NCT04874064 TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence
| NCT ID | NCT04874064 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jewish General Hospital |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2019-12-05 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2019-12-05 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Mark Basik, Dr
PRINCIPAL INVESTIGATOR
Study Principal Investigator
Frequently Asked Questions
Who can join the NCT04874064 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04874064 currently recruiting?
Yes, NCT04874064 is actively recruiting participants. Contact the research team at nanaaguilar@gmail.com for enrollment information.
Where is the NCT04874064 trial being conducted?
This trial is being conducted at London, Canada, Ottawa, Canada, Montreal, Canada.
Who is sponsoring the NCT04874064 clinical trial?
NCT04874064 is sponsored by Jewish General Hospital. The principal investigator is Mark Basik, Dr at Study Principal Investigator. The trial plans to enroll 130 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.