Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:45 AM
Study NCT ID:
NCT07306260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-29
First Post:
2025-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 560}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2025-12-14', 'studyFirstSubmitQcDate': '2025-12-14', 'lastUpdatePostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Impact on cervical anatomy and function', 'timeFrame': '2 years', 'description': 'Cervical length and function before and after treatment, and subsequent pregnancy outcomes in patients desiring fertility.'}, {'measure': 'Adverse events', 'timeFrame': '2 years', 'description': 'Record post-treatment adverse events including bleeding, infection, and pain.'}], 'primaryOutcomes': [{'measure': 'Lesion effective rate', 'timeFrame': '6 months', 'description': 'Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 6 months post-treatment as the primary endpoint.'}], 'secondaryOutcomes': [{'measure': 'Lesion effective rate', 'timeFrame': '2 years', 'description': 'Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 12 and 24 months post-treatment.'}, {'measure': 'HPV clearance rate', 'timeFrame': '2 years', 'description': 'HPV clearance rates at 3, 6, 9, 12, and 24 months post-treatment'}, {'measure': 'Lesion cure rate', 'timeFrame': '2 years', 'description': 'Proportion of patients with normal colposcopy-guided cervical biopsy results and negative HPV'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['photodynamic therapy', 'High Grade Squamous Intraepithelial Lesion', 'human papillomavirus', 'loop electrosurgical excision procedure', 'efficacy'], 'conditions': ['HSIL, High Grade Squamous Intraepithelial Lesion', 'CIN 2', 'HPV (Human Papillomavirus)-Associated', 'Photodynamic Therapy (PDT)']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.', 'detailedDescription': 'This study aims to conduct a multicenter, prospective, concurrent non-controlled clinical trial to evaluate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) compared with loop electrosurgical excision procedure (LEEP) in patients with high-grade squamous intraepithelial lesion (HSIL/CIN2), using a non-inferiority design. The primary objective is to demonstrate that ALA-PDT is non-inferior to LEEP with respect to key efficacy endpoints. Furthermore, the safety profiles, cervical tissue regeneration outcomes, and long-term prognoses of both treatment modalities will be comprehensively assessed. The results are anticipated to provide robust clinical evidence supporting ALA-PDT as a safer, less invasive, and function-preserving alternative for the management of HSIL/CIN2.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female, 25-60 years, understands study procedures and consents to participate;\n2. Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;\n3. Provides written informed consent.\n\nExclusion Criteria:\n\n1. Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;\n2. Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;\n3. Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;\n4. Undiagnosed vaginal bleeding;\n5. Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents;\n6. Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies;\n7. Pregnant or breastfeeding women;\n8. History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser);\n9. Use of interferon or antiviral therapy within 3 months;\n10. Any other condition deemed unsuitable for participation by the investigator.'}, 'identificationModule': {'nctId': 'NCT07306260', 'acronym': 'PDT for CIN2', 'briefTitle': 'Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2', 'orgStudyIdInfo': {'id': '2025-1382'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALA-PDT Group', 'description': 'ALA-PDT treatment for cervical lesions 6 to 9 times', 'interventionNames': ['Procedure: ALA-PDT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LEEP Group', 'description': 'LEEP surgery for cervical lesions', 'interventionNames': ['Procedure: LEEP surgery']}], 'interventions': [{'name': 'ALA-PDT', 'type': 'PROCEDURE', 'description': 'Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.', 'armGroupLabels': ['ALA-PDT Group']}, {'name': 'LEEP surgery', 'type': 'PROCEDURE', 'description': 'After anesthesia, cervical iodine staining was performed, followed by LEEP.', 'armGroupLabels': ['LEEP Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Ying Li', 'role': 'CONTACT', 'email': '17550215@qq.com', 'phone': '13705815380'}], 'facility': "Women's Hospital School Of Medicine Zhejiang University", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Hongkai Shang, Doctor', 'role': 'CONTACT', 'email': '806520681@qq.com', 'phone': '15990032799'}], 'facility': "First People's Hospital of Hangzhou", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Lifang You', 'role': 'CONTACT', 'email': 'y20042668@sina.com', 'phone': '18958174527'}, {'role': 'CONTACT', 'email': 'y20042668@sina.com'}], 'facility': "Hangzhou Linping District first People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Juanjuan Shi', 'role': 'CONTACT', 'email': 'bessalice0707@163.com', 'phone': '138 8449 6502'}], 'facility': 'First Affiliated Hospital of Ningbo University', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Shaoxing', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Huaqin Pang', 'role': 'CONTACT', 'email': 'hqpang@163.com', 'phone': '13625757126'}, {'role': 'CONTACT', 'email': 'hqpang@163.com'}], 'facility': "Shaoxing People's Hospital", 'geoPoint': {'lat': 30.00237, 'lon': 120.57864}}], 'centralContacts': [{'name': 'Xiaoyun Wang, Doctor', 'role': 'CONTACT', 'email': 'doctorwangxy@zju.edu.cn', 'phone': '15168479997'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': "Women's Hospital School Of Medicine Zhejiang University", 'class': 'OTHER'}, {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Ningbo University', 'class': 'NETWORK'}, {'name': "Shaoxing People's Hospital", 'class': 'OTHER'}, {'name': "Linping First People's Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}