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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 April 2023 |
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Main ID: |
NCT02050737 |
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Date of registration:
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23/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Plasma Biomarkers C-RAC, ICORG 12-27, V1
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Scientific title:
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Identification of Plasma Biomarkers in Early Detection of Colorectal Adenocarcinoma Recurrence (C-RAC Plasma Biomarker Study) |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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109 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02050737 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Ireland
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient must be able to give written informed consent
- Histologically or cytologically confirmed CRAC
- Cohort A: colorectal cancer patients with stage II/III resectable disease due for
adjuvant chemotherapy OR Cohort B: colorectal cancer patients with stage II resectable
disease for observation only
- Age = 18 years
- Treatment with curative intent
- Eastern Cooperative Oncology Group (ECOG) Performance status 0 - 2
Exclusion Criteria:
- Presence of a medical or psychiatric condition, which, in the opinion of the
investigator, would potentially pose a risk to the patient when participating in this
trial
- Evidence of a metastatic disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Primary Outcome(s)
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Disease free survival or progression free survival
[Time Frame: Duration of treatment and follow up, expected to be 4 years]
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Secondary Outcome(s)
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Accuracy, sensitivity, specificity and concordance index
[Time Frame: Duration of treatment and follow up period, expected to be 4 years]
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To investigate the correlation between biomarkers identified in plasma samples with the expression of the same biomarkers at tissue level.
[Time Frame: For the duration of treatment and follow up, expected to be 4 years]
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Secondary ID(s)
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ICORG 12-27
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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