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Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection

Primary Purpose

HPV-Related Cervical Carcinoma, Low-Grade Squamous Intraepithelial Lesions, HPV Infection

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CO2

About this trial

This is an interventional treatment trial for HPV-Related Cervical Carcinoma focused on measuring high-risk hpv infection, hpv persistent, Lsil, cervical lesions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Aged 18-65 years old with a history of sexual activity. Subclinical infected individuals who have been confirmed as HR-HPV positive (if there is the same positive type in the typing test) for more than 1 year using HPV typing test, HPV E6/E7 mRNA test, HPV DNA test, and cervical triple step diagnostic procedure (cytology colposcopy histopathology). Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year. No fundamental diseases of important organs. Agree to receive treatment and/or follow-up according to regulations and sign an informed consent form. There has been no history of using other drugs related to HPV infection in the past 3 months. Exclusion Criteria: HR-HPV persistent infection. A total hysterectomy has been performed. Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors. Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE). Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids. Pregnant and lactating women. Acute reproductive tract inflammation. Diabetes patients with uncontrolled blood sugar. Patients who do not receive full treatment and follow-up. Those who fail to sign the informed consent form.

Sites / Locations

first affiliated hospital of Wenzhou medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ALA-PDT Group

CO2 Laser Group

Arm Description

PDT involves cervical gel application and 25-minute laser light exposure. The procedure is repeated three times.

CO2 laser therapy ablates cervical lesions with a depth of 7-10mm and a width of 3-5mm in a single session.

Outcomes

Primary Outcome Measures

Regression of Cervical Lesions.

Measure the rate of regression in cervical lesions after three PDT sessions.

Secondary Outcome Measures

Adverse Events.

Monitor and document any adverse events or complications related to CO2 laser treatment.

Full Information

NCT ID

NCT06052033

First Posted

September 18, 2023

Last Updated

September 23, 2023

Sponsor

First Affiliated Hospital of Wenzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT06052033

Brief Title

Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection

Official Title

The Effect of 5-aminolaevulinic Acid Photodynamic Therapy Versus C02 Laser in the Treatment of Persistent Cervical Low-grade Squamous Intraepithelial Lesions With High-risk HPV Infection:A Non-randomized Controlled Trail Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 11, 2023 (Actual)

Primary Completion Date

August 10, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.

Detailed Description

This non-randomized controlled trial aims to compare the effectiveness of two treatments, 5-aminolevulinic acid (5-ALA) photodynamic therapy and CO2 laser, for women with persistent low-grade cervical lesions associated with high-risk HPV infection lasting more than one year. The study's primary objective is to assess which treatment option yields better results. Participants in both groups will undergo specific therapeutic procedures, including 5-ALA photodynamic therapy or CO2 laser treatment. The study will analyze and compare the effects of these therapies on the regression or elimination of cervical lesions, offering valuable insights into the management of persistent low-grade cervical lesions among high-risk HPV-infected women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HPV-Related Cervical Carcinoma, Low-Grade Squamous Intraepithelial Lesions, HPV Infection, Photodynamic Therapy

Keywords

high-risk hpv infection, hpv persistent, Lsil, cervical lesions

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ALA-PDT Group

Arm Type

Experimental

Arm Description

PDT involves cervical gel application and 25-minute laser light exposure. The procedure is repeated three times.

Arm Title

CO2 Laser Group

Arm Type

Other

Arm Description

CO2 laser therapy ablates cervical lesions with a depth of 7-10mm and a width of 3-5mm in a single session.

Intervention Type

Procedure

Intervention Name(s)

CO2

Intervention Description

CO2 laser treatment is a surgical procedure that employs a high-powered carbon dioxide laser beam to precisely ablate cervical lesions. The laser is applied with a depth of 7-10mm and a width of 3-5mm beyond the lesion area in a single session. This intervention aims to address persistent low-grade cervical lesions associated with high-risk HPV infection.

Primary Outcome Measure Information:

Title

Regression of Cervical Lesions.

Description

Measure the rate of regression in cervical lesions after three PDT sessions.

Time Frame

Assessed at 6 months after the last PDT session.

Secondary Outcome Measure Information:

Title

Adverse Events.

Description

Monitor and document any adverse events or complications related to CO2 laser treatment.

Time Frame

Evaluated at 6 months after the CO2 laser treatment.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

YAN HU, PHD

Phone

008613806696807

627830566@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

kowthar mohamed shaie, master

Phone

008615542452638

milgo1995@hotmail.com

Facility Information:

Facility Name

first affiliated hospital of Wenzhou medical university

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325015

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

YAN MUA(A(A( HU, PHD

Phone

+8613806696807

627830566@qq.com

First Name & Middle Initial & Last Name & Degree

KOWTHAR MOHAMED SHAIE, MASTAR

Phone

+15542452638

milgo1995@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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33538338

Citation

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Results Reference

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29851256

Citation

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Results Reference

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Citation

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Results Reference

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PubMed Identifier

23618600

Citation

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Results Reference

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PubMed Identifier

26687616

Citation

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Results Reference

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19524035

Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

Wang X, You L, Zhang W, Ma Y, Tang Y, Xu W. Evaluation of 5-aminolevulinic acid-mediated photodynamic therapy on cervical low-grade squamous intraepithelial lesions with high-risk HPV infection. Photodiagnosis Photodyn Ther. 2022 Jun;38:102807. doi: 10.1016/j.pdpdt.2022.102807. Epub 2022 Mar 11.

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Citation

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Results Reference

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Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection

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