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Balanced Chromosomal TranslocationEarly Phase 1NCT01826708

Breakpoint Analysis of de Novo Apparently Balanced Chromosomal Translocations

A Early Phase 1 study testing Identification of breakpoints in people with Balanced Chromosomal Translocation, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

For every child with developmental delay, the investigators do a constitutional karyotype. This karyotype can reveal an apparently balanced chromosomal rearrangement (no visible loss or gain of genetic material), such as a translocation between two or more chromosomes of accidental occurrence (not transmitted by… Read more about this study

Who is it for?
Any age
Conditions the study is for
Balanced Chromosomal Translocation
What is being tested?
Identification of breakpoints
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteFrance
Study dates
Oct 2011to 8 Jan 2015
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • patient with syndromic psychomotor delay
  • patient with a apparently balanced de novo chromosomal translocation
  • patient with health insurance
  • informed consent signed by patient or by parents or by the legal representative for children

Who cannot join

  • patient with an inherited translocation

Trial locations and contacts

1 site in 1 country.

France1 site
  • Laboratory of Chromosomal Genetics - Universitary Hospital

    Montpellier, 34295

Other trials in France

About this study

Official title: Development of a Technique to Identify New Genes by Studying and Cloning the Breakpoints of de Novo Apparently Balanced Chromosomal Translocations in Patients Presenting With Syndromic Psychomotor Retardation

For every child with developmental delay, the investigators do a constitutional karyotype. This karyotype can reveal an apparently balanced chromosomal rearrangement (no visible loss or gain of genetic material), such as a translocation between two or more chromosomes of accidental occurrence (not transmitted by parents). However, an apparently balanced translocation does not explain the phenotype of the child. Among the hypotheses that could explain the child's symptoms, there is the possibility of another chromosomal abnormality at the translocation breakpoints, another defect elsewhere on the chromosomes or gene disruption at or near the breakpoints. Because the resolution of a constitutional karyotype is limited, these microanomalies can go undiagnosed. The goal of this study is to look for a microanomaly on a chromosome using a technology of higher resolution than that of the conventional karyotype. The proposed study uses DNA microarray technology on DNA extracted from blood lymphocytes to perform high-resolution analysis of all chromosomes to search for an unbalanced microrearrangement (such as loss or gain of chromosomal material). If no microrearrangement is found, the investigators will pursue by looking for a gene disruption defect at or near the breakpoints involved in the translocation. This will be done by first isolating the chromosomes involved in the translocation by flow cytometry and then hybridizing each of the isolated chromosomes on a new microarray. The purpose of this study is to find a possible cause to explain the phenotype (microrearrangement or gene disruption).

Read the detailed description

Psychomotor delay is observed in approximately 3% of the general population and has various causes: environmental, genetic (gene or chromosome) or unknown. Chromosomal abnormalities have been identified in 15% of syndromic psychomotor delay (ie. associated with another symptom). Balanced chromosomal translocations are observed in one out of every 1000 individuals and only 6% of patients with de novo apparently balanced translocations have an abnormal phenotype (Warburton, 1991). Review of the literature, concerning the microarray analysis of de novo apparently balanced translocations in patients with psychomotor delay, reveals:* in 40% of cases: an abnormality not identified on the karyotype, either at the translocation breakpoints or at a different location on the genome,* in 60% of cases: no abnormalities are found with a resolution of up to 25kb (Schluth-Bolard et al., 2009). The technique generally used to clone a breakpoint and identify a disrupted gene is a "walk" on the chromosome. This technique uses fluorescent probes, such as BACs or PACs, located on the derivative chromosomes on both sides of the breakpoints. This technique is labor-intensive, time-consuming and expensive because one must probe along the derivative chromosomes, closer and closer to the breakpoint, in order to find the probe overlapping the breakpoint. The investigators propose an original, innovative and quick technique to map chromosome translocation breakpoints in patients with psychomotor delay and no abnormalities on microarray analysis. The main aim is to develop a technique to identify new genes by cloning and mapping chromosome translocation breakpoints. These genes would then be candidate to explain the phenotype of the patient.The study covers a 24 month period and includes 10 patients. The feasibility of the technique, as well as its application to routine laboratory diagnosis, will be evaluated. The study was approved by our local Bioethics Committee and respects french law of bioethics.Methodology:Patients well be selected during staff meetings including clinicians and biologists. An initial microarray analysis well be performed to identify a gain or loss of genetic material. Samples for which no gain or loss is identified well then undergo flow cytometry to isolate the derivative chromosomes. Each derivative chromosome well then be hybridised to a new microarray, thus revealing the breakpoint. The breakpoints will be confirmed by FISH technique and molecular biology techniques well be applied to clone and sequence the breakpoints. Databases well be used to check for genes located in or around the breakpoints. Required information: Administrative data (3 first letters of the last name and 2 first letters of the first name, date of birth, identification of parents, informed consent). Clinical and biological data (phenotype, karyotype, other genetic studies). Expected results: Development of rapid and less expensive technique to clone translocation breakpoints, Identification of genes potentially involved in mental delay and anomalies of embryo development, Evaluation of the distribution of various causes of syndromic mental delay (unbalanced translocation on microarray, additional rearrangement on microarray, gene disruption, or unidentified cause).

Being tested
Identification of breakpoints
Keywords
Chromosomal translocations, psychomotor delay
Medical subject headings
Translocation, Genetic, Learning Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Identification of breakpointsBiological

    Identification of breakpoints in Molecular Biology : demonstration of a chimeric sequence corresponding to a junction region between the two chromosomes

Study groups in NCT01826708
Study groupRoleWhat they receive
Psychomotor retardation syndromicNo interventionPsychomotor retardation syndromic by Identification of breakpoints
Receives: Biological: Identification of breakpoints

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the proportion of cases for which a cause explaining the phenotype is found for patients with a apparently balance de novo translocation

    Evaluation of the proportion of cases for which a cause explaining the phenotype is found for patients with a apparently balance de novo translocation

    Measured: 6 months and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2013 (estimated)
  2. Study startOct 2011
  3. Primary completion8 Jan 2015
  4. Study completion8 Jan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01826708
Sponsor's protocol ID
8688
Status last verified
Jun 2026
First submitted
29 Mar 2012
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Gribble SM, Prigmore E, Burford DC, Porter KM, Ng BL, Douglas EJ, Fiegler H, Carr P, Kalaitzopoulos D, Clegg S, Sandstrom R, Temple IK, Youings SA, Thomas NS, Dennis NR, Jacobs PA, Crolla JA, Carter NP. The complex nature of constitutional de novo apparently balanced translocations in patients presenting with abnormal phenotypes. J Med Genet. 2005 Jan;42(1):8-16. doi: 10.1136/jmg.2004.024141.

    PubMed 15635069
  • Yauy K, Schneider A, Ng BL, Gaillard JB, Sati S, Coubes C, Wells C, Tournaire M, Guignard T, Bouret P, Genevieve D, Puechberty J, Pellestor F, Gatinois V. Disruption of chromatin organisation causes MEF2C gene overexpression in intellectual disability: a case report. BMC Med Genomics. 2019 Aug 2;12(1):116. doi: 10.1186/s12920-019-0558-8.

    PubMed 31375103

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Identification of breakpoints in people with Balanced Chromosomal Translocation, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the proportion of cases for which a cause explaining the phenotype is found for patients with a apparently balance de novo translocation (time frame: 6 months and 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01826708, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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