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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

Tracking Information
First Submitted Date April 23, 2013
First Posted Date April 25, 2013
Last Update Posted Date February 15, 2019
Study Start Date October 2012
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2013)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01840306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exosomal and Free Extracellular RNAs and Proteins as Predictive. ICORG 10-15, V2
Official Title Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Breast Cancer
  • HER2 Positive Breast Cancer
  • HER2 Negative Breast Cancer
Intervention Other: Biomarker Analysis
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 23, 2013)
330
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2024
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01840306
Other Study ID Numbers ICORG 10-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cancer Trials Ireland
Study Sponsor Cancer Trials Ireland
Collaborators Not Provided
Investigators Not Provided
PRS Account Cancer Trials Ireland
Verification Date October 2018