Kidney CancerKCC-SNCT06898632
KidneyCare Cohort Study (KCC-S)
An observational study of Kidney Cancer, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to clinic 2B at the Huntsman Cancer Hospital
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: KidneyCare Cohort Study: Biologic Interrogation of Sarcopenia in Patients With Renal Cell Carcinoma
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.
Read the 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.
- Conditions
- Kidney Cancer
- Keywords
- Health Behaviors, Treatment
- Medical subject headings
- Kidney Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of Participation (60-months post-surgery)
Secondary outcomes (3)
Change in Muscle Mass
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.
Measured: Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.
Change in Visceral Fat
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.
Measured: Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.
Change in Functional Status
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.
Measured: Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Mar 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Sanchez, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898632
- Sponsor's protocol ID
- HCI133144
- Acronym
- KCC-S
- Status last verified
- May 2026
- First submitted
- 8 Sep 2022
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KidneyCare Cohort Study: Biologic Interrogation of Sarcopenia in Patients With Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06898632
- Acronym / sponsor ID
- KCC-S / HCI133144
- Conditions
- Kidney Cancer
- Keywords
- Health Behaviors, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to clinic 2B at the Huntsman Cancer Hospital
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of Scheduled Assessments Completed
Time frame: End of Participation (60-months post-surgery)
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.
3 secondary outcomes
Change in Muscle Mass
Time frame: Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.
Change in Visceral Fat
Time frame: Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.
Change in Functional Status
Time frame: Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Sanchez, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Scheduled Assessments Completed (time frame: End of Participation (60-months post-surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.