Plasma Biomarkers C-RAC, ICORG 12-27, V1
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02050737 |
Recruitment Status :
Terminated
(As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.)
First Posted : January 31, 2014
Last Update Posted : January 21, 2022
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Condition or disease |
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Colorectal Cancer |
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 Type : | Observational |
Actual Enrollment : | 109 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) |
Actual Study Start Date : | October 2013 |
Actual Primary Completion Date : | July 13, 2021 |
Actual Study Completion Date : | July 13, 2021 |
Group/Cohort |
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A - due for adjuvant chemotherapy
Stage II/III colorectal cancer resectable disease due for adjuvant chemotherapy
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B - for observation only
Stage II colorectal cancer with resectable disease for observation only
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- 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
- 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.
- 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

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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 |
100 CRAC patients with stage II/III resectable disease due for adjuvant chemotherapy.
30 CRAC patients with stage II resectable disease for observation only.
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

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
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 |
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: | January 21, 2022 |
Last Verified: | January 2022 |
Curative resection Adjuvant chemotherapy |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |