ClinicalTrials.gg
CompletedNCT04709965Updated Jan 14, 2021

Evaluating Face-Recognition Technology in Syndrome Diagnosis

An interventional study of Face2Gene in Multiple Anomalies, Dysmorphic Features and Inborn Errors of Metabolism, sponsored by Manchester University NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 8 Months and older. Per ClinicalTrials.gov, last updated 2021-01-14.

Sponsored by Manchester University NHS Foundation Trust · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Jan 2018, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
111
Allocation
Non-randomized
Ages
8 Months and older
Sex
All
01

Study summary

Birth defects are relatively common, occurring in 1 in 40 live born babies. They can be single, or multiple. They may occur as part of multiple malformation syndromes, often in association with growth disturbance or intellectual disability. Over 7000 rare syndromes have been identified. Thus, though they are rare they are collectively important. Understanding how a multiple malformation syndrome came about, defining what investigations and health surveillance is needed for affected children and identifying whether there is a treatment is very important for parents and professionals caring for affected children and also for genetic counselling of their extended families, since the majority will have a genetic basis. Diagnosis of these rare disorders is therefore important,but as many syndromes are rare this can be extremely difficult and requires specialist knowledge, many investigations and many hospital appointments. This study aims to determine whether using face-recognition software can improve diagnosis of rare syndromes when used in addition to current routine practice.

Read the detailed description

Clinicians see over 2000 patients per year who have rare syndromes in Manchester NHS clinics. In the majority of these individuals the cause is unknown. Many will have a genetic cause, but knowing which genes to test and being able to access these tests is difficult. When a patient comes to the clinic, details of their medical and developmental history are collected , and they are examined in detail to look at their investigation results. New tests may also be ordered for patients. In many cases, subtle differences in physical features, especially facial features may provide an important clue to the underlying diagnosis. However, because many of the conditions seen are so rare and doctors may not have seen that particular condition before, the diagnosis may not be made immediately at the appointment. In those cases, permission will be sought to take photographs so that further opinions can be sought within the department or by sharing with national and sometimes international colleagues. This is routine practice. Where consent has been obtained for photos, these are then first reviewed in a departmental case-review meeting. They may then also be presented at regional, national or even international meetings aimed at syndrome diagnosis with patient consent.

The study aims to recruit patients who are attending clinics for syndrome diagnosis, and who have differences in their facial features. Such patients will undergo a full routine diagnostic work-up as outlined above. Following that, if patients have consented to having photographs taken as part of standard care, they will be asked if they would consent to upload of the facial photographs to a digital face recognition system, along with upload of a list of key clinical features, to see which diagnoses are suggested by this software.

A group of Inherited Metabolic Disease patients with known diagnoses will be included under the Faces sub-study to establish whether the technology may help to define their phenotype. This group of patients would be asked to send photos to the research team either by email via a secure email address or by post. The study would request one facial photo of each of the biological parents (where applicable and available).

There will first of all be routine discussion of patients and photographs in a case review meeting as per standard practice. Differential diagnoses will be formulated and recorded based on this. Following this, the facial photo will be uploaded to a face recognition system and suggested diagnoses from this recorded. Any diagnostic suggestions considered worthy of investigation will be followed up in line with standard practice.

The investigators will then determine whether this was made a) in the standard way b) only suggested by the face recognition software or c) utilising the two methods together.

Patients will be followed up to see if a final diagnosis is confirmed. The patient/parents will also be sent a questionnaire by email or post 6 months after recruitment. The questionnaire will ask if they had any concerns about using FDNA, if they found it helpful and if so in what way. Another questionnaire to professionals will collect information on how easy they found it to use, how helpful they found it ranging 1-5, did it alter patient management, if so how, and other comments

. The investigators will document whether utilising the software helped to arrive at an earlier diagnosis, whether it impeded the diagnosis by providing misleading or incorrect guidance, whether parents and professionals found its use acceptable and whether it impacted on the patient's management.

02

Conditions studied

  • Multiple Anomalies
  • Dysmorphic Features
  • Inborn Errors of Metabolism
03

In context

Abnormalities, Multiple

17 studies on the registry are indexed under Abnormalities, Multiple; 5 are open to participants now.

Browse Abnormalities, Multiple studies →

Lead sponsor

Manchester University NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 27 are open to participants now.

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

04

Who can participate

Ages eligible
8 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients attending routine genetic clinic/paediatric clinic appointments for diagnosis of a multiple anomaly syndrome where distinctive facial features form part of their presenting pattern.

OR:

  • Biochemically or genetically confirmed diagnosis of inborn disorder of metabolism where no well described dysmorphic facial features are known to be associated with disorder

Exclusion criteria

Exclusion Criteria:

  • Patients under 8 months of age where face-recognition technology has not been shown to be effective.
  • Patients who decline clinical photography as part of standard care.
  • Patients who do not wish to consent to participation in the study even though they consent to photos being taken for standard care.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
111 participants (actual)

Study arms

  • Other
    Main Study

    Patients attending routine genetic clinic/paediatric clinic appointments for diagnosis of a multiple anomaly syndrome where distinctive facial features form part of their presenting pattern.

    Diagnostic Test: Face2Gene

  • Other
    Faces Sub Study

    Patients eligible to be recruited to the Faces Sub Study will have biochemically or genetically confirmed diagnosis of inborn disorder of metabolism where no well described dysmorphic facial features are known to be associated with disorder.

    Diagnostic Test: Face2Gene

Interventions

  • Diagnostic testFace2Gene

    This study investigates whether a new diagnostic intervention (Face2Gene facial recognition software) is better than using standard approach to diagnosis.

06

What researchers measure

Primary outcomes

  1. Number of diagnoses

    The number of diagnoses of rare syndrome disorders made, measured after standard practice

    Time frame: through study completion, an average of 2 years

  2. Number of diagnoses

    The number of diagnoses of rare syndrome disorders made, Measured after use of the Face2Gene app

    Time frame: through study completion, an average of 2 years

Secondary outcomes

  1. Patient satisfaction

    Level of satisfaction of parents with use of a face recognition system and with e-health approaches to genetic counselling and diagnosis in general. Measured via a patient experiences questionnaire that requires both quantitative and qualitative responses. The proportion of patients who found use of the software acceptable will be measured. There results will not be reported on a fixed scale.

    Time frame: 6 months after recruitment.

  2. Professional satisfaction

    Level of satisfaction of professionals with use of a face recognition system. Measured via a colleagues experiences questionnaire that requires both quantitative and qualitative responses. The proportion of professionals who found using the software acceptable/helpful and would continue using the software in practice will be measured. There results will not be reported on a fixed scale.

    Time frame: 24 months

  3. Number of syndromes

    Number of syndromes identified where face recognition software has facilitated genetic investigation.

    Time frame: 24 months

07

Study locations

1 site
  • Manchester University NHS Foundation Trust
    Manchester, Greater Manchester M13 9WL, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Nov 2020, 33 months.

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

Registered
Dec 3, 2020
First posted
Jan 14, 2021
StartActual
Jan 30, 2018
Primary completionActual
Nov 25, 2020
CompletionActual
Nov 25, 2020
Last update
Jan 14, 2021
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 Jan 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04709965
Collaborators
FDNA Inc.
Responsible party
Sponsor
First posted
Jan 14, 2021
Start date
Jan 30, 2018
Primary completion
Nov 25, 2020
Completion
Nov 25, 2020
Last update
Jan 14, 2021

Study contacts

Sofia Douzgou, MD PhD FRCP
principal investigator · Manchester University NHS Foundation Trust

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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