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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT06199128
Eligibility Criteria:
TREATMENT GROUP
INCLUSION:
* Women aged between 25 and 65 years (inclusive).
* Histological cervical cytology results reported as ASCUS, LSIL/CIN1, with a positive cervical PCR determination for high-risk HPV (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68).
* Patients currently undergoing treatment with the combination of carboxymethyl B-glucan and polycarboxyl (for at least 15 days prior to study initiation)
* Capable of reading and comprehending the patient information sheet and the informed consent form.
* Willing to participate in the study and sign the informed consent form.
EXCLUSION:
* Cervical cytology indicating suspected invasive cervical cancer.
* Ongoing or recent pregnancy terminated within six weeks of the study commencement.
* Clinically significant immunodeficiency-linked pathology.
* Active or terminated immunosuppressive treatment within six months of study entry. Specifically, in the case of corticosteroids, women will be excluded if they are currently or recently receiving corticosteroid treatment (defined as within two weeks prior to study entry) or if they have undergone two or more cycles of corticosteroids at doses equal to or greater than 20 mg/day of Prednisone (or equivalent) orally or parenterally for at least one week's duration in the year prior to study entry.
* Undiagnosed abnormal genital bleeding.
* Total hysterectomy.
* Documented history of cervical pathology caused by HPV.
* Contraindications to the use of the combination of Carboxymethyl B-glucan and polycarboxyl, or known allergies to any of its components.
CONTROL GROUP
INCLUSION:
* Women aged between 25 and 65 years (inclusive).
* Histological cervical cytology results reported as ASCUS, LSIL/CIN1, with a positive cervical PCR determination for high-risk HPV (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68).
* Patients not currently undergoing treatment for HPV.
* Capable of reading and comprehending the patient information sheet and the informed consent form.
* Willing to participate in the study and sign the informed consent form.
EXCLUSION:
* Cervical cytology indicating suspected invasive cervical cancer.
* Ongoing or recent pregnancy terminated within six weeks of the study commencement.
* Clinically significant immunodeficiency-linked pathology.
* Active or terminated immunosuppressive treatment within six months of study entry. Specifically, in the case of corticosteroids, women will be excluded if they are currently or recently receiving corticosteroid treatment (defined as within two weeks prior to study entry) or if they have undergone two or more cycles of corticosteroids at doses equal to or greater than 20 mg/day of Prednisone (or equivalent) orally or parenterally for at least one week's duration in the year prior to study entry.
* Undiagnosed abnormal genital bleeding.
* Total hysterectomy.
* Documented history of cervical pathology caused by HPV.
* Concurrent participation in a clinical study of an investigational drug that could interfere with the current study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT06199128
Study Brief:
Protocol Section:
NCT06199128