Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)

NCT ID: NCT06133244

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-19

Study Completion Date

2028-04-30

Brief Summary

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Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.

Detailed Description

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Conditions

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Systemic Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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VEDOSS

defined as RP, presence of SSc specific autoantibodies (ACA, ATA, ARA), puffy fingers and abnormal nailfold capillaroscopy (giant capillaries or capillary loss with or without haemorrhages), but not fulfilling the EULAR-ACR 2013 classification criteria for SSc

Imaging, blood samples, fuctional tests and physical examination

Intervention Type DIAGNOSTIC_TEST

Imaging, blood samples, fuctional tests and physical examination

SSc with disease duration of < 4 years without hand contractures

Imaging, blood samples, fuctional tests and physical examination

Intervention Type DIAGNOSTIC_TEST

Imaging, blood samples, fuctional tests and physical examination

SSc with hand contractures

Imaging, blood samples, fuctional tests and physical examination

Intervention Type DIAGNOSTIC_TEST

Imaging, blood samples, fuctional tests and physical examination

Interventions

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Imaging, blood samples, fuctional tests and physical examination

Imaging, blood samples, fuctional tests and physical examination

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years

Exclusion Criteria

* Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Julia Spierings, MD PhD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UMC Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Facility Contacts

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Julia Spierings, MD

Role: primary

088 755 5555

References

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Greveling M, Ong VH, Denton C, Foppen W, Herman A, Jeffries-Owen N, Kortekaas M, Masselink I, Mulder DJ, Schriemer R, Vonk MC, de Vries-Bouwstra JK, Welsing P, Mastbergen S, Spierings J. Hand function impairment in Systemic sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) - a longitudinal observational multicentre study protocol. BMJ Open. 2025 Mar 13;15(3):e095283. doi: 10.1136/bmjopen-2024-095283.

Reference Type DERIVED
PMID: 40082008 (View on PubMed)

Other Identifiers

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NL85445.041.23

Identifier Type: -

Identifier Source: org_study_id

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