Clinical trial · Observational
Circulating miRNAs.
Novel Breast Cancer Biomarkers and Their Use for Guiding and Monitoring Response to Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To identify a panel of circulating miRNA markers which could help identify those breast cancer patients who are most likely to respond well to neoadjuvant and adjuvant chemotherapy, and indeed serve as an overall prognostic factor and stratify patients into risk categories which would further guide their management. Similarly, the investigators aim to identify a panel of circulating miRNA markers which could monitor patient's response to chemotherapy and hormonal therapies. Ideally a suitable panel of markers would show significant changes in expression level in good-responders whilst little or no change would be observed in miRNA expression in non-responders.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Newly Diagnosed Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Cohort 1
- description
- All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy
- label
- Cohort 2
- description
- All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy ± hormonal therapy
- label
- Cohort 3
- description
- All breast cancer patient who present with metastatic disease who are commencing hormonal therapy only.
Primary outcomes (2)
- measure
- Relationship between changes in a patients circulating miRNA expression levels over the course of their systemic therapy, and their response to that treatment.
- timeFrame
- Up to week 66-92
- description
- For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses. For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1." For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses. For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1."
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Patient must meet the criteria for either: Cohort 1: All patients with a new diagnosis of breast cancer, who are destined to undergo neoadjuvant chemotherapy. OR Cohort 2: All breast cancer patients who present with metastatic disease, disease recurrence or progression who will receive up-front chemotherapy ± hormonal therapy. OR Cohort 3: All breast cancer patient who present with metastatic disease who are commencing hormonal therapy only. 2. Patients must be aged 18 years or over. 3. Patients must be able to give written informed consent. Exclusion Criteria All patients, who do not fulfil the inclusion criteria mentioned above.
References
Publications (2)
- DERIVEDDavey MG, McGuire A, Casey MC, Waldron RM, Paganga M, Holian E, Newell J, Heneghan HM, McDermott AM, Keane MM, Lowery AJ, Miller N, Kerin MJ. Evaluating the Role of Circulating MicroRNAs in Predicting Long-Term Survival Outcomes in Breast Cancer: A Prospective, Multicenter Clinical Trial. J Am Coll Surg. 2023 Feb 1;236(2):317-327. doi: 10.1097/XCS.0000000000000465. Epub 2022 Nov 2. PMID 36648259
- DERIVEDDavey MG, Casey MC, McGuire A, Waldron RM, Paganga M, Holian E, Newell J, Heneghan HM, McDermott AM, Keane MM, Lowery AJ, Miller N, Kerin MJ. Evaluating the Role of Circulating MicroRNAs to Aid Therapeutic Decision Making for Neoadjuvant Chemotherapy in Breast Cancer: A Prospective, Multicenter Clinical Trial. Ann Surg. 2022 Nov 1;276(5):905-912. doi: 10.1097/SLA.0000000000005613. Epub 2022 Jul 25. PMID 35876391