
  • Patient with a recurrence of breast cancer.
  • Known infection with HIV or hepatitis.

Other

  • Patients who are not capable of signing or understanding the informed consent form.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Joseph's Health Care London
Coordinator of this site? Confirm its status
LondonCanadaRecruiting
Jewish General Hospital
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
The Ottawa Hospital Cancer Center
Coordinator of this site? Confirm its status
OttawaCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.