Colorectal CancerNCT02050737
Plasma Biomarkers C-RAC, ICORG 12-27, V1
An observational study of Colorectal Cancer, run by Cancer Trials Ireland at 14 sites in Ireland.
Trial summary
This is an exploratory, translational, non-interventional and multi-centre clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 109 participants
- Where
- 14 sitesIreland
- Study dates
- Oct 2013to 13 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Ireland14 sites
Beacon Hospital
Bracken Rd, Sandyford Industrial Estate, Dublin 18
Bon Secours Hosptial
Cork
Cork Universtiy Hospital
Cork
Letterkenny General Hospital
Donegal
Our Lady of Lourdes Hospital Drogheda
Drogheda, Louth
Adelaide & Meath Hospital incorporating National Children's Hoptial (AMNCH)
Dublin, 4
Mater Misericordiae University Hospital
Dublin, 7
St James Hospital
Dublin, 8
Beaumont Hospital
Dublin, 9
St Vincent's Hospital
Dublin
Galway University Hospital
Galway
Midwestern Regional Hosptial, Limerick
Limerick
Sligo General Hospital
Sligo
Waterford Regional Hospital
Waterford
About this study
Official title: Identification of Plasma Biomarkers in Early Detection of Colorectal Adenocarcinoma Recurrence (C-RAC Plasma Biomarker Study)
This is an exploratory, translational, non-interventional and multi-centre clinical study.
Read the 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.
- Conditions
- Colorectal Cancer
- Keywords
- Curative resection, Adjuvant chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of treatment and follow up, expected to be 4 years
Secondary outcomes (2)
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.
Measured: 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.
This allows for further understanding of the role of cancer-related and/or host-related proteins in disease response and progression
Measured: For the duration of treatment and follow up, expected to be 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startOct 2013
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050737
- Sponsor's protocol ID
- ICORG 12-27
- Status last verified
- Jul 2025
- First submitted
- 23 Jan 2014
- Last updated
- 8 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Plasma Biomarkers in Early Detection of Colorectal Adenocarcinoma Recurrence (C-RAC Plasma Biomarker Study)
- ClinicalTrials.gov ID
- NCT02050737
- Acronym / sponsor ID
- ICORG 12-27
- Conditions
- Colorectal Cancer
- Keywords
- Curative resection, Adjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Oct 2013 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Accuracy, sensitivity, specificity and concordance index
Time frame: 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.
Time frame: For the duration of treatment and follow up, expected to be 4 years
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Cancer Trials Ireland at 14 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival or progression free survival (time frame: Duration of treatment and follow up, expected to be 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.