NCT07356804

Brief Summary

A prospective study is proposed to serially determine new biomarkers: Calprotectin and Serum Amyloid Protein, alongside 'conventional' biomarkers: CRP and ESR, to help evaluate their utility in routine clinical practice

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
5.6 years until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
Last Updated

January 21, 2026

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

November 13, 2018

Last Update Submit

January 12, 2026

Conditions

Juvenile Idiopathic ArthritisFlare Up, Symptom

Keywords

CalprotectinBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Serum Calprotectin in pediatric population with rheumatological inflammatory diseases

    To assess the clinical usefulness ofserum Calprotectin in pediatric population with rheumatological inflammatory diseases

    Months 3, 6, 9 and 12

Secondary Outcomes (2)

  • Serum Amyloid Protein in pediatric population with rheumatological inflammatory diseases

    Months 3, 6, 9 and 12

  • Correlation biomarkers

    1 year

Interventions

CalprotectineDIAGNOSTIC_TEST

Determination of calprotectin and amyloid protein in the serum of patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in follow-up in our Pediatric Rheumatology Unit, with the diagnoses of: Juvenile Idiopathic Arthritis, Connective Diseases or Autoinflammatory Diseases

You may qualify if:

  • Patients in follow-up in our Pediatric Rheumatology Unit, with the diagnoses of: Juvenile Idiopathic Arthritis, Connective Diseases or Autoinflammatory Diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Creu i Sant Pau Hospital

Barcelona, Catalonia, 08025, Spain

Location

MeSH Terms

Conditions

Arthritis, JuvenileSymptom Flare Up

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesRecurrenceDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Berta Magallares

    Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2018

First Posted

January 21, 2026

Study Start

September 5, 2018

Primary Completion

December 30, 2019

Study Completion

June 30, 2020

Last Updated

January 21, 2026

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)