NCT03108547

Brief Summary

The investigators studied whether scalp hair cortisol and testosterone levels differed between sarcoidosis patients both with and without fatigue and healthy controls.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

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

June 13, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

March 31, 2017

Last Update Submit

April 5, 2017

Conditions

Sarcoidosis

Keywords

SarcoidosisScalp hair cortisol and testosteroneFatigueBiomarkerPsychological distress

Outcome Measures

Primary Outcomes (1)

  • Scalp hair cortisol differences between sarcoidosis patients with and without fatigue and healthy controls

    Differences between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue, and healthy controls

    1 month

Secondary Outcomes (13)

  • Scalp hair testosterone differences between sarcoidosis patients with and without fatigue and healthy controls

    1 month

  • Scalp hair cortisone differences between sarcoidosis patients with and without fatigue and healthy controls

    1 month

  • Fatigue Assessment Scale (FAS)

    1 day

  • King's Sarcoidosis Questionnaire (KSQ)

    1 day

  • EuroQol-5D-5L (EQ-5D-5L)

    1 day

  • +8 more secondary outcomes

Study Arms (3)

Sarcoidosis - fatigued

Men and women with sarcoidosis and a score of ≥ 22 on the Fatigue Assessment Scale. A small hair sample will be cut and the participants will be asked to complete questionnaires on fatigue, anxiety, depression, stress and quality of life.

Other: Determination of scalp hair steroids

Sarcoidosis - non-fatigued

Men and women with sarcoidosis and a score of \< 22 on the Fatigue Assessment Scale. A small hair sample will be cut and the participants will be asked to complete questionnaires on fatigue, anxiety, depression, stress and quality of life.

Other: Determination of scalp hair steroids

Healthy controls

Hair steroid values of a previously collected normal values study in adults will be used as healthy controls

Other: Determination of scalp hair steroids

Interventions

Determination of scalp hair steroidsOTHER
Healthy controlsSarcoidosis - fatiguedSarcoidosis - non-fatigued

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diagnosis of sarcoidosis based on consistent clinical features/BAL fluid analysis/ PA according to the latest ATS/ERS/WASOG statement on sarcoidosis

You may qualify if:

  • Age of at least 18 years
  • Diagnosis of sarcoidosis based on consistent clinical features/BAL fluid analysis/ PA according to the latest ATS/ERS/WASOG statement on sarcoidosis
  • Able to speak, read and write in Dutch
  • Presence of sarcoidosis related fatigue, defined as a ≥ 22 score on the Fatigue Assessment Scale
  • Other causes of fatigue are excluded or contributing comorbidities are optimally treated (e.g. OSAS, hypothyroidism or anemia)

You may not qualify if:

  • Unable to understand questionnaires (intellectual impaired or language barrier)
  • Hair length \< 1 cm
  • Use of systemic and/ or inhalation steroids in the last year
  • Use of methylphenidate (Ritalin) \< 1 month before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • van Manen MJG, Wester VL, van Rossum EFC, van den Toorn LM, Dorst KY, de Rijke YB, Wijsenbeek MS. Scalp hair cortisol and testosterone levels in patients with sarcoidosis. PLoS One. 2019 Jun 14;14(6):e0215763. doi: 10.1371/journal.pone.0215763. eCollection 2019.

    PMID: 31199799DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Scalp hair string

MeSH Terms

Conditions

SarcoidosisFatigue

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • M. S. Wijsenbeek, MD, PhD

    Erasmus University Medical Center, Rotterdam, the Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 11, 2017

Study Start

June 13, 2014

Primary Completion

January 5, 2015

Study Completion

January 5, 2015

Last Updated

April 11, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share