Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-24 @ 12:07 PM
Study NCT ID:
NCT04278261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-06-02
First Post:
2020-02-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 216}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urinary function measured by ICIQ', 'timeFrame': '4 weeks', 'description': 'The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score'}, {'measure': 'urinary function measured by ICIQ', 'timeFrame': '6 weeks', 'description': 'The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score'}, {'measure': 'urinary function measured by ICIQ', 'timeFrame': '12 weeks', 'description': 'The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score'}, {'measure': 'urinary function measured by ICIQ', 'timeFrame': '6 months', 'description': 'The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score'}, {'measure': 'urinary function measured by ICIQ', 'timeFrame': '12 months', 'description': 'The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score'}, {'measure': 'urinary function measured by ICIQ', 'timeFrame': '24 months', 'description': 'The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score'}, {'measure': 'urinary function measured by EPIC', 'timeFrame': '4 weeks', 'description': 'The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score'}, {'measure': 'urinary function measured by EPIC', 'timeFrame': '6 weeks', 'description': 'The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score'}, {'measure': 'urinary function measured by EPIC', 'timeFrame': '12 weeks', 'description': 'The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score'}, {'measure': 'urinary function measured by EPIC', 'timeFrame': '6 months', 'description': 'The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score'}, {'measure': 'urinary function measured by EPIC', 'timeFrame': '12 months', 'description': 'The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score'}, {'measure': 'urinary function measured by EPIC', 'timeFrame': '24 months', 'description': 'The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score'}, {'measure': 'urinary function measured by separate EPIC pad-use item', 'timeFrame': '4 weeks', 'description': 'The urinary function will be measured by a separate EPIC pad-use item'}, {'measure': 'urinary function measured by separate EPIC pad-use item', 'timeFrame': '6 weeks', 'description': 'The urinary function will be measured by a separate EPIC pad-use item'}, {'measure': 'urinary function measured by separate EPIC pad-use item', 'timeFrame': '12 weeks', 'description': 'The urinary function will be measured by a separate EPIC pad-use item'}, {'measure': 'urinary function measured by separate EPIC pad-use item', 'timeFrame': '6 months', 'description': 'The urinary function will be measured by a separate EPIC pad-use item'}, {'measure': 'urinary function measured by separate EPIC pad-use item', 'timeFrame': '12 months', 'description': 'The urinary function will be measured by a separate EPIC pad-use item'}, {'measure': 'urinary function measured by separate EPIC pad-use item', 'timeFrame': '24 months', 'description': 'The urinary function will be measured by a separate EPIC pad-use item'}, {'measure': 'urinary function measured by IPSS', 'timeFrame': '4 weeks', 'description': 'The urinary function will be measured by IPSS (International Prostate Symptom Score)'}, {'measure': 'urinary function measured by IPSS', 'timeFrame': '6 weeks', 'description': 'The urinary function will be measured by IPSS (International Prostate Symptom Score)'}, {'measure': 'urinary function measured by IPSS', 'timeFrame': '12 weeks', 'description': 'The urinary function will be measured by IPSS (International Prostate Symptom Score)'}, {'measure': 'urinary function measured by IPSS', 'timeFrame': '6 months', 'description': 'The urinary function will be measured by IPSS (International Prostate Symptom Score)'}, {'measure': 'urinary function measured by IPSS', 'timeFrame': '12 months', 'description': 'The urinary function will be measured by IPSS (International Prostate Symptom Score)'}, {'measure': 'urinary function measured by IPSS', 'timeFrame': '24 months', 'description': 'The urinary function will be measured by IPSS (International Prostate Symptom Score)'}, {'measure': 'sexual function measured by EPIC', 'timeFrame': '4 weeks', 'description': 'The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score'}, {'measure': 'sexual function measured by EPIC', 'timeFrame': '6 weeks', 'description': 'The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score'}, {'measure': 'sexual function measured by EPIC', 'timeFrame': '12 weeks', 'description': 'The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score'}, {'measure': 'sexual function measured by EPIC', 'timeFrame': '6 months', 'description': 'The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score'}, {'measure': 'sexual function measured by EPIC', 'timeFrame': '12 months', 'description': 'The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score'}, {'measure': 'sexual function measured by EPIC', 'timeFrame': '24 months', 'description': 'The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score'}, {'measure': 'sexual function measured by IIEF-5', 'timeFrame': '4 weeks', 'description': 'The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)'}, {'measure': 'sexual function measured by IIEF-5', 'timeFrame': '6 weeks', 'description': 'The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)'}, {'measure': 'sexual function measured by IIEF-5', 'timeFrame': '12 weeks', 'description': 'The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)'}, {'measure': 'sexual function measured by IIEF-5', 'timeFrame': '6 months', 'description': 'The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)'}, {'measure': 'sexual function measured by IIEF-5', 'timeFrame': '12 months', 'description': 'The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)'}, {'measure': 