The development of technologies increasing diagnosis and treatment efficiency of the cervix diseases associated with human papillomavirus (HPV)

Not Applicable

• Conditions: HPV-associated cervical intraepithelial neoplasia; Infections and Infestations

• Registration Number: ISRCTN10428760
• Lead Sponsor: Ministry of Science and Higher Education of the Republic of Kazakhstan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-11
• Last Update Posted: 25 July 2023
• Study Completion: 2024-08-10

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Female
2. Age 18 - 45 years old
3. Established diagnosis of CIN
4. Positive PCR result for HPV
5. Lack of surgical treatment of CIN / absence of conization of the cervix
6. Kazakh nationality

Exclusion Criteria

1. Male
2. Age under 18 and over 45 years
3. Surgical treatment of CIN / conization of the cervix
4. Persons mentally or legally incompetent, which prevents obtaining informed consent
5. Pregnant or lactating women
6. Acute gonococcal and non-gonococcal infections of the urethra and lower reproductive tract
7. Severe and decompensated diseases of the liver and kidneys, cardiovascular system
8. Autoimmune diseases
9. Oncological diseases
10. Porphyria and other photoallergic conditions
11. Taking anticoagulants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Differential detection and quantitative determination of HPV, as well as a test for ureaplasmosis, mycoplasmosis, candidiasis are performed using the Real-time CFX96 Touch amplifier (USA) 3, 6, 12 months after PDT

Secondary Outcome Measures

Name	Time	Method
1. Full blood count is measured using the hematology analyzer Sysmex XN-3000 (Japan) at the 5th day and 3, 6, 12 months after PDT.<br>2. CD3, CD4, CD8, CD19, CD16, CD 56 are measured using the flow cytometer BD FACSCanto II Becton Dickinson (USA) at the 5th day and 3, 6, 12 months after PDT.<br>3. Interleukin 1, interleukin 6, and tumor necrosis factor are measured using the enzyme immunoassay at the Freedom EVOlyzer (Tecan, Austria) at the 5th day and 3, 6, 12 months after PDT.<br>4. To determine ?ervical intraepithelial neoplasia (CIN) colposcopy is performed 3, 6, 12 months after PDT.<br>