The MIRACLE study

Recruiting

• Conditions: Colorectal Cancer Liver Metastases

• Registration Number: NL-OMON21289
• Lead Sponsor: Prof. Dr. C. Verhoef Erasmus, Head of department of Surgical Oncology, MC Cancer Institute Groene Hilledijk 301, 3075 EA, Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 240

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of disease after hepatic resection for colorectal cancer liver metastases within one year after resection

Secondary Outcome Measures

Name	Time	Method
To identify tumor-specific characteristics of CTC and cfDNA at the molecular level, and to correlate these parameters with the response on chemotherapy and the recurrence rate within 1 year.<br>To answer whether serial measurements of cfDNA and CTCs will provide more adequate information than single point measurement prior to therapy.<br>To address whether or not (serial) assessments of tumor-specific characteristics of CTC and DNA at the molecular level add to the current known prognostic factors in overall survival.