'sexual function measured by IIEF-5', 'timeFrame': '24 months', 'description': 'The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)'}], 'secondaryOutcomes': [{'measure': 'Number of patients with Disease progression', 'timeFrame': '24 months', 'description': 'is defined either of the following items: (1) clinical evidence of progression (any of the positive results from the bone scan, pelvic MRI/CT, PSMA-PET MR/CT); (2) a positive biopsy (for the H-FIRE arm only); (3) biochemical failure (BCR, for the RP arm only, defined as a serum PSA level higher than 0.4 ng/ml after surgery)'}, {'measure': 'Bowel function', 'timeFrame': '4 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score'}, {'measure': 'Bowel function', 'timeFrame': '6 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score'}, {'measure': 'Bowel function', 'timeFrame': '12 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score'}, {'measure': 'Bowel function', 'timeFrame': '6 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score'}, {'measure': 'Bowel function', 'timeFrame': '12 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score'}, {'measure': 'Bowel function', 'timeFrame': '24 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score'}, {'measure': 'Quality of life measure by EORTC QLQ-C30', 'timeFrame': '4 weeks', 'description': 'measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)'}, {'measure': 'Quality of life measure by EORTC QLQ-C30', 'timeFrame': '6 weeks', 'description': 'measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)'}, {'measure': 'Quality of life measure by EORTC QLQ-C30', 'timeFrame': '12 weeks', 'description': 'measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)'}, {'measure': 'Quality of life measure by EORTC QLQ-C30', 'timeFrame': '6 months', 'description': 'measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)'}, {'measure': 'Quality of life measure by EORTC QLQ-C30', 'timeFrame': '12 months', 'description': 'measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)'}, {'measure': 'Quality of life measure by EORTC QLQ-C30', 'timeFrame': '24 months', 'description': 'measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)'}, {'measure': 'Quality of life measure by EPIC urinary domain bother score', 'timeFrame': '4 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score'}, {'measure': 'Quality of life measure by EPIC urinary domain bother score', 'timeFrame': '6 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score'}, {'measure': 'Quality of life measure by EPIC urinary domain bother score', 'timeFrame': '12 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score'}, {'measure': 'Quality of life measure by EPIC urinary domain bother score', 'timeFrame': '6 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score'}, {'measure': 'Quality of life measure by EPIC urinary domain bother score', 'timeFrame': '12 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score'}, {'measure': 'Quality of life measure by EPIC urinary domain bother score', 'timeFrame': '24 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score'}, {'measure': 'Quality of life measure by EPIC sexual domain bother score', 'timeFrame': '4 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score'}, {'measure': 'Quality of life measure by EPIC sexual domain bother score', 'timeFrame': '6 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score'}, {'measure': 'Quality of life measure by EPIC sexual domain bother score', 'timeFrame': '12 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score'}, {'measure': 'Quality of life measure by EPIC sexual domain bother score', 'timeFrame': '6 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score'}, {'measure': 'Quality of life measure by EPIC sexual domain bother score', 'timeFrame': '12 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score'}, {'measure': 'Quality of life measure by EPIC sexual domain bother score', 'timeFrame': '24 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score'}, {'measure': 'Quality of life measure by EPIC bowel domain bother score', 'timeFrame': '4 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score'}, {'measure': 'Quality of life measure by EPIC bowel domain bother score', 'timeFrame': '6 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score'}, {'measure': 'Quality of life measure by EPIC bowel domain bother score', 'timeFrame': '12 weeks', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score'}, {'measure': 'Quality of life measure by EPIC bowel domain bother score', 'timeFrame': '6 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score'}, {'measure': 'Quality of life measure by EPIC bowel domain bother score', 'timeFrame': '12 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score'}, {'measure': 'Quality of life measure by EPIC bowel domain bother score', 'timeFrame': '24 months', 'description': 'measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score'}, {'measure': 'Quality of life measure by HADS', 'timeFrame': '4 weeks', 'description': 'measured by Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Quality of life measure by HADS', 'timeFrame': '6 weeks', 'description': 'measured by Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Quality of life measure by HADS', 'timeFrame': '12 weeks', 'description': 'measured by Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Quality of life measure by HADS', 'timeFrame': '6 months', 'description': 'measured by Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Quality of life measure by HADS', 'timeFrame': '12 months', 'description': 'measured by Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Quality of life measure by HADS', 'timeFrame': '24 months', 'description': 'measured by Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Rates of primary treatment failure', 'timeFrame': '24 months', 'description': 'defined as biopsy show cancer remain at 6 months