Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT02399995
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Colorectal cancer liver metastases (CRLM)
* \> 18 years of age
* Absence of unresectable extrahepatic disease
* No previous liver surgery for CRLM
* Clinical risk score (CRS) \>/= 3 or \> 4 tumors
* CRS includes the following variables;
* Lymph node positive primary
* Disease free interval \<12 months
* CEA level \>200ng/mL (highest CEA level within 6 months prior to surgery, not including day of surgery)
* Tumor size \> 5cm
* Number of tumors \>1(based on most recent scan or pathology before liver resection)
* Each variable is given a score of one and summed to give final CRS
* Clinical risk score (CRS) \< 3 with pending variables that cannot be determined preoperatively
* If CRS is still \< 3 postoperatively, these patients will be excluded and replaced (inevaluable).
* Ability to read and write in English
* Undergoing liver resection/ ablation for CRLM
* Underwent liver resection/ ablation for CRLM, but not their primary tumors
Exclusion Criteria:
* Non-English speaking
* Inability to read and/or write
* International Patients
* Concurrent malignancy (excluding non-melanoma skin cancers)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02399995
Study Brief:
Protocol Section:
NCT02399995