CClinicalTrials.gg
Not yet recruitingNCT07497477ImprintiNGUpdated Mar 27, 2026

A Study of Multilocus Methylation Abnormalities in Subjects With Imprinting Disorders

An interventional study of Methylation study in Imprinting Disorder, MLID and Multi-locus Imprinting Disturbance, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 6 Months to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Non-randomized
Ages
6 Months to 70 Years
Sex
All
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Study summary

Imprinting disorders may be caused by epimutations. Some subjects exhibit methylation abnormalities in several regions subject to imprinting, a condition known as multilocus imprinting disorder (MLID). The prevalence of MLID is unknown, due to variations in the methodologies used (including technique employed and number of regions studied). The phenotypic consequences of MLID are also poorly understood. Studying the methylation of all the imprinted regions would make it possible to determine the prevalence of MLID as well as its clinical consequences.

Read the detailed description

Imprinting disorders may be secondary to various molecular mechanisms, including "epimutations", i.e. aberrant methylation levels (gain or loss of methylation) at the level of the ICRs. The 11p15 region in humans contains two genes essential for controlling foetal growth: IGF2, expressed from the paternal allele, and whose expression is controlled by an imprinting centre called H19/IGF2: IG-DMR (or ICR1), methylated on the paternal allele; and CDKN1C, expressed from the maternal allele, and whose expression is controlled by a second imprinting centre called KCNQ1OT1:TSS-DMR (or ICR2), methylated on the maternal allele. (Eggermann et al, 2023) Among the diseases linked to parental imprinting, Beckwith Wiedemann syndrome (BWS, prevalence 1/13,500) is an overgrowth syndrome that, in particular, predisposes to the appearance of embryonic tumours during the first years of life. 80% of subjects with BWS have an alteration in the 11p15 region, which may be a loss of ICR2 methylation (around 50%) or a gain of ICR1 methylation (5 to 10%). (Brioude et al, 2018) Silver Russell syndrome (SRS, prevalence 1/50,000) is a syndrome of fetal and postnatal growth restriction, with preservation of head circumference, severe feeding difficulties and early metabolic complications. Approximately 50% of subjects with SRS have a loss of ICR1 methylation in the 11p15 region. (Wakeling et al, 2017). Temple syndrome (TS14) is a fetal and postnatal growth restriction syndrome similar to SRS with neonatal hypotonia, and associated with a risk of early puberty and obesity. This syndrome is usually caused by abnormalities of the 14q32 region at the MEG3/DLK1 locus which is also imprinted (maternal uniparental disomy, paternal deletion or loss of methylation of the MEG3/DLK1:IG-DMR). (Geoffron et al, 2017) For several years now, it has been shown that some subjects with a methylation anomaly at one locus may have methylation anomalies at other regions subject to parental imprinting. This condition is known as multilocus imprinting disorder (MLID). The prevalence of this multilocus disorder is not precisely known, because the methodologies used vary in terms of the technique used and the number of DMRs studied. In some subjects, symptoms of different diseases linked to these different regions may be present. However, little is currently known about the phenotypic consequences of these multilocus disorders. Finally, although most methylation anomalies occur sporadically, a few familial forms of methylation anomalies have been reported, with the common feature of recurrent miscarriages and the presence of multilocus disease in affected subjects. These familial forms have been associated with the presence in the mother of pathogenic variations in the genes encoding factors in the SCMC (subcortical maternal complex). Among other things, these factors are involved in oocyte maturation and the regulation of epigenetic marks after fertilisation and during the first cell divisions. (MacKay et al, 2024)

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Conditions studied

  • Imprinting Disorder
  • MLID
  • Multi-locus Imprinting Disturbance
  • Differentially Methylated Regions
  • Molecular Diagnosis

Keywords

  • Imprinting disorder
  • MLID
  • Multi-locus imprinting disturbance
  • DMR
  • Differentially methylated regions
  • Molecular diagnosis
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In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

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

04

Who can participate

Ages eligible
6 Months to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. "Negative control" population: subjects who have undergone genetic exploration and:

    • Having had a study of normal methylation of the 11p15 region (H19/IGF2: IG-DMR and KCNQ1OT1:TSS-DMR) by the reference technique.
    • And having had a sequencing study of one or more genes involved in a growth pathology (Sanger sequencing and/or NGS analysis) and having concluded in the presence of a pathogenic variant responsible for the pathology.

    OR

    Study population:

    - subjects who had undergone a reference genetic investigation (ASMM-RTqPCR) and for whom the final diagnosis was: gain or loss of methylation at the H19/IGF2:IG-DMR locus (BWS,SRS), at the KCNQ1OT1:TSS-DMR locus (BWS) or at the DLK1/MEG3:IG-DMR locus (TS14).

  2. Affiliation with a social security scheme or beneficiary (excluding AME).
  3. Signature of the consent form by the subject's parents or guardians, or the subject if of age at the time of the study.

Exclusion criteria

Exclusion Criteria:

  • Inability of either the subject (if over 18) or the parents or holder of parental authority to receive informed information about the protocol.
  • Subject (if over 18) or parent or holder of parental authority deprived of their liberty by judicial or administrative decision
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Study design

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

Study arms

  • No intervention
    Negative control group

    Control subjects from the DNA bank, subjects with normal methylation analysis using the reference technique, for whom the final diagnosis is a genetic rather than an epigenetic cause. This population will allow the establishment of normal reference values for the methylation index for each DMR studied using the newly developed technique.

  • Experimental
    Study population

    Subjects with a methylation anomaly in a previously identified imprinted region using the reference technique

    Other: Methylation study

Interventions

  • OtherMethylation study

    Methylation study by high-throughput sequencing technique after enzymatic DNA treatment and DMR capture

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What researchers measure

Primary outcomes

  1. To validate the ability of a new technique (ImprintCap) to detect abnormal methylation levels from a population for which a methylation anomaly has been detected at a region by the reference technique.

    Methylation index reference values for each DMR will be established from the 24 negative control subjects.

    Time frame: 30 month (end of the study)

Secondary outcomes

  1. To determine the proportion (%) of subjects with multilocus disease in the study population.

    In the study population, the methylation indices of each DMR determined by the MethylCap technique will be compared with reference values: multilocus disease will be defined by the presence of a methylation index greater than +3 SDS (methylation gain) or less than -3 SDS (methylation loss) at least one other DMR compared with the established reference values.

    Time frame: 30 month (end of the study)

  2. To compare the phenotypic data (clinical and/or biological) collected during the usual follow-up consultations in the population of subjects with or without multilocus disease.

    Association between the clinical and biological data of the study population according to the presence or absence of multilocus disease.

    Time frame: 30 month (end of the study)

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Study locations

1 site
  • Molecular Endocrinology and Imprinting disorder department - Trousseau Hospital
    Paris, 75012, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 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
NCT07497477
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Mar 27, 2026
Start date
Apr 2026 (estimated)
Primary completion
Oct 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Mar 27, 2026

Study contacts

Frédéric BRIOUDE, MD, PhD
Contact
frederic.brioude@aphp.fr
00 33 1 44 73 66 31
Marie-Pierre LUTON, PhD
Contact
mariepierre.luton@aphp.fr
+33(0) 1 87 89 26 00
Frédéric Brioude, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

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

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