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 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT00988559
Eligibility Criteria:
Inclusion Criteria:
* patients with high grade cervical intraepithelial lesions (CIN2/3)
* patients whose lesions are HPV16+
* patients who are age 18 or older
* patients who are able to give informed consent
* patients who are immunocompetent
* patients who are not pregnant, committed to using adequate contraception if of childbearing age
* patients who have a minimum hemoglobin level of 9
Exclusion Criteria:
* Patients with cytologic evidence of glandular dysplasia
* Patients with cytologic evidence of adenocarcinoma in situ
* Patients who are pregnant
* Patients with an active autoimmune disease
* Patients who are taking immunosuppressive medication
* Patients with concurrent malignancy except for nonmelanoma skin lesions
* Patients who have an allergy to gold.
* Patients with any evidence of damaged skin, or moles, scars, tattoos or marks at the proposed site(s) of administration that might interfere with the interpretation of local skin reactions.
* History or evidence of a physician-diagnosed chronic or recurrent inflammatory skin disease (e.g. psoriasis, eczema, atopic dermatitis, hypersensitivity) at the proposed site of administration in the past 5 years.
* Patients who have an active autoimmune disease or history of autoimmune disease requiring medical treatment with systemic immunosuppressants, including: inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis, SLE, and Sjogren's syndrome, sarcoidosis. Asthma or COPD that does not require systemic corticosteroids or routine use of inhaled steroids is acceptable
* Patients who have received prior chrysotherapy (administration of gold salts to treat rheumatoid arthritis).
* Patients with a history of arterial or venous thrombosis
* Patients with non-healed wounds.
* Patients with a history of keloid formation ( ID delivery group only)
* Patients with a history of hepatitis B with persistent infection.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00988559
Study Brief:
Protocol Section:
NCT00988559