Rare Disease Trial, By Invitation NCT06935019 Sponsor: The Hospital for Sick Children Condition: Rare Disease
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Rare Disease Trial, By Invitation

NCT06935019
By Invitation Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The patient has been referred to the Genetics Clinic at SickKids or CHEO, and that referral was accepted within 7 days of being checked for study eligibility.
  • The patient is 18 years old or younger.
  • The reason for the referral is a health condition that is suspected to be a rare disease but has not yet been diagnosed.
  • A genetic cause is considered a possible explanation for the patient's symptoms, meaning genetic testing would likely be offered at the Genetics Clinic.

Who may not be able to join:

  • The patient already has a known or strongly suspected diagnosis of a specific genetic condition that is typically identified through established medical criteria (for example, certain hereditary conditions — confirm with trial site for a full list).
  • The referral has been marked as "Urgent" based on the clinic's standard guidelines.
  • The patient has already had a broad genetic test (such as exome sequencing or genome sequencing) or a thorough gene panel covering all relevant genes, either through a clinic or a research study.
  • The patient or a family member has already been seen by a genetics doctor in the last 2 years for the same health concerns.
  • The patient does not have Ontario Health Insurance Plan (OHIP) or a similar type of health coverage.
  • The referral's only purpose is to test for a gene variant already found in the family, or to receive genetic counselling only.
  • A family member is already taking part in this study for the same reason.
  • The patient or their family does not give consent to participate within 2 weeks of being asked.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
By Invitation
Phase
Not Applicable
Sponsor
The Hospital for Sick Children
Registry
ClinicalTrials.gov
Start date
14 May 2025
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Determine the time-to-event (diagnosis or no active follow-up) of a GS-first (pre-geneticist evaluation) outpatient care model for rare disease compared to standard of care.; Compare clinical utility of GS-first to standard of care from the perspectives of care teams.; Compare personal utility of GS-first to standard-of-care from the perspectives of patients, families, and care teams.; Assess cost-effectiveness as the incremental cost per additional case detected for GS-first compared to standard-of-care from a healthcare system payer perspective.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov