Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT07009327
NCT07009327RecruitingNot Applicable

Efficacy and Safety of Photodynamic Therapy for Cervical Intraepithelial Neoplasia 3(CIN3):A Multicenter Prospective Cohort Study

Peking University Third Hospital2 sites in 1 country100 target enrollmentStarted: January 1, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
2
Primary Endpoint
Efficacy of the treatment
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To investigate the efficacy and safety of photodynamic therapy (20% 5-amino-ketovalerate 630nm red light) in the treatment of cervical intraepithelial neoplasia 3(CIN 3)in women in the real world

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •CIN3, photodynamic therapy was required,
  • •type 1 2 transformation area, colposcopy was sufficient
  • •the lesion boundary was completely visible
  • •The ECC did not indicate high-grade lesions

Exclusion Criteria

  • •coexistence or suspicion of cancer;
  • •involving glands
  • •Porphyria patients, or suspected allergic to red and blue light.
  • •severe medical comorbidities；

Outcomes

Primary Outcomes

Efficacy of the treatment

Time Frame: 1 month after the treatment

colposcopy and biopsy will be performed one month after the treatment. Patients will be categorised as having complete remission(CR) if biopsy confirmed LSIL. If CIN 2 was found after the first course of PDT, it would be categorised as partial remission(PR). Those with the same grade were categorised as persistent disease(PD). The proportion of CR after PDT treatment.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Recruiting
Not Applicable
Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia
NCT06982976Peking University Third Hospital250
Not yet recruiting
Phase 1
Therapeutic efficacy and safety of photodynamic therapy in patients with central serous chorioretinopathyCentral serous chorioretinopathy
JPRN-UMIN000025069Hyogo college of Medicine50
Not yet recruiting
Phase 3
Effect of photodynamic therapy on chronic periodontitisChronic periodontitis.Chronic periodontitisK05.3
IRCT20231112060032N1Mashhad University of Medical Sciences35
Not yet recruiting
Phase 2
Safety and efficacy of photodynamic therapy (with riboflavin as sensitizer) for treatment of malaria in adult Nigerian populatioMalaria
PACTR201912897645869Future Minds Development Initiative200
Enrolling By Invitation
Not Applicable
Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary MolarsPhotodynamic Therapy
NCT05820750Mansoura University60
Efficacy and Safety of Photodynamic... | Clinical Trial