Kidney CancerNCT03414827
Genetic Evaluation of Renal Cell Carcinoma; Predicting Biomarkers for Renal Cell Carcinoma
An observational study of Kidney Cancer, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Recruitment of participants to the study takes place at the urological department at Zealand University Hospital, Roskilde, Feb. 2018-April 2018. 10 people with diagnosis of renal cancer should be recruited in phases 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Cancer
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2019to 1 Dec 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Patients who have been diagnosed with kidney cancer and found suitable for inclusion will be included in the project. * The biological material has been collected during routine treatment. * Biological material has not been collected in connection with a previous study.
Who may be able to join
- Patients who have been diagnosed with kidney cancer.
Who cannot join
- Patients without signs of malignancy at final histology report.
- Incapacitated patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Roskilde, 4000
Nessn H. Azawi, M.D., 004526393034, nesa@regionsjaelland.dk
Nessn Azawi, Ph.D
About this study
Recruitment of participants to the study takes place at the urological department at Zealand University Hospital, Roskilde, Feb. 2018-April 2018. 10 people with diagnosis of renal cancer should be recruited in phases 1. Subsequently, biological materials from 100 patients with kidney cancer will be used from the national Biobank. In phase 3, 10 patients will be recruited for the final gene test.
- Conditions
- Kidney Cancer
- Medical subject headings
- Kidney Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA
Sequence variation in specific genes
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Feb 2019
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessn Azawi, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414827
- Sponsor's protocol ID
- SJ-608
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2018
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.
PubMed 32203306
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Evaluation of Renal Cell Carcinoma; Predicting Biomarkers for Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03414827
- Acronym / sponsor ID
- SJ-608
- Conditions
- Kidney Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Jan 2018 (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.
Recruitment of participants to the study takes place at the urological department at Zealand University Hospital, Roskilde, Feb. 2018-April 2018. 10 people with diagnosis of renal cancer should be recruited in phases 1. Subsequently, biological materials from 100 patients with kidney cancer will be used from the national Biobank. In phase 3, 10 patients will be recruited for the final gene test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patients who have been diagnosed with kidney cancer and found suitable for inclusion will be included in the project. * The biological material has been collected during routine treatment. * Biological material has not been collected in connection with a previous study.
Key inclusion criteria (1 listed)
- Patients who have been diagnosed with kidney cancer.
Key exclusion criteria (2 listed)
- Patients without signs of malignancy at final histology report.
- Incapacitated patients.
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
DNA
Time frame: 30 days
Sequence variation in specific genes
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 30 Jan 2024.
- Derived from this study: PubMed 32203306Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.
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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.
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 Zealand University Hospital 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 1 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: looking for participants now, as of the sponsor's last update on 30 Jan 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03414827, which also lists 1 linked publication.
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 30 Jan 2024.