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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.
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This is an exploratory, translational, non-interventional and multi-centre clinical study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival or progression free survival | Identify plasma biomarkers with improved sensitivity to predict early recurrence of CRAC and presence of residual occult metastases following completion of adjuvant chemotherapy | Duration of treatment and follow up, expected to be 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy, sensitivity, specificity and concordance index | To validate a panel of predictive and/or prognostic plasma biomarkers, proving its accuracy, sensitivity, specificity and concordance index. | Duration of treatment and follow up period, expected to be 4 years |
| To investigate the correlation between biomarkers identified in plasma samples with the expression of the same biomarkers at tissue level. |
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Inclusion Criteria:
Exclusion Criteria:
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100 CRAC patients with stage II/III resectable disease due for adjuvant chemotherapy.
30 CRAC patients with stage II resectable disease for observation only.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beacon Hospital | Bracken Rd, Sandyford Industrial Estate | Dublin 18 | Ireland | |||
| Our Lady of Lourdes Hospital Drogheda |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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This allows for further understanding of the role of cancer-related and/or host-related proteins in disease response and progression |
| For the duration of treatment and follow up, expected to be 4 years |
| 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 | 4 | Ireland |
| Mater Misericordiae University Hospital | Dublin | 7 | Ireland |
| St James Hospital | Dublin | 8 | Ireland |
| Beaumont Hospital | Dublin | 9 | Ireland |
| 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |