Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT06898632
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2022-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
KidneyCare Cohort Study (KCC-S)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood: The blood samples will be drawn by a phlebotomist, research nurse, or trained study personnel. A total of 4 tablespoons of blood will be taken during each blood draw.\n\nUrine: Participants will take a cup into the restroom and fill it about ¾ full with urine.\n\nStool: Participants will be provided with a stool collection kit, instructions, mailing containers, and a sample form. The stool sample can be collected at home, frozen, and mailed to Huntsman Cancer Institute (HCI) or delivered in person.\n\nTissue: Samples of tumor, normal kidney, and fat tissue which surrounds the kidney will be obtained. Fat tissue under the skin, omentum (fat apron that drapes over the abdomen) and muscle tissue from one of the existing incision sites will also be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-01-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2022-09-08', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Scheduled Assessments Completed', 'timeFrame': 'End of Participation (60-months post-surgery)', 'description': 'Feasibility of the study will be assessed by calculating a percentage of scheduled body composition, performance status measurements, performance status questionnaires and biospecimen collections completed.'}], 'secondaryOutcomes': [{'measure': 'Change in Muscle Mass', 'timeFrame': 'Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.', 'description': 'Using CT-derived body composition analysis, we will assess the mean change in skeletal muscle mass from the pre-operative baseline through 60-months post-surgery.'}, {'measure': 'Change in Visceral Fat', 'timeFrame': 'Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.', 'description': 'Using CT-derived body composition analysis, we will assess the mean change in visceral fat area from the pre-operative baseline through 60-months post-surgery.'}, {'measure': 'Change in Functional Status', 'timeFrame': 'Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.', 'description': 'Functional status will be assessed using mean change in handgrip strength measured by hand-held dynamometer from the pre-operative baseline through 60-months post-surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Behaviors', 'Treatment'], 'conditions': ['Kidney Cancer']}, 'descriptionModule': {'briefSummary': "This research study aims to learn how lifestyle factors (e.g., obesity) impact the risk of developing kidney cancer and impact survival after nephrectomy (removal of a kidney). The study team's long-term goals are to learn: 1) How to improve treatment success in future patients by tailoring therapies to each patient's unique biology; and 2) What future patients can do to improve their health after diagnosis. To this end, the study team will collect samples (such as blood and extra tissue from surgery) from patients and store and test these samples. The study team also asks patients about their health behaviors (e.g., diet and physical activity) and well-being before their diagnosis and afterwards by filling out questionnaires.", 'detailedDescription': "If patients decide to participate in this study, they will be asked to complete the following assessments:\n\nHealth questionnaires: The study team will ask participants to complete this health questionnaire within two weeks before their surgery. The questionnaire will ask information about medical history and health-related behaviors.\n\nFollow-up questionnaires: After participants undergo surgery, the study team will contact participants periodically to ask questions about any symptoms they may be experiencing, as well as current physical activity, diet, and quality of life (this will take about 60 minutes to complete). The study team will contact participants with additional questionnaires about 3-6 months post-surgery, 12 months, 24 months, and 60 months later to learn how to improve cancer treatment and overall health after diagnosis for kidney cancer patients.\n\nPerformance status assessments: Various measurements of performance status such as handgrip strength, time up \\& go test, 6-min walk test, and 30-second chair stand will be taken prior to surgery and during follow-up visits (3-6 months and 12 months).\n\nBlood samples: A blood sample will be requested at baseline, as well as at standard of care follow-up visits about 3-6 months and 12 months later during standard follow-up appointments. The study team will request blood samples again at approximately 2 years and 5 years post-surgery.\n\nUrine samples: A urine sample will be requested at baseline and again about 12 months later.\n\nStool Samples: A stool sample will be requested at baseline and again about 12 months later.\n\nTissue samples: During kidney surgery, surgeons remove the cancerous tissue. A portion of the tissues will be used by doctors to further understand participants' treatment needs. If there is extra tissue available, the study team asks to obtain samples of tumor, normal kidney, and fat tissue which surrounds the kidney and is usually removed with the surgical specimen. Only tissue that the pathologists decide is not needed for your diagnosis will be used by the study. The study team also asks for permission to collect fat tissue under the skin (subcutaneous), omentum (fat apron that drapes over your abdomen) and muscle tissue from one of the existing incision sites.\n\nMedical records: Participants will also be asked to give study staff permission to copy and review medical records about cancer diagnosis, treatment, and future health as it pertains to participants' cancer prognosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to clinic 2B at the Huntsman Cancer Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Renal Cell Cancer (RCC) stage I-IV\n* Undergoing radical nephrectomy (entire kidney resection) or partial nephrectomy\n* Patients with or without prior systemic therapy for renal cell carcinoma and \\> 1 year from systemic therapy for other non-cutaneous malignancy\n* Cytoreductive nephrectomy (nephrectomy in the setting of limited metastatic disease)\n\nExclusion Criteria:\n\n* Does not consent to tissue collection\n* Patients with only an MRI abdomen/pelvis within 4 months of surgery will be excluded\n* Known biopsy-proven non-clear cell RCC'}, 'identificationModule': {'nctId': 'NCT06898632', 'acronym': 'KCC-S', 'briefTitle': 'KidneyCare Cohort Study (KCC-S)', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'KidneyCare Cohort Study: Biologic Interrogation of Sarcopenia in Patients With Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'HCI133144'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': '* Will provide blood, urine, and stool samples as well as CT-derived body composition and performance status assessments during the baseline and follow-up study visits.\n* Will provide tissue samples (kidney, fat, omentum, muscle) during cancer surgery.\n* Will provide follow-up questionnaires.'}, {'label': 'Cohort 2', 'description': '* Will provide blood, urine, and stool samples as well as CT-derived body composition during the baseline study visit.\n* Will provide tissue samples (kidney, fat, omentum, muscle) during cancer surgery.\n* Will provide CT-derived body composition during follow-up.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Alejandro Sanchez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}