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Clinical Trials/NL-OMON21289
NL-OMON21289
Recruiting
Not Applicable

Determination of new biomarkers in patients with resectable colorectal liver metastases

Prof. Dr. C. Verhoef Erasmus, Head of department of Surgical Oncology, MC Cancer Institute Groene Hilledijk 301, 3075 EA, Rotterdam0 sites240 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Prof. Dr. C. Verhoef Erasmus, Head of department of Surgical Oncology, MC Cancer Institute Groene Hilledijk 301, 3075 EA, 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 non invasive

Investigators

Sponsor
Prof. Dr. C. Verhoef Erasmus, Head of department of Surgical Oncology, MC Cancer Institute Groene Hilledijk 301, 3075 EA, Rotterdam

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.
  • Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin.
  • 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.

Outcomes

Primary Outcomes

Not specified

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