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

The development of innovative technologies increasing diagnosis and treatment efficiency of the cervix background and precancerous diseases associated with HPV

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10428760

Enrollment

200

Registered

2023-07-11

Start date

2023-03-03

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV-associated cervical intraepithelial neoplasia Infections and Infestations

Interventions

The study aims to recruit two cohorts of patients with established HPV and cervical intraepithelial neoplasia (CIN). The main group will consist of 150 participants from the hospital, who will undergo

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. 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. 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. 4. To determine ?ervical intraepithelial neoplasia (CIN) colposcopy is performed 3, 6, 12 months after PDT.	—

Measure

Time frame

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. 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. 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. 4. To determine ?ervical intraepithelial neoplasia (CIN) colposcopy is performed 3, 6, 12 months after PDT.

—

Countries

Kazakhstan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026