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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50622

Enrollment

240

Registered

2015-06-05

Start date

2015-10-21

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal liver metastases

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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

Exclusion criteria: Prior adjuvant chemotherapy for the primary colorectal carcinoma given

Design outcomes

Primary

Measure	Time frame
Our primary endpoint is recurrence of disease after hepatic resection for colorectal liver metastases within one year after resection.	—

Secondary

Measure	Time frame
- Improve the selection of patients who respond to neoadjuvant chemotherapy. - Improve the selection of patients who will have a complete response after neoadjuvant chemotherapy. - 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. - To objectify whether serial measurements of cfDNA and CTCs will provide more adequate information than single point measurement prior to therapy. - 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. - To determine if cfDNA in patients who are recurrence free after >1 year can be used to discriminate between patients who will still develop recurrence during at least 2 remaining years of follow-up. - To determine reference values and the incidence of elevated cfDNA upon diagnosis of recurrence (within 12 months) and prior to start of treatment.	—

Measure

Time frame

- Improve the selection of patients who respond to neoadjuvant chemotherapy. - Improve the selection of patients who will have a complete response after neoadjuvant chemotherapy. - 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. - To objectify whether serial measurements of cfDNA and CTCs will provide more adequate information than single point measurement prior to therapy. - 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. - To determine if cfDNA in patients who are recurrence free after >1 year can be used to discriminate between patients who will still develop recurrence during at least 2 remaining years of follow-up. - To determine reference values and the incidence of elevated cfDNA upon diagnosis of recurrence (within 12 months) and prior to start of treatment.

—

Countries

Netherlands

Outcome results