Renal CancerKIDNEY-PAGERNCT06145139
KIDNEY-PAGER: Analysis of Circulating Tumor DNA as a Biomarker in Renal Cancer - an Observational Trial
An observational study of Renal Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
The overall aim of this observational study is to confirm that circulating tumor DNA (ctDNA) detected in plasma and or urine after intended curative treatment for renal cell carcinoma (RCC) can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2023to 1 Jun 2033
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 treated with curative intent for kidney cancer at Aarhus University Hospital, Denmark.
Who may be able to join
- Patients diagnosed with a locoregional cancer in the kidney, and with a tumour available for surgical excision, and sufficient performance status for surgery.
- Patients with M1 disease, but no evidence of disease after surgery and local treatment of the metastases.
- Core needle biopsy-proven renal cell carcinoma - all histologic subtypes acceptable, clinical tumour stage I-IV
- Patients 18 years or older
- Patients able to understand and sign written informed consent
- Scheduled for curative intent resectional surgery (partial or radical nephrectomy)
Who cannot join
- Patients with local disease who are not being offered a nephrectomy.
- Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits and/or otherwise considered by the Investigator to be unlikely to complete the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: KIDNEY-PAGER: Analysis of Circulating Tumor DNA as a Biomarker in Renal Cancer
The overall aim of this observational study is to confirm that circulating tumor DNA (ctDNA) detected in plasma and or urine after intended curative treatment for renal cell carcinoma (RCC) can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence.
Read the detailed description
OBJECTIVES
The overall objective of the study is to confirm that circulating tumor DNA (ctDNA) detected in plasma and or urine after intended curative treatment for RCC can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence.
1.1 Primary objectives
- To confirm that patients with high risk of recurrence can be identified with ctDNA profiling performed immediately after nephrectomy. Specifically, we aim to determine in patients with localized RCC (stages I-III) if the three-year disease-free survival is associated with detection of ctDNA in plasma immediately after surgery. 1.2 Secondary objectives
- To show that detection of ctDNA pre- and post-operatively can be applied as a risk stratification tool.
- To validate the potential of a ctDNA-guided follow-up program as compared to the current CT-scan follow-up program. More specifically, to investigate the correlation between ctDNA and CT-scanning findings. The potential is that ctDNA analysis predicts the CT-scan result and can be used to guide when to perform a CT-scan. Potentially, it also adds evidence for the results of CT-scans performed subsequently to an uncertain CT-scan result.
- To investigate if time to Molecular recurrence using serial ctDNA analysis of longitudinally collected blood samples is shorter than time to Clinical recurrence using standard-of-care radiological imaging surveillance.
- To find and validate predictive blood- and or tissue-based biomarkers for immunotherapy and or targeted therapies with the aim to identify patients that are more likely to respond to the given therapy administered.
- To confirm that changes in ctDNA levels reflect the therapeutic effect of the given therapy, such as immunotherapy and or targeted therapies.
- To delineate markers of tumor aggressiveness and compare to ctDNA measurements
2 INVESTIGATIONAL PLAN
2.1 Overall study design
This study is based on a comprehensive series of blood sampling prospectively and ctDNA analysis performed in RCC patients before and after surgery, during and after treatment, and during surveillance. Patients are followed 5 years from date of surgery.
- Urine, blood sampling and ctDNA analysis pre-operative and immediately after surgery (a postoperative blood sample is drawn on day 14)
- Sampling of tissue from the biopsy and resected specimen as well as adjacent normal.
- Longitudinal blood and urine sampling over a 5-year surveillance period - a blood and urine sample will be drawn simultaneously with the standard-of-care CT-scan-based surveillance program, and from metastatic tissue if a relapse occurs.
