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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT01693835
Eligibility Criteria:
Inclusion Criteria for patients:
* Histologically-confirmed metastatic colorectal cancer;
* 0 to 3 prior chemotherapy lines;
* Signed informed consent;
* Good understanding of the protocol and of the follow-up;
* Estimated life expectancy exceeding 3 months;
* At least one measurable metastatic lesion (RECIST criteria);
* Performance Status (WHO) of 0 to 2;
* Good haematological, hepatic and renal functions.
Inclusion criteria for healthy subject
* Age ≥ 18 ans
* Signed informed consent;
* Good understanding of the protocol and of the follow-up;
* Good haematological, hepatic and renal functions.
* Test HIV and B and C hepatitis negative test
* No chronic or acute diseases
Exclusion Criteria for patients:
* Poor performance status (\>2);
* Poor haematological, hepatic or renal functions;
* Uncontrolled chronic disease;
* Serious unhealed wound, ulcer or fracture within the previous month;
* Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
* Pregnancy or breast-feeding during the previous month;
* Transmeridian trip of more than 4 time zones within the prior 2 weeks;
* Person with legal restriction to participate into clinical research, according to the current law in France.
Exclusion criteria for healthy subject:
* Poor haematological, hepatic or renal functions;
* Uncontrolled chronic disease;
* Serious unhealed wound, ulcer or fracture within the previous month;
* Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
* Pregnancy or breast-feeding during the previous month;
* Transmeridian trip of more than 4 time zones within the prior 2 weeks;
* Person with legal restriction to participate into clinical research, according to the current law in France.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01693835
Study Brief:
Protocol Section:
NCT01693835