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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT01885702
Eligibility Criteria:
Inclusion Criteria:
* histologically documented evidence of CRC (group I) and Lynch syndrome carrier without signs of disease (group II)
* HLA-A2.1 phenotype is required
* MSI high tumor
* WBC \>3.0 x 109/l, lymphocytes \>0.8 x 109/l, platelets \>100 x 109/l, serum crea¬tinine \<150 µmol/l, serum bilirubin \<25 µmol/l
* WHO performance status 0-1 (Karnofsky 100-70%)
* Age 18-75 years
* Expected adequacy of follow-up
* Written informed consent
Exclusion Criteria:
* History of malignancy in the past 5 years with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Serious active infections, HbsAg or HIV positive (test only in case of high risk or clinical suspicion)
* Autoimmune diseases or organ allografts
* Concomitant use of immunosuppressive drugs
* Known allergy to shell fish
* Pregnant or lactating women
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01885702
Study Brief:
Protocol Section:
NCT01885702