- Conditions
- Renal Cancer
- Keywords
- circulating tumor dna
- Medical subject headings
- Kidney Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA can identify high risk patients
ctDNA will be determined and levels will be measured, and correlated to relapse status, progression free survival, treatment response and overall survival
Measured: baseline, 1 year, 2 year and 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145139
- Sponsor's protocol ID
- 1-16-02-476-22
- Acronym
- KIDNEY-PAGER
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KIDNEY-PAGER: Analysis of Circulating Tumor DNA as a Biomarker in Renal Cancer
- ClinicalTrials.gov ID
- NCT06145139
- Acronym / sponsor ID
- KIDNEY-PAGER / 1-16-02-476-22
- Conditions
- Renal Cancer
- Keywords
- circulating tumor dna
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2033 (estimated)
- First posted
- 22 Nov 2023 (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.
The overall aim of this observational study is to confirm that circulating tumor DNA (ctDNA) detected in plasma and or urine after intended curative treatment for renal cell carcinoma (RCC) can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence.
Detailed description
OBJECTIVES
The overall objective of the study is to confirm that circulating tumor DNA (ctDNA) detected in plasma and or urine after intended curative treatment for RCC can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence.
1.1 Primary objectives
- To confirm that patients with high risk of recurrence can be identified with ctDNA profiling performed immediately after nephrectomy. Specifically, we aim to determine in patients with localized RCC (stages I-III) if the three-year disease-free survival is associated with detection of ctDNA in plasma immediately after surgery. 1.2 Secondary objectives
- To show that detection of ctDNA pre- and post-operatively can be applied as a risk stratification tool.
- To validate the potential of a ctDNA-guided follow-up program as compared to the current CT-scan follow-up program. More specifically, to investigate the correlation between ctDNA and CT-scanning findings. The potential is that ctDNA analysis predicts the CT-scan result and can be used to guide when to perform a CT-scan. Potentially, it also adds evidence for the results of CT-scans performed subsequently to an uncertain CT-scan result.
- To investigate if time to Molecular recurrence using serial ctDNA analysis of longitudinally collected blood samples is shorter than time to Clinical recurrence using standard-of-care radiological imaging surveillance.
- To find and validate predictive blood- and or tissue-based biomarkers for immunotherapy and or targeted therapies with the aim to identify patients that are more likely to respond to the given therapy administered.
- To confirm that changes in ctDNA levels reflect the therapeutic effect of the given therapy, such as immunotherapy and or targeted therapies.
- To delineate markers of tumor aggressiveness and compare to ctDNA measurements
2 INVESTIGATIONAL PLAN
2.1 Overall study design
This study is based on a comprehensive series of blood sampling prospectively and ctDNA analysis performed in RCC patients before and after surgery, during and after treatment, and during surveillance. Patients are followed 5 years from date of surgery.
- Urine, blood sampling and ctDNA analysis pre-operative and immediately after surgery (a postoperative blood sample is drawn on day 14)
- Sampling of tissue from the biopsy and resected specimen as well as adjacent normal.
- Longitudinal blood and urine sampling over a 5-year surveillance period - a blood and urine sample will be drawn simultaneously with the standard-of-care CT-scan-based surveillance program, and from metastatic tissue if a relapse occurs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with curative intent for kidney cancer at Aarhus University Hospital, Denmark.
Key inclusion criteria (6 listed)
- Patients diagnosed with a locoregional cancer in the kidney, and with a tumour available for surgical excision, and sufficient performance status for surgery.
- Patients with M1 disease, but no evidence of disease after surgery and local treatment of the metastases.
- Core needle biopsy-proven renal cell carcinoma - all histologic subtypes acceptable, clinical tumour stage I-IV
- Patients 18 years or older
- Patients able to understand and sign written informed consent
Key exclusion criteria (2 listed)
- Patients with local disease who are not being offered a nephrectomy.
- Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits and/or otherwise considered by the Investigator to be unlikely to complete the study
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
ctDNA can identify high risk patients
Time frame: baseline, 1 year, 2 year and 3 year
ctDNA will be determined and levels will be measured, and correlated to relapse status, progression free survival, treatment response and overall survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Cancer, run by University of Aarhus at 1 site in Denmark.
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 6 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 22 Nov 2023. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
ctDNA can identify high risk patients (time frame: baseline, 1 year, 2 year and 3 year). 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 Nov 2023.