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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

April 23, 2013
April 25, 2013
February 15, 2019
October 2012
August 2023   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01840306 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Exosomal and Free Extracellular RNAs and Proteins as Predictive. ICORG 10-15, V2
Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
  • 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.
  • Breast Cancer
  • HER2 Positive Breast Cancer
  • HER2 Negative Breast Cancer
Other: Biomarker Analysis
  • Cohort 1: HER2 positive breast cancer
    Female patients with newly diagnosed (including metastatic) HER2 positive breast cancer.
    Intervention: Other: Biomarker Analysis
  • Cohort 2: HER2 negative breast cancer
    Female patients with newly diagnosed HER2 negative breast cancer
    Intervention: Other: Biomarker Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
330
Same as current
August 2024
August 2023   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
 
NCT01840306
ICORG 10-15
No
Not Provided
Not Provided
Cancer Trials Ireland
Cancer Trials Ireland
Not Provided
Not Provided
Cancer Trials Ireland
October 2018