Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
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ClinicalTrials.gov Identifier: NCT03709134 |
Recruitment Status : Unknown
Verified October 2021 by Dr. Katarzyna Jerzak, Sunnybrook Health Sciences Centre.
Recruitment status was: Recruiting
First Posted : October 17, 2018
Last Update Posted : October 14, 2021
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Condition or disease | Intervention/treatment |
---|---|
Breast Cancer Breast Neoplasms Cancer, Breast | Diagnostic Test: Genomic Markers (CTC/ctDNA) |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 5 Years |
Official Title: | Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy |
Actual Study Start Date : | October 1, 2019 |
Estimated Primary Completion Date : | September 1, 2022 |
Estimated Study Completion Date : | September 1, 2022 |
- Diagnostic Test: Genomic Markers (CTC/ctDNA)
This is a non-interventional study.
- Pathologic complete response (pCR) [ Time Frame: Up to 60 months ]Evaluating the degree of absence of residual cancer cells
- Time to distant breast cancer recurrence (months) [ Time Frame: Up to 60 months ]Evaluating the time until a recurrence event has occurred in the breast.
- Time to any recurrence (months) [ Time Frame: Up to 60 months ]Evaluating the time until a local, regional, or distant recurrence event has occurred.
- Time to death [ Time Frame: Up to 60 months ]Evaluating time to cancer-related death
Biospecimen Retention: Samples With DNA
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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 |
Inclusion Criteria:
- Subjects must give appropriate written informed consent prior to participation in the study.
- Subjects must be women or men age 18+.
- Subjects must be receiving neoadjuvant chemotherapy for breast cancer. All chemotherapy types and regimens are acceptable (systemic therapy will determined by the overseeing medical oncologist).
- Biopsy-confirmed diagnosis of invasive breast cancer (i.e. ER+/-, PR+/-, HER2+/-).
- Stage I-III disease according to the AJCC v7 criteria.
Exclusion Criteria:
- Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. silicone/saline implants) involving either breast, exclusive of the lesion at issue.
- Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety.
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): NCT03709134
Contact: Katarzyna J Jerzak, MD, MSc, FRCPC | 416-480-6100 ext 5248 | katarzyna.jerzak@sunnybrook.ca | |
Contact: William T Tran, MSc, PhD, MRT(T) | 416-480-6100 ext 3746 | william.tran@sunnybrook.ca |
Canada, Ontario | |
Sunnybrook Health Sciences Centre | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Katarzyna J Jerzak, MD, MSc, FRCPC 416-480-6100 ext 5248 katarzyna.jerzak@sunnybrook.ca | |
Contact: William T Tran, MSc, PhD, MRT(T) 416-480-6100 ext 3746 william.tran@sunnybrook.ca | |
Principal Investigator: Kasia J Jerzak, MD, MSc |
Principal Investigator: | Katarzyna J Jerzak, MD, MSc, FRCPC | Sunnybrook Health Sciences Centre |
Responsible Party: | Dr. Katarzyna Jerzak, Medical Oncologist & Associate Scientist, Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT03709134 |
Other Study ID Numbers: |
178-2018 |
First Posted: | October 17, 2018 Key Record Dates |
Last Update Posted: | October 14, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Circulating tumor cells CTC Circulating tumor DNA |
ctDNA Genomics Transcriptomics |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |