HPV-Related Cervical CarcinomaNCT06052033
Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection
A study testing CO2 in people with HPV-Related Cervical Carcinoma and Low-Grade Squamous Intraepithelial Lesions, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- HPV-Related Cervical Carcinoma, Low-Grade Squamous Intraepithelial Lesions, HPV Infection
- What is being tested?
- CO2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
first affiliated hospital of Wenzhou medical university
Wenzhou, Zhejiang, 325015
YAN MUA(A(A( HU, PHD, +8613806696807, 627830566@qq.com
KOWTHAR MOHAMED SHAIE, MASTAR, +15542452638, milgo1995@hotmail.com
About this study
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
Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.
Read the 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.
- Conditions
- HPV-Related Cervical Carcinoma, Low-Grade Squamous Intraepithelial Lesions, HPV Infection, Photodynamic Therapy
- Being tested
- CO2
- Keywords
- high-risk hpv infection, hpv persistent, Lsil, cervical lesions
- Medical subject headings
- Squamous Intraepithelial Lesions, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ALA-PDT Group | Experimental | PDT involves cervical gel application and 25-minute laser light exposure. The procedure is repeated three times. Receives: Procedure: CO2 |
| CO2 Laser Group | Other | CO2 laser therapy ablates cervical lesions with a depth of 7-10mm and a width of 3-5mm in a single session. Receives: Procedure: CO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of Cervical Lesions.
Measure the rate of regression in cervical lesions after three PDT sessions.
Measured: Assessed at 6 months after the last PDT session.
Secondary outcomes (1)
Adverse Events.
Monitor and document any adverse events or complications related to CO2 laser treatment.
Measured: Evaluated at 6 months after the CO2 laser treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start11 Sep 2023
- Primary completion10 Aug 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HPV-Related Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YANHU, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052033
- Sponsor's protocol ID
- KY2023-188
- Status last verified
- May 2025
- First submitted
- 18 Sep 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Wang Y, Xue J, Dai X, Chen L, Li J, Wu Y, Hu Y. Distribution and role of high-risk human papillomavirus genotypes in women with cervical intraepithelial neoplasia: A retrospective analysis from Wenzhou, southeast China. Cancer Med. 2018 Jul;7(7):3492-3500. doi: 10.1002/cam4.1559. Epub 2018 May 30.
PubMed 29851256Yang Y, Meng YL, Duan SM, Zhan SB, Guan RL, Yue TF, Kong LH, Zhou L, Deng LH, Huang C, Wang S, Wang GY, Wu DF, Zhang CF, Chen F. REBACIN(R) as a noninvasive clinical intervention for high-risk human papillomavirus persistent infection. Int J Cancer. 2019 Nov 15;145(10):2712-2719. doi: 10.1002/ijc.32344. Epub 2019 Apr 29.
PubMed 30989655Crosbie EJ, Einstein MH, Franceschi S, Kitchener HC. Human papillomavirus and cervical cancer. Lancet. 2013 Sep 7;382(9895):889-99. doi: 10.1016/S0140-6736(13)60022-7. Epub 2013 Apr 23.
PubMed 23618600Fu Y, Bao Y, Hui Y, Gao X, Yang M, Chang J. Topical photodynamic therapy with 5-aminolevulinic acid for cervical high-risk HPV infection. Photodiagnosis Photodyn Ther. 2016 Mar;13:29-33. doi: 10.1016/j.pdpdt.2015.12.004. Epub 2015 Dec 10.
PubMed 26687616Bhowmick R, Girotti AW. Signaling events in apoptotic photokilling of 5-aminolevulinic acid-treated tumor cells: inhibitory effects of nitric oxide. Free Radic Biol Med. 2009 Sep 15;47(6):731-40. doi: 10.1016/j.freeradbiomed.2009.06.009. Epub 2009 Jun 11.
PubMed 19524035Hu Z, Li J, Liu H, Liu L, Jiang L, Zeng K. Treatment of latent or subclinical Genital HPV Infection with 5-aminolevulinic acid-based photodynamic therapy. Photodiagnosis Photodyn Ther. 2018 Sep;23:362-364. doi: 10.1016/j.pdpdt.2018.07.014. Epub 2018 Jul 23.
PubMed 30048762Li D, Zhang F, Shi L, Lin L, Cai Q, Xu Y. Treatment of HPV Infection-Associated Low Grade Cervical Intraepithelial Neoplasia with 5-Aminolevulinic Acid-Mediated Photodynamic Therapy. Photodiagnosis Photodyn Ther. 2020 Dec;32:101974. doi: 10.1016/j.pdpdt.2020.101974. Epub 2020 Aug 21.
PubMed 32835877Wang 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.
