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Clinical Trials/NL-OMON50622
NL-OMON50622
Recruiting
Not Applicable

Determination of new biomarkers in patients with resectable colorectal liver metastases, the MIRACLE study - MIRACLE

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
colorectal liver metastases
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
240
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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