Determination of new biomarkers in patients with resectable colorectal liver metastases, the MIRACLE study
- Conditions
- colorectal liver metastases10027476
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
Age >= 18 years.
Histologically confirmed primary colorectal carcinoma.
Radiological confirmed and resectable liver metastasis of colorectal cancer,
planned to undergo resection with or without neo-adjuvant chemotherapy.
Before patient registration, written informed consent must be given according
to ICH/GCP, and national/local regulations.
Prior adjuvant chemotherapy for the primary colorectal carcinoma given <6
months prior to detection of the liver metastases.
Prior non colorectal malignancies, except for patients with basal or squamous
cell carcinoma of the skin, or patients with carcinoma in situ of the cervix.
Presence of extrahepatic disease. Patients with small (<=1 cm) extrahepatic
lesions that are not clearly suspicious of metastases are eligible.
Females with a positive pregnancy test (within 14 days before treatment start).
History of psychiatric disability judged by the investigator to be clinically
significant, precluding informed consent.
Current or recent treatment with another investigational drug or participation
in another investigational study.
Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those
conditions should be discussed with the patient before registration in study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our primary endpoint is recurrence of disease after hepatic resection for<br /><br>colorectal liver metastases within one year after resection. </p><br>
- Secondary Outcome Measures
Name Time Method