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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
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Brief Summary:

Primary Objective:

(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).

Secondary Objective:

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

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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
  • HER2 positive breast cancer:Female patients with newly diagnosed (including metastatic) HER2 positive breast cancer.
  • HER2 negative breast cancer:Female patients with newly diagnosed HER2 negative breast cancer.
Criteria

Inclusion Criteria:

  1. Patient with a newly diagnosed (including metastatic) HER2 positive breast cancer, who is to commence HER2 targeted treatment.

    OR

    - Patient with a newly diagnosed HER2 negative breast cancer, who is to commence any type of treatment.

  2. Patient must be female and aged 18 years or over.
  3. Patient must provide written informed consent.

Exclusion Criteria:

1. 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): NCT01840306


Locations
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Ireland
Beacon Hospital
Bracken Rd, Sandyford Industrial Estate, Dublin 18, Ireland
Bon Secours Hospital
Cork, Ireland
Cork University Hospital
Cork, Ireland
Letterkenny General Hospital
Donegal, Ireland
Beaumont Hospital
Dublin, Ireland
St James's Hospital
Dublin, Ireland
St Vincent's University Hospital
Dublin, Ireland
The Adelaide & Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland
Sligo General Hospital
Sligo, Ireland
Sponsors and Collaborators
Cancer Trials Ireland

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Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT01840306     History of Changes
Other Study ID Numbers: ICORG 10-15
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: October 2018

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases