KidneyCare Cohort Study (KCC-S)

NCT06898632 | Completed

• 1 other identifier: HCI133144
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Cancer

Keywords

Health Behaviors; Treatment

Outcome Measures

Primary Outcomes (1)

• Percent of Scheduled Assessments Completed

  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.

  End of Participation (60-months post-surgery)

Secondary Outcomes (3)

• Change in Muscle Mass

  Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.

• Change in Visceral Fat

  Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.

• Change in Functional Status

  Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.

Study Arms (2)

Cohort 1

* 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. * Will provide tissue samples (kidney, fat, omentum, muscle) during cancer surgery. * Will provide follow-up questionnaires.

Cohort 2

* Will provide blood, urine, and stool samples as well as CT-derived body composition during the baseline study visit. * Will provide tissue samples (kidney, fat, omentum, muscle) during cancer surgery. * Will provide CT-derived body composition during follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to clinic 2B at the Huntsman Cancer Hospital

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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. Urine: Participants will take a cup into the restroom and fill it about ¾ full with urine. Stool: 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. Tissue: 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.

MeSH Terms

Conditions

Kidney Neoplasms; Health Behavior

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Alejandro Sanchez, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: March 27, 2025
• Study Start: March 1, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

US (1)