Renal Cell CarcinomaNCT04883827
Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer
An observational study of Renal Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
Trial summary
This study will assess whether DNA released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Blood collection and Urine collection
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Jan 2021to 1 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (18 year or older) with Renal Cell Carcinoma with clear cell component and receiving an IO-containing regimen or healthy volunteers (18 years or older)
Who may be able to join
- Renal Cell Carcinoma with clear cell component
- Stage IV
- Receiving IO-containing regimen
- Measurable disease per RECIST 1.1
Who cannot join
- Active cancer (exclusion criteria only for healthy patient cohort)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Tennessee Valley Health Care System
Nashville, Tennessee, 37212
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Monitoring Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer
This study will assess whether DNA released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy
Read the detailed description
Primary Objective:
- Evaluate tumor cell free (cf)DNA as a dynamic marker of response to immuno-oncology (IO) therapy
Exploratory Objective:
- Collect data on somatic mutations in cfDNA to gain insight into the biology of IO-responders and -non-responders
- Conditions
- Renal Cell Carcinoma
- Being tested
- Blood collection, Urine collection
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
20-40 mL of blood to extract cell free DNA
Urine collectionOther
up to 15 mL of urine to extract cell free DNA
| Study group | Role | What they receive |
|---|---|---|
| RCC with clear cell component | Not described Receives: Other: Blood collection; Other: Urine collection | |
| Healthy Volunteer (no longer recruiting) | Not described Receives: Other: Blood collection; Other: Urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate tumor cfDNA as a dynamic marker of response to IO therapy
Measure of changes in the amount of tumor DNA correlated with result of routine tumor imaging studies
Measured: Up to about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start6 Jan 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Scott Haake, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Scott Haake, MD, Principal investigator, Vanderbilt Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883827
- Sponsor's protocol ID
- VICC URO 2144
- Status last verified
- Oct 2024
- First submitted
- 6 May 2021
- Last updated
- 22 Oct 2024
- 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer
- ClinicalTrials.gov ID
- NCT04883827
- Acronym / sponsor ID
- VICC URO 2144
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 12 May 2021 (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 study will assess whether DNA released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy
Detailed description
Primary Objective:
- Evaluate tumor cell free (cf)DNA as a dynamic marker of response to immuno-oncology (IO) therapy
Exploratory Objective:
- Collect data on somatic mutations in cfDNA to gain insight into the biology of IO-responders and -non-responders
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RCC with clear cell component | – | Other: Blood collection, Other: Urine collection |
| Healthy Volunteer (no longer recruiting) | – | Other: Blood collection, Other: Urine collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (18 year or older) with Renal Cell Carcinoma with clear cell component and receiving an IO-containing regimen or healthy volunteers (18 years or older)
Key inclusion criteria (4 listed)
- Renal Cell Carcinoma with clear cell component
- Stage IV
- Receiving IO-containing regimen
- Measurable disease per RECIST 1.1
Key exclusion criteria (1 listed)
- Active cancer (exclusion criteria only for healthy patient cohort)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collection20-40 mL of blood to extract cell free DNA | Other | Healthy Volunteer (no longer recruiting), RCC with clear cell component |
| Urine collectionup to 15 mL of urine to extract cell free DNA | Other | Healthy Volunteer (no longer recruiting), RCC with clear cell component |
Primary outcome
Evaluate tumor cfDNA as a dynamic marker of response to IO therapy
Time frame: Up to about 2 years
Measure of changes in the amount of tumor DNA correlated with result of routine tumor imaging studies
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 22 Oct 2024.
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
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.
Scott Haake, MD principal investigator
Vanderbilt Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center at 3 sites 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 1 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 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Evaluate tumor cfDNA as a dynamic marker of response to IO therapy (time frame: Up to about 2 years). 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 22 Oct 2024.