CERVISEG-300-I Study
- Conditions
- Microinvasive carcinoma of the cervix uteri and high grade cervical lesions.
- Registration Number
- RPCEC00000113
- Lead Sponsor
- Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- Not specified
1. Age between 18-65 years inclusive. 2. Histological diagnosis of high grade lesions and microinvasive squamous cell carcinoma of the cervix (stage 1A1 FIGO classification). 3. Presence of residual lesion after the initial punch with diameter = 3 mm, measured by videocolposcopy and corresponding with major changes or invasive stage in the nomenclature of the International Federation of Cervical Pathology and Colposcopy (Barcelona, 2002). 4. Written informed consent and signed by the patient.
1.Patients meeting any one of the following were excluded from entering the study: Chemotherapy or surgical, ablative, radiant, or immunomodulator treatment, up to 3 months before inclusion. 2.Psychiatric dysfunction. 3.Pregnancy and breast-feeding. 4.Chronic diseases such as asthma, diabetes, epilepsy, autoimmune disease, hypertension, anaemia, acute bacterial or mycotic systemic or genital tract infections, renal, hepatic and cardiovascular disorders. 5.Abnormal laboratory tests. 6.Participation in another therapeutic study within 8 weeks prior to inclusion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Security is measured through the following variables: - Adverse events (event number, type, frequency: Yes, No, Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events, Duration: hours, days, months, ratio causality: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death, Treatment indicated: type and dosage of medication, treatment time). - Hematological and biochemical determinations (values ??of hematocrit, platelet count, transaminases, bilirubin, urea, creatinine, glomerular filtration rate). Response time (of the above variables): 24 hours, 15 days and at months 3, 6, 9 and 12 post-treatment.
- Secondary Outcome Measures
Name Time Method - Histological Evaluation (Stage of injury). - colposcopic evaluation (number, size and scale of colposcopic lesions measurable). - Presence of HPV in biopsies (Yes, No). - surrogate markers of response (molecular parameters such as Angiogenesis and Induction of Apoptosis). Response time (of the above variables): at 15 days of completion of treatment.