Exosomal and Free Extracellular RNAs and Proteins as Predictive. ICORG 10-15, V2
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|ClinicalTrials.gov Identifier: NCT01840306|
Recruitment Status : Active, not recruiting
First Posted : April 25, 2013
Last Update Posted : February 15, 2019
(i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for the existence of RNAs/proteins identified in (i) and (ii).
To develop a predictive model for use in the HER2 positive population based on the most accurate and sensitive combination of the identified biomarkers.
|Condition or disease||Intervention/treatment|
|Breast Cancer HER2 Positive Breast Cancer HER2 Negative Breast Cancer||Other: Biomarker Analysis|
This is a translational pilot study, involving two patient cohorts, designed to identify predictive biomarkers for HER2 targeted therapy, which will be validated in a larger future study.
Cohort 1: 300 newly diagnosed (including metastatic) HER2 positive breast cancer patients. Cohort 2: 30 newly diagnosed HER2 negative breast cancer patients.
Blood specimens will be taken:
- before starting treatment (cohort 1 and 2)
- after receiving chemotherapy and before starting HER2 targeted treatment (if applicable) (cohort 1)
- within one month following 1st treatment of HER2 targeted treatment (cohort 1)
- approximately every 3 months (coinciding with formal disease assessment) while on HER2 targeted treatment for a maximum of 5 years (cohort 1)
Blood will be processed to serum, which will be analysed for RNA and protein biomarkers.
|Study Type :||Observational|
|Estimated Enrollment :||330 participants|
|Official Title:||Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2024|
Cohort 1: HER2 positive breast cancer
Female patients with newly diagnosed (including metastatic) HER2 positive breast cancer.
Other: Biomarker Analysis
Cohort 2: HER2 negative breast cancer
Female patients with newly diagnosed HER2 negative breast cancer
Other: Biomarker Analysis
- Identification of Extra Cellular RNAs/proteins in sera from cancer patients [ Time Frame: 7 years ]Identification of EC RNAs/proteins in sera from cancer patients, which correlate with their response to treatment
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): NCT01840306
|Bracken Rd, Sandyford Industrial Estate, Dublin 18, Ireland|
|Bon Secours Hospital|
|Cork University Hospital|
|Letterkenny General Hospital|
|St James's Hospital|
|St Vincent's University Hospital|
|The Adelaide & Meath Hospital, Dublin Incorporating the National Children's Hospital|
|Sligo General Hospital|