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TerminatedNCT02050737Updated Jul 8, 2025

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

An observational study in Colorectal Cancer, sponsored by Cancer Trials Ireland. Terminated at 14 sites in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Cancer Trials Ireland · Observational

Why this study was 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.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
109
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Curative resection
  • Adjuvant chemotherapy
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 109 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Cancer Trials Ireland is the lead sponsor of 69 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
109 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Duration of treatment and follow up, expected to be 4 years

Secondary outcomes

  1. 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.

    Time frame: Duration of treatment and follow up period, expected to be 4 years

  2. 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

    Time frame: For the duration of treatment and follow up, expected to be 4 years

07

Study locations

14 sites
  • 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, 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02050737
Lead sponsor
Cancer Trials Ireland
Responsible party
Sponsor
First posted
Jan 31, 2014
Start date
Oct 2013
Primary completion
Jul 13, 2021
Completion
Jul 13, 2021
Last update
Jul 8, 2025
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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