NCT06794567Not yet recruiting
Genomic First Testing in Chronic Kidney Disease
Improving Diagnosis for Genetic Kidney Disease Through Early Genomic Assessment
Source: ClinicalTrials.gov · Last updated 27 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This multi-center study examines the role of genetic testing in patients with chronic kidney disease (CKD) who are identified as being at risk for genetic kidney disease, based on Ontario Health's Provincial Genetic Program (OH-PGP) guidelines. Participants will be assigned to either genome-wide sequencing or standard genetic testing, depending on when they were initially diagnosed with kidney disease. To evaluate the impact of genetic testing, patients and caregivers will complete quality-of-life questionnaires before and after testing. Participants may also choose to take part in a one-on-one interview at the end of the study to provide additional insights. They will have the option to link their data to the Institute for Clinical Evaluative Sciences (ICES), allowing researchers to explore health outcomes such as the costs of genetic testing and healthcare resource use. Family members of participants will be invited to provide DNA samples to help identify genetic changes in the affected individual. Referring physicians will complete a survey to assess the clinical value of genetic testing for each patient they refer. We will perform an economic analysis comparing the genome wide sequencing to the standard genetic testing group. The study's findings will offer important guidance on how genetic testing influences patient care, clinical outcomes, and the timing of genomic assessments in managing CKD.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 2400 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Dervla Connaughton
- Diseases
- Chronic kidney disease
- NCT number
- NCT06794567
What you commit to
- Study type: Observational
- Planned participants: 2400
- From 1 Mar 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- \<18 years of age unless the guardian can conduct the interview
Other
- Participant or SDM is unable to provide consent, for any reason, to be an unsuitable candidate for the study.
- Fail screening as set out by the Provincial Genetics Program Eligibility Criteria for genetic assessment in CKD.
- Family Members:
- Family/caregiver or SDM is unable to provide consent, for any reason, to be an unsuitable candidate for the study.
- Related patient participant is not enrolled in the study.
- Healthcare Provider:
- 1\. Is not a referring healthcare provider.
- Qualitative Sub-Study:
- Patient participant who is not enrolled in the main study.
Who the study is looking for
- A diagnosis of CKD warranting a referral to a nephrologist for further assessment AND
- Screen positive for potential genetic kidney disease using the Ontario Health Provincial Genetics Program Eligibility Criteria for genetic assessment in CKD AND
- Index participant or substitute decision maker (SDM) can provide informed consent to participate.
- Family/caregiver or SDM can provide informed consent to participate AND
- Related patient participant must be enrolled in the study.
- Patient participant who is enrolled in the main study.
- 18 years or older.
- The guardian for a minor
Criteria the registry did not label
- Patients:
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.