Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT04952103
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2021-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real World Study of Diagnosis and First-line Treatment Among Patients With Cancer of Unknown Primary in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009382', 'term': 'Neoplasms, Unknown Primary'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2024-06-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer of Unknown Primary Site']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, real world study.The objective is to observe the diagnosis and first-line treatment of Chinese patients with cancer of unknown primary, and collect the clinicopathological characteristics, treatment outcomes, survival and other data of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cancer of unknown primary (CUP) and are gonging to receive the first-line therapy for CUP', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had a diagnosis of cancer of unknown primary (CUP) after a standard evaluation .\n* Prepared to receive first-line therapy for CUP\n\nExclusion Criteria:\n\n* Patients who had previously received systemic therapy for CUP\n* Previous history of other cancers, except cervix cancer or basal cell carcinoma of the skin that has been cured\n* The investigator considered that there were contraindications to treatment or were not appropriate to participate in this study'}, 'identificationModule': {'nctId': 'NCT04952103', 'briefTitle': 'Real World Study of Diagnosis and First-line Treatment Among Patients With Cancer of Unknown Primary in China', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Real World Study of Diagnosis and First-line Treatment Among Patients With Cancer of Unknown Primary in China', 'orgStudyIdInfo': {'id': 'Fudan-CUP-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': "The patient's treatment is determined by the physician in charge according to the patient's clinical situation and relevant guidelines, without additional intervention."}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiguo Luo, MD,PhD', 'role': 'CONTACT', 'email': 'luozhiguo88@163.com', 'phone': '862164175590', 'phoneExt': '8908'}], 'facility': 'Fudan University Shanghai Cencer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xin Liu', 'role': 'CONTACT', 'email': 'jeanettexin@hotmail.com', 'phone': '13761503356'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhiguo Luo, MD, PhD', 'investigatorAffiliation': 'Fudan University'}}}}