Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05170620
Status:
UNKNOWN
Last Update Posted:
2021-12-28
First Post:
2021-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research of Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D001913', 'term': "Bowen's Disease"}], 'ancestors': [{'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-27', 'studyFirstSubmitDate': '2021-12-24', 'studyFirstSubmitQcDate': '2021-12-27', 'lastUpdatePostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological cure', 'timeFrame': 'up to at least two years', 'description': 'No squamous intraepithelial lesions found by pathological examinations.'}], 'secondaryOutcomes': [{'measure': 'HPV clearance', 'timeFrame': 'Every six months after initial treatment for at least two years', 'description': 'The results of HPV tests are negative.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laser', 'Cervical intraepithelial neoplasia', 'Vaginal intraepithelial neoplasia', 'Vulvar intraepithelial neoplasia', 'Anal intraepithelial neoplasia', 'Perianal intraepithelial neoplasia'], 'conditions': ['Squamous Intraepithelial Lesions', 'Laser Burn']}, 'descriptionModule': {'briefSummary': 'Using multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.', 'detailedDescription': 'Patients diagnosed with CIN, VaIN, VIN, AIN or PAIN are recruited with exclusion of suspicion of malignant tumors. We use multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and then follow up the patients for at least two years. By analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'genderBased': True, 'genderDescription': 'This study focus on diseases of the female reproductive system.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Had the history of sexual life.\n2. Transferred to colposcopy examination and biopsy for abnormal screening of cervical cancer, contact bleeding of cervix, recurrent discomfort of vulva or abnormal signs of lower genital and anal tract. The pathology of biopsy indicate CIN, VaIN, VIN, AIN, or PaIN.\n3. If CIN, the colposcopy manifests transformation zone-1 which means the lesion can totally be seen. However the consideration of fertility damage of resection overweighs the chance of suffering cancer.\n4. The patients can accept multiple laser ablations and colposcopy examinations and follow-up at least 2 years.\n\nExclusion Criteria:\n\n1. Patients who are suffering cancers of other systems and in treatment.\n2. Patients suffering acute inflammation of lower genital and anal tracts.\n3. The colposcopy and pathology examination suspect of cancer of lower genital and anal tract.\n4. Patients suffering severe diseases such as insufficiency of liver and kidney function, diseases of blood system and other acute infections who will get heath harm from colposcopy and laser vaporization.'}, 'identificationModule': {'nctId': 'NCT05170620', 'briefTitle': "Research of Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions", 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': "Research of Multiple Targeting CO2 Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions", 'orgStudyIdInfo': {'id': 'TJ-IRB20210134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'description': 'Patients with squamous intraepithelial lesions of the lower anogenital tracts will receive laser ablation.', 'interventionNames': ['Procedure: laser ablation']}], 'interventions': [{'name': 'laser ablation', 'type': 'PROCEDURE', 'description': 'Laser ablation will be done for the squamous intraepithelial lesions of the lower anogenital tracts.', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuang Li, Doctor', 'role': 'CONTACT', 'email': 'lee5190008@126.com', 'phone': '+86 18971625668'}, {'name': 'Dongli Kong, Doctor', 'role': 'CONTACT', 'email': 'kongdongli1988@163.com', 'phone': '+86 15107173860'}], 'facility': 'Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Shuang Li, Doctor', 'role': 'CONTACT', 'email': 'lee5190008@126.com', 'phone': '+86 18971625668'}, {'name': 'Dongli Kong, Doctor', 'role': 'CONTACT', 'email': 'kongdongli1988@163.com', 'phone': '+86 15107173860'}], 'overallOfficials': [{'name': 'Shuang Li, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}