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Study on the establishment of early diagnosis of cervical cancer

Study on the establishment of early diagnosis of cervical cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-17012315
Enrollment
Unknown
Registered
2017-08-09
Start date
2016-07-01
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

cervical cancer

Interventions

cytology is HSIL/ASC-H:cervical conization
Punch biopsy is HSIL:cervical conization
Patient with any one of following conditions below: HPV16/18 positive, cytology finds ASCUS with HPV positive, or AGC with HPV positive, or LSIL(HPV test is not necessary), colposcopy finds HSIL with

Sponsors

The Obstetrics and Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged 25-65 years old; 2) The result of cytology is HSIL/ASC-H(HPV test is not necessary), no matter what the result of colposcopy and histologic biopsy are. A total of 1000 cases are needed; 3) Punch biopsy is HSIL, no matter what the result of colposcopy and cytology are. A total of 1000 cases are needed; 4) Any one of the conditions below: HPV16/18 is positive,cytology is ASCUS with HPV positive, cytology is AGC with HPV positive, cytology is LSIL(HPV test is not necessary), the result of colposcopy is HSIL with biopsy LSIL. A total of 1000 cases are needed; 5) Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patient was treated by cervical conization; 2) Acute inflammation of the pelvic cavity and lower reproductive tract; 3) Patients in pregnancy, unless highly suspected cervical infiltration cancer; 4) Patients with severe underlying diseases, which may result in the inability to therapy safely. These diseases include but not limited to persistent or active infection, symptomatic congestive heart failure, unstable angina,arrhythmia, mental disorder, social situations (which may limit the compliance of patients to the research requirements).

Design outcomes

Primary

MeasureTime frame
cytology;High risk HPV test;colposcope;

Countries

China

Contacts

Public ContactLong Sui

The Obstetrics and Gynecology Hospital of Fudan University

suilong@fudan.edu.cn+86 13801788118

Outcome results

None listed

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