Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:55 AM
Study NCT ID:
NCT07412158
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Clinical Application of a Novel Imaging Grading System for Pheochromocytoma and Paraganglioma (PPGL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010673', 'term': 'Pheochromocytoma'}, {'id': 'D010235', 'term': 'Paraganglioma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': 'Intraoperative'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Risk Grading System', 'Pheochromocytoma and Paraganglioma (PPGL)', 'Quantitative Assessment']}, 'descriptionModule': {'briefSummary': 'This study aims to develop and preliminarily validate an anatomy-morphological risk grading system (IUPU-PPGL Grading) based on preoperative imaging 3D reconstruction, in order to quantitatively assess surgical complexity and perioperative safety in PPGL patients, and to evaluate the value of this grading system for formulating individualized surgical strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent surgical resection and were definitively diagnosed with pheochromocytoma or paraganglioma (PPGL) by postoperative pathology at Peking University First Hospital between January 1, 2017 and December 31, 2025 were included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ① Patients who underwent curative surgical resection (including laparoscopic, robot-assisted, or open surgery) at our hospital within the study period;\n\n * Postoperative pathological confirmation of PPGL;\n\n * Availability of complete preoperative imaging data; ④ Availability of complete perioperative clinical data, including anesthesia records, surgical records, and postoperative hospitalization information; ⑤ Age ≥ 18 years.\n\nExclusion Criteria:\n\n* ① Lack of key imaging data or poor image quality that could not meet evaluation requirements;\n\n * Requirement for concurrent complex surgery for other diseases, making it difficult to independently assess perioperative indicators; ③ History of biopsy only, exploratory surgery, or presence of recurrence, bilateral, or multifocal lesions, preventing independent evaluation; ④ Primary tumors located in special sites (e.g., pelvic, bladder, spermatic cord, or other rare extra-adrenal locations), leading to incomparable surgical approaches and perioperative outcomes.'}, 'identificationModule': {'nctId': 'NCT07412158', 'briefTitle': 'Development and Clinical Application of a Novel Imaging Grading System for Pheochromocytoma and Paraganglioma (PPGL)', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Development and Clinical Application of a Novel Imaging Grading System for Pheochromocytoma and Paraganglioma (PPGL)', 'orgStudyIdInfo': {'id': 'PKU-PPGL-IMG-2025-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observational diagnostic model development', 'type': 'OTHER', 'description': 'observational diagnostic model development'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Department of Urology, Peking University First Hospital, Beijing, 100034', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}