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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT01722903
Eligibility Criteria:
Inclusion Criteria:
* Subjects older than 18 years will be included.
* Subjects with colorectal primary carcinomas metastatic to the liver and/or lungs who will undergo a synchronous resection of both primary tumor and liver metastases will also be enrolled.
* Subjects of all genders and ethnicities will be included.
* Subjects with the diagnosis of stage IV primary CRC will be included if metastases are limited to liver and/or lungs at the time of primary surgery.
* The histopathology of the CRC primary tumor must be documented to be adenocarcinoma.
* Subjects with the diagnosis of syn- and metachronous liver and/or lung metastases from colorectal carcinoma will be included, as long as metastases at both sites are resectable by minimal invasive or conventional approach (usually sequentially and not simultaneously).
* Liver and lung metastases must be defined according to radiological criteria. In case of doubt on radiologic findings, percutaneous biopsy will have to be obtained.
* Subjects must be capable of giving informed consent or have an acceptable surrogate capable of giving legally authorized consent on the subject's behalf.
Exclusion Criteria:
* Subjects with the concurrent diagnosis of an active second malignancy besides basal cell carcinoma of the skin will be excluded, if there is evidence of disease burden or the patient is currently treated with chemotherapy.
* Subjects with a Hemoglobin of \<8g/dl in the morning of the procedure will be excluded.
* In subjects who had needed intraoperative transfusions \>4 units of RPBCs, no further blood will be drawn for CTC analysis.
* Pregnant women will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01722903
Study Brief:
Protocol Section:
NCT01722903