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RecruitingNCT03919981CYSTEA-BONEUpdated Mar 3, 2025

CYSTEA-BONE Clinical Study

An observational study in Nephropathic Cystinosis, sponsored by Hospices Civils de Lyon. Recruiting at 13 sites in 4 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
2 Years and older
Sex
All
01

Study summary

Nephropathic Cystinosis (NC) is an orphan inherited autosomal recessive disease characterised as a generalized lysosomal storage disease due to a deficiency of the cystine lysosomal transport protein, cystinosin.

Patients with NC usually receive cysteamine. Bone impairment was recently recognized as a late complication of NC, occurring at adolescence or early adulthood. Even though the exact underlying pathophysiology is unclear, at least six hypotheses are discussed, and mainly cysteamine toxicity and/or direct bone effect of the Cystinosin (CTNS) mutation. Because of the potential dramatic impact on quality of life of this novel complication, research should aim to better understand bone disease in NC.

The primary objective of this study is to evaluate the action of cysteamine on osteoclastic differentiation and resorption activity of NC patients, depending on the underlying genotype. The Secondary objective is to describe the clinical bone status of NC patients depending on their underlying genotype.

02

Conditions studied

  • Nephropathic Cystinosis
03

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with nephropathic cystinosis (NC)

Inclusion criteria

  • Male and female subjects with confirmed diagnosis of nephropathic cystinosis (defined by clinical signs, White Blood Cells (WBC) cystine level and/or mutation), currently receiving oral cysteamine.
  • Age > 2 years.
  • Subjects and/or their parents/ legal guardian must provide non opposition prior to participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Subjects who, in the opinion of the Investigator, are not able or willing to comply with the protocol.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • nephropathic cystinosis patients receiving cysteamine

    nephropathic cystinosis patients receiving cysteamine. The blood samples of the group will be used to evaluate the action of cysteamine on osteoclastic differentiation and resorption activity of NC patients, depending on the underlying genotype.

    Other: Blood sampling

Interventions

  • OtherBlood sampling

    25 mL blood sample will be collected on citrate tubes for osteoclastic analysis.

05

What researchers measure

Primary outcomes

  1. Number of positive Tartrate-resistant acid phosphatase (TRAP) cells

    Number of positive TRAP cells will be assessed at the end of osteoclast differentiation from circulating monocytes

    Time frame: 1 day

06

Study locations

7 of 13 sites recruiting
  • CHU de Besançon
    Besançon, 25030, France
    • Francois NOBILI, MD,PhD · Contact · fnobili@chu-besancon.fr · 03 81 21 88 15
    • Francois NOBILI, MD,PhD · Principal investigator
    Not yet recruiting
  • CHU Bordeaux - Hôpital Pellegrin tripode
    Bordeaux, 33000, France
    Recruiting
  • Hôpital Femme Mère Enfant
    Bron, 69677, France
    Recruiting
  • Hôpital Jeanne de Flandre
    Lille, 59037, France
    Recruiting
  • Hopital Edouard Herriot
    Lyon, 69437, France
    Recruiting
  • AP-HM - Timone Enfants
    Marseille, 13385, France
    Not yet recruiting
  • CHU Paris - Hôpital Robert Debré
    Paris, 75019, France
    • Georges DESCHENES, PU PH · Contact · georges.deschenes@aphp.fr · 01 40 03 24 67
    • Georges DESCHENES, PU PH · Principal investigator
    Recruiting
  • CHU Paris - Hôpital Necker-Enfants Malades
    Paris, 75743, France
    • Aude SERVAIS, PU PH · Contact · aude.servais@aphp.fr · 01 44 49 54 16
    • Olivia BOYER, MD PHD · Contact · olivia.boyer@aphp.fr · 01 44 49 54 16
    • Aude SERVAIS, PU PH · Principal investigator
    • Olivia BOYER, MD PHD · Sub investigator
    Recruiting
  • Hôpital des Enfants
    Toulouse, 31059, France
    • Stéphane DECRAMER, PU, PH · Contact · rdecramer.s@chu-toulouse.fr · 05 34 55 84 58
    • Stéphane DECRAMER, PU, PH · Principal investigator
    Not yet recruiting
  • CHRU Nancy - Hôpital Brabois Enfants
    Vandœuvre-lès-Nancy, 54500, France
    • Mario PONGAS, MD PHD · Contact · a.pongas@outlook.com · 03 83 15 47 41
    • Mario PONGAS, MD PHD · Principal investigator
    Recruiting
  • Klinik für Pädiatrische Nieren-, Leber- und Stoffwechselerkrankungen
    Hannover, 30625, Germany
    Not yet recruiting
  • IRCCS Ospedale Pediatrico Bambino Gesù
    Roma, 00146, Italy
    • Marcella GRECO, MD PHD · Contact · marcella.greco@opbg.net · 06 68592393
    • Francesco EMMA, PU PH · Contact · francesco.emma@opbg.net · 06 68592393
    • Marcella GRECO, MD PHD · Principal investigator
    • Francesco EMMA, PU PH · Sub investigator
    Not yet recruiting
  • Hacettepe University Faculty of Medicine
    Ankara, 06100, Turkey
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03919981
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Apr 18, 2019
Start date
Apr 5, 2019
Primary completion
Oct 5, 2026 (estimated)
Completion
Oct 5, 2026 (estimated)
Last update
Mar 3, 2025

Study contacts

Justine BACCHETTA, MD PhD
Contact
justine.bacchetta@chu-lyon.fr
04 27 85 61 30 ext. +33
Segolene GAILLARD
Contact
segolene.gaillard@chu-lyon.fr
04 27 85 77 28 ext. +33

Oversight

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

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