Cervical Intraepithelial NeoplasiaPhase 2NCT02631863
Aminolaevulinic Acid Photodynamic Therapy for HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)
A Phase 2 study testing Aminolaevulinic acid in people with Cervical Intraepithelial Neoplasia and Low-Grade Squamous Intraepithelial Lesions, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 4 sites in China.
Trial summary
This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid for the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia (LSIL;CIN1). Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Low-Grade Squamous Intraepithelial Lesions, Papillomavirus Infections
- What is being tested?
- Aminolaevulinic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesChina
- Study dates
- 22 Mar 2016to 24 Nov 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women, 25-50 years of age
- Diagnosed with LSIL/CIN1 by local pathology (biopsy) and high-risk HPV positive by HC2 assay within the last 3 months
- Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin )
- Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial; no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
- Written informed consent signed
Who cannot join
- ASC-H (atypical squamous cells, cannot exclude HSIL) or HSIL (high-grade squamous intraepithelial lesions) or AGC (atypical glandular cells) or AIS (adenocarcinoma in situ) on cytology, or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
- Invasive carcinoma possibility or lesions extending to the vaginal vault or suspicion of endocervical disease on colposcopy
- Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
- Undiagnosed vaginal bleeding
- With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
- With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions; patients with malignant tumors
Show all 11Show fewer
- Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin > 1.5 upper limit of normal [ULN], or serum creatinine or blood urea nitrogen > 1.5 ULN)
- Pregnancy or nursing
- Previous physical therapy of LSIL/CIN1 after pathologic diagnosis
- Participation in any clinical studies within the last 30 days
- Subjects that the investigators judged to be not suitable to participate the study besides above
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
About this study
Official title: A Pilot Study of Photodynamic Therapy (PDT) Using Aminolaevulinic Acid (ALA) in Patients With HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)
This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid for the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia (LSIL;CIN1).
- Conditions
- Cervical Intraepithelial Neoplasia, Low-Grade Squamous Intraepithelial Lesions, Papillomavirus Infections
- Being tested
- Aminolaevulinic acid, Placebo
- Medical subject headings
- Uterine Cervical Dysplasia, Squamous Intraepithelial Lesions, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolaevulinic acidDrug
Aminolaevulinic acid with illumination
PlaceboDrug
Placebo with illumination
| Study group | Role | What they receive |
|---|---|---|
| ALA | Experimental | Patients will receive 3 topical treatments of aminolaevulinic acid 500mg Receives: Drug: Aminolaevulinic acid |
| Placebo | Placebo comparator | Patients will receive 3 topical treatments of placebo 500mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Based on histology, cytology and HPV status. "Response" is defined as: 1) pathology and cytology were both normal; 2) pathology and/or cytology showed low grade and the baseline HPV infection was cleared.
Measured: 3 months after treatments
Complete response rate
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Measured: 3 months after treatments
Clearance of high risk HPV
Proportion of patients with high risk HPV clearance
Measured: 3 months after treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study start22 Mar 2016
- Primary completion24 Nov 2018
- Study completion24 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beihua Kong, MD, Principal investigator, Qilu Hospital of Shandong UniversityYouzhong Zhang, MD, Principal investigator, Qilu Hospital of Shandong UniversityJining Tao, Study director, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631863
- Sponsor's protocol ID
- FDZJALA-201510
- Status last verified
- Jul 2019
- First submitted
- 12 Dec 2015
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Photodynamic Therapy (PDT) Using Aminolaevulinic Acid (ALA) in Patients With HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)
- ClinicalTrials.gov ID
- NCT02631863
- Acronym / sponsor ID
- FDZJALA-201510
- Conditions
- Cervical Intraepithelial Neoplasia, Low-Grade Squamous Intraepithelial Lesions, Papillomavirus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- 24 Nov 2018 (actual)
- Study completion
- 24 Nov 2018 (actual)
- First posted
- 16 Dec 2015 (estimated)
- 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.
This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid for the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia (LSIL;CIN1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALA | Experimental | Drug: Aminolaevulinic acidPatients will receive 3 topical treatments of aminolaevulinic acid 500mg |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive 3 topical treatments of placebo 500mg |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Premenopausal women, 25-50 years of age
- Diagnosed with LSIL/CIN1 by local pathology (biopsy) and high-risk HPV positive by HC2 assay within the last 3 months
- Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin )
- Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial; no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
- Written informed consent signed
Key exclusion criteria (11 listed)
- ASC-H (atypical squamous cells, cannot exclude HSIL) or HSIL (high-grade squamous intraepithelial lesions) or AGC (atypical glandular cells) or AIS (adenocarcinoma in situ) on cytology, or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
- Invasive carcinoma possibility or lesions extending to the vaginal vault or suspicion of endocervical disease on colposcopy
- Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
- Undiagnosed vaginal bleeding
- With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
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 |
|---|---|---|
| Aminolaevulinic acidAminolaevulinic acid with illumination | Drug | ALA |
| PlaceboPlacebo with illumination | Drug | Placebo |
Primary outcome
Response rate
Time frame: 3 months after treatments
Based on histology, cytology and HPV status. "Response" is defined as: 1) pathology and cytology were both normal; 2) pathology and/or cytology showed low grade and the baseline HPV infection was cleared.
Complete response rate
Time frame: 3 months after treatments
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Clearance of high risk HPV
Time frame: 3 months after treatments
Proportion of patients with high risk HPV clearance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
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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. This study is not recruiting at the moment.
Beihua Kong, MD principal investigator
Qilu Hospital of Shandong University
Youzhong Zhang, MD principal investigator
Qilu Hospital of Shandong University
Jining Tao study director
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aminolaevulinic acid in people with Cervical Intraepithelial Neoplasia and Low-Grade Squamous Intraepithelial Lesions, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 4 sites 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 3 months after treatments). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.