Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT07161167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in Body Composition of Patients With Obesity Related Tumors and Their Impact on Clinical Outcomes: a Multicenter Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6743}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From date of diagnosis until the date of death from any cause, assessed up to 10 years', 'description': 'The time from the start of follow-up to death (for any reason).'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival after diagnosis', 'timeFrame': 'From date of diagnosis until the date of first documented progression , assessed up to 10 years'}, {'measure': 'Time of recurrence and/or distant metastasis after diagnosis', 'timeFrame': 'From date of diagnosis until the date of first documented recurrence and/or distant metastasis, whichever came first, assessed up to 10 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity Rekated Cancer', 'Body Composition Changes', 'Survival', 'Mechanism']}, 'descriptionModule': {'briefSummary': "Over the past 20 years, China's obesity rates have surged, increasing cancer burden. Obesity links to 13 cancers via metabolic effects of visceral fat and insulin resistance, while sarcopenic obesity (BMI-independent) may worsen outcomes. Traditional BMI lacks precision; advanced methods (e.g., BIA/CT) are needed. Existing studies show inconsistent results, possibly due to heterogeneity. This multicenter prospective cohort study uses imaging to assess body composition changes (fat/muscle) in obesity-related tumors and their impact on survival, recurrence, and quality of life, and explore the underlying mechanism."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will be enrolled if they are under clinical care in oncology-related departments', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender.\n2. Histologically or cytologically confirmed obesity-associated malignant tumors (e.g., breast cancer, colorectal cancer, gastric cancer, lung cancer, or thyroid cancer) with planned treatment after diagnosis (any treatment modality permitted).\n3. No prior chemotherapy, radiotherapy, biologic therapy, immunotherapy, or other antitumor treatments for malignancy.\n\nExclusion Criteria:\n\n1. Patients with concurrent non-obesity-related malignancies.\n2. History of prior malignancy (except completely cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin).\n3. Patients with concurrent multiorgan dysfunction syndrome, autoimmune diseases, infectious diseases, neurological disorders, or psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT07161167', 'briefTitle': 'Changes in Body Composition of Patients With Obesity Related Tumors and Their Impact on Clinical Outcomes: a Multicenter Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Changes in Body Composition of Patients With Obesity Related Tumors and Their Impact on Clinical Outcomes: a Multicenter Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'obesity-related cancer & BC'}}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Dr.Yu', 'role': 'CONTACT', 'email': 'yuk1997@sina.com', 'phone': '+86-10-69155550'}], 'facility': 'Peking union medical college hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}