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

Colorectal Cancer Clinical Trial

Official title:

Identification of Plasma Biomarkers in Early Detection of Colorectal Adenocarcinoma Recurrence (C-RAC Plasma Biomarker Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02050737
• Other study ID #: ICORG 12-27
• Status: Terminated
• Start date: October 2013
• Est. completion date: July 13, 2021

Study information

• Verified date: April 2023
• Source: Cancer Trials Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 109
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Ireland	Beacon Hospital	Bracken Rd, Sandyford Industrial Estate	Dublin 18
Ireland	Bon Secours Hosptial	Cork
Ireland	Cork Universtiy Hospital	Cork
Ireland	Letterkenny General Hospital	Donegal
Ireland	Our Lady of Lourdes Hospital Drogheda	Drogheda	Louth
Ireland	Adelaide & Meath Hospital incorporating National Children's Hoptial (AMNCH)	Dublin
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	St James Hospital	Dublin
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

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Trials Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	For the duration of treatment and follow up, expected to be 4 years