after H-FIRE procedure, or a PSA level 0.4ng/ml or higher at 3 months after RP procedure'}, {'measure': 'Rates of adjuvant therapy', 'timeFrame': '4 weeks', 'description': 'defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery'}, {'measure': 'Rates of adjuvant therapy', 'timeFrame': '6 weeks', 'description': 'defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery'}, {'measure': 'Rates of adjuvant therapy', 'timeFrame': '12 weeks', 'description': 'defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery'}, {'measure': 'Rates of adjuvant therapy', 'timeFrame': '6 months', 'description': 'defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery'}, {'measure': 'Rates of adjuvant therapy', 'timeFrame': '12 months', 'description': 'defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery'}, {'measure': 'Rates of adjuvant therapy', 'timeFrame': '24 months', 'description': 'defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery'}, {'measure': 'Perioperative data (operative time)', 'timeFrame': '1 month', 'description': 'operative time'}, {'measure': 'Perioperative data (hemoglobin loss)', 'timeFrame': '1 month', 'description': 'hemoglobin loss'}, {'measure': 'Perioperative data (blood transfusion)', 'timeFrame': '1 month', 'description': 'the number of patients need blood transfusion'}, {'measure': 'Perioperative data (the length of hospital stay)', 'timeFrame': '1 month', 'description': 'the length of hospital stay'}, {'measure': 'Perioperative data(the length of indwelling catheter stay)', 'timeFrame': '1 month', 'description': 'the length of indwelling catheter stay'}, {'measure': 'Pain (measured by a surgical pain scale range from 0 to 10)', 'timeFrame': '24 hours', 'description': 'measured by a surgical pain scale range from 0 to 10'}, {'measure': 'Pain (measured by a surgical pain scale range from 0 to 10)', 'timeFrame': '2 weeks', 'description': 'measured by a surgical pain scale range from 0 to 10'}, {'measure': 'Pain (measured by a surgical pain scale range from 0 to 10)', 'timeFrame': '4 weeks', 'description': 'measured by a surgical pain scale range from 0 to 10'}, {'measure': 'Pain (measured by a surgical pain scale range from 0 to 10)', 'timeFrame': '6 weeks', 'description': 'measured by a surgical pain scale range from 0 to 10'}, {'measure': 'Pain (measured by a surgical pain scale range from 0 to 10)', 'timeFrame': '12 weeks', 'description': 'measured by a surgical pain scale range from 0 to 10'}, {'measure': 'Pain (measured by a surgical pain scale range from 0 to 10)', 'timeFrame': '6 months', 'description': 'measured by a surgical pain scale range from 0 to 10'}, {'measure': 'Adverse effect', 'timeFrame': '24 months', 'description': 'identified by the Common Terminology Criteria for Adverse Events (CTCAE)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Focal therapy', 'Radical prostatectomy', 'high-frequency Irreversible electroporation', 'prostate cancer'], 'conditions': ['Prostate Cancer', 'Treatment']}, 'descriptionModule': {'briefSummary': 'This trial is comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy.', 'detailedDescription': 'Two hundred and sixteen patients with localized prostate cancer will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-frequency irreversible electroporation; group 2, laparoscopic radical prostatectomy. The primary outcome is the urinary function and sexual function.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age less than 80 years old.\n2. PSA\\<20ng/ml.\n3. Clinical stage ≤T2c.\n4. Biopsy Gleason score ≤4+4.\n5. No evidence of metastasis.\n6. Fully understand the clinical trial protocol and sign the informed consent\n\nExclusion Criteria:\n\n1. Any previous treatment to PCa.\n2. Any previous surgery within 3 months.\n3. Contraindications to MRI, bone scan, or PSMA-PET (eg, metal implant, contrast agent allergy).\n4. History of any other malignant tumour.\n5. Any other conditions that make the investigator judge that participants are not suitable for this trial.'}, 'identificationModule': {'nctId': 'NCT04278261', 'briefTitle': 'Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai East Hospital'}, 'officialTitle': 'A Prospective, Single-center, Randomized Controlled Trial Comparing the Functional and Oncological Outcomes of High-frequency Irreversible Electroporation and Laparoscopic Radical Prostatectomy in Men With Localized Prostate Cancer', 'orgStudyIdInfo': {'id': 'HIRE-FR-2019001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Focal therapy', 'description': 'Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer', 'interventionNames': ['Procedure: Focal therapy(high-frequency irreversible electroporation)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radical prostatectomy', 'description': 'Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer', 'interventionNames': ['Procedure: laparoscopic radical prostatectomy']}], 'interventions': [{'name': 'Focal therapy(high-frequency irreversible electroporation)', 'type': 'PROCEDURE', 'description': 'High-frequency irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with localized prostate cancer', 'armGroupLabels': ['Focal therapy']}, {'name': 'laparoscopic radical prostatectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic radical prostatectomy', 'armGroupLabels': ['Radical prostatectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200120', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai East Hospital, Tongji University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Biming He, MD', 'role': 'CONTACT', 'email': '190589109@qq.com', 'phone': '+8615502139410'}, {'name': 'Haifeng Wang, MD', 'role': 'CONTACT', 'email': '446720864@qq.com', 'phone': '+8613681750891'}], 'overallOfficials': [{'name': 'Haifeng Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai East Hospital,Tongji University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai East Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}