PubMed 35288319Navarro Santana B, Sanz Baro R, Orozco R, Plaza Arranz J. Cervical vaporization in LSIL and persistent HPV infection. Taiwan J Obstet Gynecol. 2018 Aug;57(4):475-478. doi: 10.1016/j.tjog.2018.06.010.
PubMed 30122563
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06052033
- Acronym / sponsor ID
- KY2023-188
- Conditions
- HPV-Related Cervical Carcinoma, Low-Grade Squamous Intraepithelial Lesions, HPV Infection, Photodynamic Therapy
- Keywords
- high-risk hpv infection, hpv persistent, Lsil, cervical lesions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALA-PDT Group | Experimental | Procedure: CO2PDT involves cervical gel application and 25-minute laser light exposure. The procedure is repeated three times. |
| CO2 Laser Group | Other | Procedure: CO2CO2 laser therapy ablates cervical lesions with a depth of 7-10mm and a width of 3-5mm in a single session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2CO2 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. | Procedure or surgery | ALA-PDT Group, CO2 Laser Group |
Primary outcome
Regression of Cervical Lesions.
Time frame: Assessed at 6 months after the last PDT session.
Measure the rate of regression in cervical lesions after three PDT sessions.
1 secondary outcome
Adverse Events.
Time frame: Evaluated at 6 months after the CO2 laser treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Results publication: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Results publication: PubMed 29851256Wang Y, Xue J, Dai X, Chen L, Li J, Wu Y, Hu Y. Distribution and role of high-risk human papillomavirus genotypes in women with cervical intraepithelial neoplasia: A retrospective analysis from Wenzhou, southeast China. Cancer Med. 2018 Jul;7(7):3492-3500. doi: 10.1002/cam4.1559. Epub 2018 May 30.
- Results publication: PubMed 30989655Yang Y, Meng YL, Duan SM, Zhan SB, Guan RL, Yue TF, Kong LH, Zhou L, Deng LH, Huang C, Wang S, Wang GY, Wu DF, Zhang CF, Chen F. REBACIN(R) as a noninvasive clinical intervention for high-risk human papillomavirus persistent infection. Int J Cancer. 2019 Nov 15;145(10):2712-2719. doi: 10.1002/ijc.32344. Epub 2019 Apr 29.
- Results publication: PubMed 23618600Crosbie EJ, Einstein MH, Franceschi S, Kitchener HC. Human papillomavirus and cervical cancer. Lancet. 2013 Sep 7;382(9895):889-99. doi: 10.1016/S0140-6736(13)60022-7. Epub 2013 Apr 23.
- Results publication: PubMed 26687616Fu Y, Bao Y, Hui Y, Gao X, Yang M, Chang J. Topical photodynamic therapy with 5-aminolevulinic acid for cervical high-risk HPV infection. Photodiagnosis Photodyn Ther. 2016 Mar;13:29-33. doi: 10.1016/j.pdpdt.2015.12.004. Epub 2015 Dec 10.
- Results publication: PubMed 19524035Bhowmick R, Girotti AW. Signaling events in apoptotic photokilling of 5-aminolevulinic acid-treated tumor cells: inhibitory effects of nitric oxide. Free Radic Biol Med. 2009 Sep 15;47(6):731-40. doi: 10.1016/j.freeradbiomed.2009.06.009. Epub 2009 Jun 11.
- Results publication: PubMed 30048762Hu Z, Li J, Liu H, Liu L, Jiang L, Zeng K. Treatment of latent or subclinical Genital HPV Infection with 5-aminolevulinic acid-based photodynamic therapy. Photodiagnosis Photodyn Ther. 2018 Sep;23:362-364. doi: 10.1016/j.pdpdt.2018.07.014. Epub 2018 Jul 23.
- Results publication: PubMed 32835877Li D, Zhang F, Shi L, Lin L, Cai Q, Xu Y. Treatment of HPV Infection-Associated Low Grade Cervical Intraepithelial Neoplasia with 5-Aminolevulinic Acid-Mediated Photodynamic Therapy. Photodiagnosis Photodyn Ther. 2020 Dec;32:101974. doi: 10.1016/j.pdpdt.2020.101974. Epub 2020 Aug 21.
- Results publication: PubMed 35288319Wang 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.
- Results publication: PubMed 30122563Navarro Santana B, Sanz Baro R, Orozco R, Plaza Arranz J. Cervical vaporization in LSIL and persistent HPV infection. Taiwan J Obstet Gynecol. 2018 Aug;57(4):475-478. doi: 10.1016/j.tjog.2018.06.010.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 in people with HPV-Related Cervical Carcinoma and Low-Grade Squamous Intraepithelial Lesions, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YAN HU, PHD (008613806696807, 627830566@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression of Cervical Lesions. (time frame: Assessed at 6 months after the last PDT session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06052033, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.