Rare Disease Trial, Recruiting NCT07102966 Sponsor: Baylor College of Medicine Condition: Rare Disease
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Rare Disease Trial, Recruiting

NCT07102966
Recruiting 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:

  • Your baby is between 0 and 90 days old and has not yet received a diagnosis
  • Your baby shows signs or symptoms that doctors strongly suspect may be caused by a genetic condition
  • Babies with a wide range of different symptoms or physical findings may be considered

Who may not be able to join:

  • Babies whose prenatal blood screening test (NIPT) already showed a possible chromosome problem
  • Babies whose amniocentesis results (fluid testing during pregnancy) came back abnormal
  • Babies whose newborn screening test pointed to a problem with how their body processes nutrients or energy
  • Babies who already had an abnormal FISH test result showing extra or missing chromosomes (such as trisomy 13, trisomy 18, or Turner syndrome)
  • Babies already diagnosed with Down syndrome
  • Babies who only have unusual physical features but no other birth differences or health problems
  • Babies with a single, isolated birth difference (such as a spine opening, cleft lip or palate, heart wall defect, or diaphragm defect) on its own
  • Babies whose birth differences are known to be caused by exposure to harmful substances during pregnancy (such as alcohol or certain medications like Isotretinoin)
  • Babies whose birth differences are linked to the mother having diabetes during pregnancy
  • Babies with a specific combination of birth differences known as VACTERL association (confirm with trial site)
  • Babies who are medically unstable and need to be moved to a higher level of care

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.

Contact this trial

Principal Investigator: Brendan Lee, MD, PhD, Baylor College of Medicine

Phone: 281-224-0600

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
28 October 2025
Est. completion
31 March 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Effectiveness of Consultagene

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