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A multicenter, prospective study on HPV E6/E7 mRNA detection (LAMP-LFA method) for cervical cancer screening

A multicenter, prospective study on HPV E6/E7 mRNA detection (LAMP-LFA method) for cervical cancer screening

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102845
Enrollment
Unknown
Registered
2025-05-21
Start date
2025-05-31
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Cervical cancer

Interventions

Gold Standard:HPV DNA detection, mRNA detection and protein detection
Index test:1. RNA was extracted from vaginal secretion samples, and loop mediated isothermal amplification (lamp) was performed using two fluorescently labeled primers and probes, respectively. 2. loa

Sponsors

The First Affiliated Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>25 years old, female; 2. Have undergone vaginal HPV testing within the past 3 months, with known 16/18 HPV infection status, and have not received anti HPV treatment; 3. Gynecological patients with clinically or pathologically confirmed cervical cancer, high-grade cervical intraepithelial tumors, and non cervical diseases; 4. Complete records of medical records and related test results; 5. Complete cervix; 6.Voluntarily participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previous history of cervical conization or hysterectomy; 2. History of pelvic and abdominal radiotherapy and chemotherapy in the past; 3. History of malignant tumors in other parts of the body; 4. Severe intellectual disability or disability, unable to perform vaginal secretion self sampling or unable to sign informed consent forms.

Design outcomes

Primary

MeasureTime frame
Testing line and quality control line;Sensitivity;Specificity;Rate of accuracy;Rate of coincidence;

Countries

China

Contacts

Public ContactGuan Yutao

The First Affiliated Hospital of Ningbo University

2309732100@qq.com+86 135 6603 6278

Outcome results

None listed

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