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TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence (TRICIA)

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ClinicalTrials.gov Identifier: NCT04874064
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : May 7, 2021
Sponsor:
Collaborator:
Exactis Innovation
Information provided by (Responsible Party):
Mark Basik, Jewish General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer Other: Liquid Biopsy

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Triple Negative Breast Cancer Markers in Liquid Biopsies Using Artificial Intelligence (TRICIA Study)
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Liquid Biopsy
    Blood collection and access to residual tumor.


Primary Outcome Measures :
  1. Develop signatures of good and poor outcome as well of tumor response to chemotherapy in TNBCs by integrating multidimensional profiling of both tumor and liquid biopsies making use of Artificial Intelligence (AI) tools [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Tissue and blood sample DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will be conducted in patients with a diagnosis of breast cancer and pathologically identified as triple negative (not expressing estrogen receptor (ER), progesterone receptor (PR) and HER2 protein, and not showing ERBB2 gene amplification) who will be undergoing neoadjuvant treatment and has residual tumor.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874064


Contacts
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Contact: Adriana Aguilar, PhD 514-340-8222 ext 23365 nanaaguilar@gmail.com
Contact: Josiane Lafleur, MSc 514-340-8222 ext 23365 josiane.lafleur.jgh@gmail.com

Locations
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Canada, Ontario
St. Joseph's Health Care London Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Kalan S. Lynn, MSc    519-646-6100 ext 61384    kalan.lynn@lhsc.on.ca   
Sub-Investigator: Muriel Brackstone, Dr         
The Ottawa Hospital Cancer Center Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Nathalie Tremblay    613-737-7700 ext 77265    natremblay@ohri.ca   
Sub-Investigator: Terry Ng, Dr         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Donna Morgan    416-480-6100 ext 6921    donna.morgan1@sunnybrook.ca   
Sub-Investigator: Rossanna Pezo, Dr         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E1
Contact: Josiane Lafleur    514-340-8222 ext 23365    josiane.lafleur.jgh@gmail.com   
Principal Investigator: Mark Basik, Dr         
Sponsors and Collaborators
Jewish General Hospital
Exactis Innovation
Investigators
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Principal Investigator: Mark Basik, Dr Study Principal Investigator
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Responsible Party: Mark Basik, Breast Surgeon, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT04874064    
Other Study ID Numbers: TRICIA
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark Basik, Jewish General Hospital:
Breast Cancer
Liquid Biopsy
Artificial Intelligence
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases