The Predictive Role of HPV Integration in HSIL and Cervical Cancer
Sponsor
Tongji Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05300243
Collaborator
(none)
1
1
22.8
0
Study Details
Study Description
Brief Summary
The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
1 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Predictive Role of HPV Integration in HSIL and Cervical Cancer
Actual Study Start Date
:
Jul 7, 2020
Anticipated Primary Completion Date
:
Apr 1, 2022
Anticipated Study Completion Date
:
Jun 1, 2022
Outcome Measures
Primary Outcome Measures
- Tissue pathological diagnosis [1year since HPV integrated test]
Tissue pathological diagnosis in 1 year since HPV integrated test
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- HPV-positive patients； Patients have completed HPV detection, TCT, and HPV integration detection before surgery or biopsy； Patients with priced diagnoses accepted treatment according to ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors； Patients who are voluntary participants in this research and cooperate to follow-up with subscribing informed consent.
Exclusion Criteria:
- Patients who are not suitable for the trial； Patients existing other subtype malignancy tumors are still in treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | China | 350000 |
Sponsors and Collaborators
- Tongji Hospital
Investigators
- Principal Investigator: Shuang Li, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Tongji Hospital
ClinicalTrials.gov Identifier:
NCT05300243
Other Study ID Numbers:
- 2021-S140
First Posted:
Mar 29, 2022
Last Update Posted:
Mar 29, 2022
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: