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Plasma Biomarkers C-RAC, ICORG 12-27, V1

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ClinicalTrials.gov Identifier: NCT02050737
Recruitment Status : Active, not recruiting
First Posted : January 31, 2014
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Study Description
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Brief Summary:
This is an exploratory, translational, non-interventional and multi-centre clinical study.

Condition or disease
Colorectal Cancer

Detailed Description:

Cohort A will consist of 100 CRAC patients with stage II/III resectable disease due for adjuvant chemotherapy.

Cohort B will consist of 30 patients with stage II resectable disease for observation only.

Both cohorts will have a follow up period of up to 2 years, post chemotherapy for cohort A and post resection for cohort B.

Study Design
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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Plasma Biomarkers in Early Detection of Colorectal Adenocarcinoma Recurrence (C-RAC Plasma Biomarker Study)
Study Start Date : October 2013
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022
Groups and Cohorts
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Group/Cohort
A - due for adjuvant chemotherapy
Stage II/III colorectal cancer resectable disease due for adjuvant chemotherapy
B - for observation only
Stage II colorectal cancer with resectable disease for observation only


Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival or progression free survival [ Time Frame: Duration of treatment and follow up, expected to be 4 years ]
    Identify plasma biomarkers with improved sensitivity to predict early recurrence of CRAC and presence of residual occult metastases following completion of adjuvant chemotherapy


Secondary Outcome Measures :
  1. Accuracy, sensitivity, specificity and concordance index [ Time Frame: Duration of treatment and follow up period, expected to be 4 years ]
    To validate a panel of predictive and/or prognostic plasma biomarkers, proving its accuracy, sensitivity, specificity and concordance index.

  2. 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 ]
    This allows for further understanding of the role of cancer-related and/or host-related proteins in disease response and progression


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

100 CRAC patients with stage II/III resectable disease due for adjuvant chemotherapy.

30 CRAC patients with stage II resectable disease for observation only.

Criteria

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
Contacts and Locations
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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): NCT02050737


Locations
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Ireland
Beacon Hospital
Bracken Rd, Sandyford Industrial Estate, Dublin 18, Ireland
Our Lady of Lourdes Hospital Drogheda
Drogheda, Louth, Ireland
Bon Secours Hosptial
Cork, Ireland
Cork Universtiy Hospital
Cork, Ireland
Letterkenny General Hospital
Donegal, Ireland
Adelaide & Meath Hospital incorporating National Children's Hoptial (AMNCH)
Dublin, Ireland, 4
Mater Misericordiae University Hospital
Dublin, Ireland, 7
St James Hospital
Dublin, Ireland, 8
Beaumont Hospital
Dublin, Ireland, 9
St Vincent's Hospital
Dublin, Ireland
Galway University Hospital
Galway, Ireland
Midwestern Regional Hosptial, Limerick
Limerick, Ireland
Sligo General Hospital
Sligo, Ireland
Waterford Regional Hospital
Waterford, Ireland
Sponsors and Collaborators
Cancer Trials Ireland
More Information
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Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT02050737    
Other Study ID Numbers: ICORG 12-27
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Keywords provided by Cancer Trials Ireland:
Curative resection
Adjuvant chemotherapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases