Clinical trial NCT02050737: Plasma Biomarkers C-RAC, ICORG 12-27, V1
Official title: Identification of Plasma Biomarkers in Early Detection of Colorectal Adenocarcinoma Recurrence (C-RAC Plasma Biomarker Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Cancer
Keywords: Curative resection
Adjuvant chemotherapy
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2014-01-31
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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

Primary outcomes:
measure: Disease free survival or progression free survival
timeFrame: Duration of treatment and follow up, expected to be 4 years
Secondary outcomes:
measure: Accuracy, sensitivity, specificity and concordance index
timeFrame: Duration of treatment and follow up period, expected to be 4 years
measure: To investigate the correlation between biomarkers identified in plasma samples with the expression of the same biomarkers at tissue level.
timeFrame: For the duration of treatment and follow up, expected to be 4 years
Other outcomes:
Locations:
city: Bracken Rd, Sandyford Industrial Estate
country: Ireland
facility: Beacon Hospital
state: Dublin 18
city: Drogheda
country: Ireland
facility: Our Lady of Lourdes Hospital Drogheda
state: Louth
city: Cork
country: Ireland
facility: Bon Secours Hosptial
city: Cork
country: Ireland
facility: Cork Universtiy Hospital
city: Donegal
country: Ireland
facility: Letterkenny General Hospital
city: Dublin
country: Ireland
facility: Adelaide & Meath Hospital incorporating National Children's Hoptial (AMNCH)
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: St James Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St Vincent's Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
city: Limerick
country: Ireland
facility: Midwestern Regional Hosptial, Limerick
city: Sligo
country: Ireland
facility: Sligo General Hospital
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
Study officials:
References: