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Circulating miRNAs.

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ClinicalTrials.gov Identifier: NCT01722851
Recruitment Status : Active, not recruiting
First Posted : November 7, 2012
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

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.

Condition or disease
Breast Cancer Newly Diagnosed Breast Cancer Recurrent Breast Cancer

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Study Type : Observational
Actual Enrollment : 255 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Breast Cancer Biomarkers and Their Use for Guiding and Monitoring Response to Chemotherapy
Study Start Date : May 2011
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
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 patient who present with metastatic disease who are commencing hormonal therapy only.



Primary Outcome Measures :
  1. 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 ]

    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."


  2. 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


Secondary Outcome Measures :
  1. Relationship between circulating miRNA profiles and patients' intrinsic subtype of breast cancer [ Time Frame: Up to week 66-92 ]
  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Investigators aim to study two populations of breast cancer patients:

  1. Patients undergoing neoadjuvant chemotherapy for breast cancer at tertiary referral breast cancer centres in Ireland.

    For GUH only: Additionally,investigators wish to evaluate miRNA expression levels in patients' diagnostic core biopsies.

  2. Investigators also wish to study the same panel of miRNAs in patients who present with disease recurrence or disease progression, and who are commenced on systemic therapies (hormonal and/or chemotherapy).
Criteria

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.


Information from the National Library of Medicine

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


Locations
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Ireland
Bon Secours Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
St James's Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
Letterkenny General Hospital
Letterkenny, Ireland
Sligo General Hospital
Sligo, Ireland
Midlands Regional Hospital Tullamore
Tullamore, Ireland
Sponsors and Collaborators
Cancer Trials Ireland
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Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT01722851    
Other Study ID Numbers: ICORG 10-11
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Keywords provided by Cancer Trials Ireland:
Breast Cancer
miRNAs
Newly diagnosed
Recurrent
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases