ClinicalTrials.gg
Not yet recruitingNCT07709728BOBCATUpdated Jul 16, 2026

Biomarkers for Babies and Young Children With Ataxia Telangiectasia

An observational study in Ataxia Telangiectasia, sponsored by University of Nottingham. Not yet recruiting. Open to participants aged 0 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by University of Nottingham · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
56
Ages
0 Years to 5 Years
Sex
All
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Study summary

The goal of this observational study is to identify progressive changes of quantitative brain and lung imaging, serum and movement-related biomarkers reflecting disease progression in pre-symptomatic infants and very young children (0-5 yo) with a genetic diagnosis of A-T, that could be used in future early-life intervention trials.

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Conditions studied

  • Ataxia Telangiectasia

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In context

Ataxia Telangiectasia

42 studies on the registry are indexed under Ataxia Telangiectasia; 7 are open to participants now.

This study's planned enrollment of 56 is close to the median of 60 across 12 observational studies indexed under Ataxia Telangiectasia.

Browse Ataxia Telangiectasia studies →

Lead sponsor

University of Nottingham is the lead sponsor of 465 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants with A-T will be recruited principally via the National Paediatric A-T Clinic based at Nottingham University Hospitals NHS Trust. A second route for recruitment is the A-T Society, a UK charity that provides support and advocacy for people with A-T and their families.

Participants without A-T or other conditions described in the exclusion criteria, will be infants and young children undergoing general anaesthesia at Nottingham University Hospitals NHS Trust for minor surgical procedures (e.g. circumcision, orchidopexy) or diagnostic MRI.

Eligibility criteria

  1. Participants with A-T

    • Inclusion criteria

      • Genetic diagnosis of Ataxia Telangiectasia
      • Aged under two years old at the time of first recruitment
      • Parents/ guardians able to give
    • Exclusion criteria

      • to MRI
      • Diagnosis of any other neurogenetic disease
      • On approved treatment targeting neurodegeneration in A-T at the time of first recruitment
      • Participating in the trial of novel therapy targeting neurodegeneration in A-T at the time of first recruitment

    NB - co-recruitment to other observational studies or trials is permitted. If a family chooses to enrol their child in an interventional study targeting neurodegeneration, provided that the intervention trial allows co-recruitment, we would like to retain the participant in the BOBCAT study until its conclusion. In this circumstance, the child's data would not be considered as part of the natural history dataset but would instead be used to demonstrate the feasibility of collecting longitudinal quantitative imaging and other biomarker data in people with A-T during infancy and early childhood.

  2. Participants without A-T

    • Inclusion criteria

      • Child undergoing general anaesthesia at Nottingham University Hospitals NHS Trust for minor surgical procedures or diagnostic MRI.
      • Aged 0-5 years (to match the age range of participants with A-T throughout the longitudinal study).
      • Parents/ guardians able to give informed consent
    • Exclusion criteria

      • Diagnosis of any neurological or neurodevelopmental disease
      • Diagnosis of any other significant chronic childhood illness
      • On any long-term prescribed treatments
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
56 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • A-T participants

    Up to 4 longitudinal visits, depending on enrolment window Brain MRI/Assessment/Movement Quantitative Analysis/Blood Test

  • non A-T participants / Controls

    One single visit Blood test only

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What researchers measure

Primary outcomes

  1. Brain MRI - Volumetric structural T1-weighted (T1)

    Volume (mm³) - Acquisition parameters aligned to HEALthy Brain and Child Development Study (HBCD)

    Time frame: Up to 4 years ( last visit)

  2. Brain MRI - Magnetic Resonance Spectroscopy (MRS): quantification of N-acetyl aspartate in the cerebellum

    Chemical shift (ppm) - Acquisition parameters aligned to HEALthy Brain and Child Development Study (HBCD)

    Time frame: Up to 4 years ( last visit)

  3. Brain MRI - Diffusion Weighted Imaging (DWI)

    Apparent Diffusion Coefficient (mm²/s) - Acquisition parameters aligned to HEALthy Brain and Child Development Study (HBCD)

    Time frame: Up to 4 years ( last visit)

  4. Neurological and developmental assessment

    * A-TNEST test * Denver Developmental Screening Test II (DDST)

    Time frame: Up to 4 years ( last visit)

  5. Quantitative movement analysis

    Quantitative analysis of limb, facial and eye movements will be made using a machine learning approach.

    Time frame: Up to 4 years ( last visit)

  6. Serum markers of neurodegeneration

    * Neurofilament light chain (NFL) * Glial fibrillary acidic protein (GFAP)

    Time frame: Up to 4 years ( last visit)

Secondary outcomes

  1. Lung MRI

    • Lung MRI metrics, feasibility, and the results of the quantitative analyses, where it has been possible to do this. * free-breathing proton-based ventilation * structural images using the proton-based techniques

    Time frame: Up to 4 years ( last visit)

  2. Natural sleep MRI procedure

    Completion rates (%) and image quality (Signal-to-Noise Ratio, SNR, and Contrast-to-Noise Ratio CNR - unitless ) when using the sleep MRI protocol

    Time frame: Up to 4 years ( last visit)

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Study locations

No study locations are listed for this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Aug 2029, 35 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2026
First posted
Jul 16, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Aug 31, 2029
CompletionEst.
Aug 31, 2029
Last update
Jul 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07709728
Responsible party
Sponsor
First posted
Jul 16, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Aug 31, 2029 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Jul 16, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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