Clinical trial NCT06898632: KidneyCare Cohort Study (KCC-S)
Official title: KidneyCare Cohort Study: Biologic Interrogation of Sarcopenia in Patients With Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Kidney Cancer
Keywords: Health Behaviors
Treatment
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to clinic 2B at the Huntsman Cancer Hospital

Brief summary: 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.

Detailed description: If patients decide to participate in this study, they will be asked to complete the following assessments:

Health 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.

Follow-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.

Performance 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).

Blood 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.

Urine samples: A urine sample will be requested at baseline and again about 12 months later.

Stool Samples: A stool sample will be requested at baseline and again about 12 months later.

Tissue 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.

Medical 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.

Eligibility criteria: Inclusion Criteria:

* Renal Cell Cancer (RCC) stage I-IV
* Undergoing radical nephrectomy (entire kidney resection) or partial nephrectomy
* Patients with or without prior systemic therapy for renal cell carcinoma and \> 1 year from systemic therapy for other non-cutaneous malignancy
* Cytoreductive nephrectomy (nephrectomy in the setting of limited metastatic disease)

Exclusion Criteria:

* Does not consent to tissue collection
* Patients with only an MRI abdomen/pelvis within 4 months of surgery will be excluded
* Known biopsy-proven non-clear cell RCC

Primary outcomes:
measure: Percent of Scheduled Assessments Completed
timeFrame: End of Participation (60-months post-surgery)
Secondary outcomes:
measure: Change in Muscle Mass
timeFrame: Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.
measure: Change in Visceral Fat
timeFrame: Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.
measure: Change in Functional Status
timeFrame: Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: University of Utah
name: Alejandro Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
References: