Circulating miRNAs. ICORG 10-11, V2
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|ClinicalTrials.gov Identifier: NCT01722851|
Recruitment Status : Recruiting
First Posted : November 7, 2012
Last Update Posted : October 9, 2018
|Condition or disease|
|Breast Cancer Newly Diagnosed Breast Cancer Recurrent Breast Cancer|
- To identify a panel of miRNAs, detectable in the circulation, which are altered in breast cancer patients
- 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.
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
This is a prospective cohort studies, involving two study cohorts:
Cohort 1: Newly diagnosed breast cancer patients, Cohort 2: Recurrent breast cancer patients
- 1st (baseline) blood sample at presentation before commencing neoadjuvant (cohort 1) or systemic (cohort 2) treatment.
- 2nd blood sample 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).
- 3rd blood sample post-chemotherapy and before surgery (if applicable).
- 4th blood sample 2-4 weeks after surgery, or after last blood sampling if surgery is not envisaged
- 5th blood sample 12-18 month after surgery or after 3rd blood sampling if surgery is not envisaged.
GUH only: Tissue samples will be taken at time of biopsy and/or at time of surgery.
All samples will be processed for miRNA quantification - a panel of 9 cancer-specific miRNAs will be measured in each sample, and the change in each patient's miRNA expression levels monitored over the course of their treatment.
Blood samples will be processed for miRNA analysis, which involves:
- Lysis using Trizol
- RNA isolation
- Assessing concentration and integrity of RNA using Nanodrop spectrophotometry
- cDNA synthesis (using miRNA specific stem loop primers)
- PCR amplification and relative quantification (using miRNA specific probes)
|Study Type :||Observational|
|Estimated Enrollment :||122 participants|
|Official Title:||Circulating miRNAs: Novel Breast Cancer Biomarkers and Their Use for Guiding and Monitoring Response to Chemotherapy|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2021|
Newly diagnosed breast cancer patients
All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy will be recruited and enrolled into this study at the time of diagnosis, pending gaining informed consent.
Recurrent breast cancer patients
All patients with a history of breast cancer who represent with disease recurrence or progression, and are commencing up-front hormonal therapy or chemotherapy, will also be recruited and enrolled.
- Relationship between changes in a patients circulating miRNA expression levels over the course of their systemic therapy, and their response to that treatment. [ Time Frame: up to week 66-92 ]Patients' response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses.
- Correlation of systemic miRNA levels with standard biomarkers of response [ Time Frame: up to week 66-92 ]Standard bio markers of response include serum CEA and Ca15-3 levels
- Relationship between circulating miRNA profiles and patients' intrinsic subtype of breast cancer [ Time Frame: up to week 66-92 ]
- Relationship between miRNA expression levels and other existing clinicopathological parameters. [ Time Frame: up to week 66-92 ]Other existing clinicopathological parameters include: ER, PR and HER2 status, stage of disease,histological grade and size of the tumour, and the Nottingham Prognostic Index.
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): NCT01722851
|Bon Secours Hospital||Recruiting|
|Contact: Contact Person 021-4542807|
|Principal Investigator: Conleth Murphy, Dr|
|Contact: Contact Person 01-8093760|
|Principal Investigator: Arnold Hill, Prof|
|St James's Hospital||Recruiting|
|Contact: Contact person 01 410 3000|
|Principal Investigator: John Kennedy, Dr|
|University Hospital Galway||Recruiting|
|Contact: Contact Person (0)91 524222|
|Principal Investigator: Michael J Kerin, Prof|
|Letterkenny General Hospital||Recruiting|
|Contact: Contact Person 074-9123798|
|Principal Investigator: Karen Duffy, Dr|
|Sligo General Hospital||Recruiting|
|Contact: Contact Person (071) 9171111|
|Principal Investigator: Michael Martin, Dr|