Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT01722851
Brief Summary:
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.
Detailed Description:
Primary Objectives:
1. To identify a panel of miRNAs, detectable in the circulation, which are altered in breast cancer patients
2. To identify specific combinations of miRNAs ('signatures') which associate with breast cancer intrinsic subtypes, and thereby could aid in prognostication and treatment planning on an individual patient basis.
Secondary Objective:
1. To determine if systemic miRNA analysis can be used as a biomarker for monitoring response to chemotherapy, in the neoadjuvant setting and in patients who present with breast cancer recurrence and are treated with upfront chemotherapy and/or hormonal therapy.
This is a prospective cohort studies, involving three study cohorts:
Cohort 1: All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy.
Cohort 2: All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy +/- hormonal therapy.
Cohort 3: All breast cancer patients who present with metastatic disease who are commencing hormonal therapy only.
Blood Sample
Blood Sampling - Cohort 1:
\- Blood sample 1: at presentation before commencing neoadjuvant treatment.
\- Blood sample 2: midway through their chemotherapy treatment (after 2nd cycle if they are enrolled in a 4 cycle regimen, or after 4th cycle if they are prescribed an 8 week regimen).
\- Blood sample 3: post-chemotherapy (before surgery as applicable).
\- Blood sample 4: 2 to 4 weeks after surgery, or 2 to 4 weeks post 3rd blood sampling if patients do not undergo surgery.
\- Blood sample 5: once during follow-up of 12 to 18 months after surgery or 12 to 18 months post 3rd blood sampling if patients do not undergo surgery.
Blood Sampling - Cohort 2:
\- Pre-treatment blood sample: at presentation before commencing treatment.
\- On study blood samples: taken at monthly (± 1 week) intervals for a period of 6 months from date of pre-treatment blood sample, despite whether the patient is on treatment or completed treatment.
On study blood sample 1: 1 month (± 1 week) from date of pre-treatment blood sample
On study blood sample 2: 2 months (± 1 week) from date of pre- treatment blood sample
On study blood sample 3: 3 months (± 1 week) from date of pre-treatment blood sample
On study blood sample 4: 4 months (± 1 week) from date of pre-treatment blood sample
On study blood sample 5: 5 months (± 1 week) from date of pre-treatment blood sample
On study blood sample 6: 6 months (± 1 week) from date of pre-treatment blood sample
\- End of study blood sample: once during follow-up of 12 to 18 months from date of pre-treatment blood sample or at the time of disease progression.
Blood Sampling - Cohort 3:
\- Pre-treatment blood sample: at presentation before commencing treatment.
\- On study blood samples: taken at the following time points despite whether the patient is on treatment or completed treatment.
On study blood sample 1: 3 months (± 2 weeks) from date of pre-treatment blood sample On study blood sample 2: 6 months (± 2 weeks) from date of pre-treatment blood sample On study blood sample 3: 12 months (± 2 weeks) from date of pre-treatment blood sample
\- End of study blood sample: 18 months (± 2 weeks) from date of pre-treatment blood sample or at the time of disease progression.
Blood samples will be processed for miRNA analysis, which involves:
1\. Lysis using Trizol 2. RNA isolation 3. Assessing concentration and integrity of RNA using Nanodrop spectrophotometry 4. cDNA synthesis (using miRNA specific stem loop primers) 5. PCR amplification and relative quantification (using miRNA specific probes)
Study:
NCT01722851
Study Brief:
Protocol Section:
NCT01722851