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Diagnostic Value of the Autofluorescence Colposcopy System for Cervical Lesions

Diagnostic Value of the Autofluorescence Colposcopy System for Cervical Lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113698
Enrollment
Unknown
Registered
2025-12-02
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

High-grade squamous intraepithelial lesion

Interventions

Gold Standard:Colposcopic pathological results
Index test:Autofluorescence Colposcopy

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Women aged 18 to 65 years with a history of sexual activity; 2.Patients with suspicious medical history or signs, such as contact bleeding, abnormal vaginal discharge, abnormal cervical appearance, etc.; those with abnormal screening results, such as cytology showing ASCUS with positive HPV test, cytology showing LSIL or above, or positive for HPV type 16/18; 3.No history of cervical cancer or cervical physical therapy, with a complete cervix; 4.Not in the menstrual period and no sexual intercourse or intravaginal medication within 48 hours; 5.No acute inflammation in the vagina or cervix; 6.Willing to participate in the study after providing informed consent.

Exclusion criteria

Exclusion criteria: 1.Cervical dysplasia (including congenital malformations, didelphys uterus); 2.History of cervical treatment (including conization, ablation, photodynamic therapy, etc.); 3.With definite immunosuppressive conditions, such as HIV infection or organ transplantation,; 4.Patients with severe hemorrhagic diseases such as coagulation disorders, or photosensitive diseases; 5.With concurrent cancer at other sites or a history of radiotherapy or chemotherapy (e.g., pelvic radiotherapy, etc.); 6.The patient is in pregnancy or puerperium; 7.Other conditions deemed inappropriate for the study by the investigators.

Design outcomes

Primary

MeasureTime frame
Histopathological results of colposcopic biopsy;

Countries

China

Contacts

Public ContactWei Wang

Shanghai First Maternity and Infant Hospital

gyfyywangwei@126.com+86 20 83062650

Outcome results

None listed

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