NCT05122845

Brief Summary

To be able to evaluate the predictive value of glycosylated ferritin as a predictive marker of hepatic iron stock in dialysis patients, we need to validate these results with a cohort of healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

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

April 12, 2019

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

19 days

First QC Date

October 19, 2021

Last Update Submit

November 16, 2021

Conditions

Serum BankPlasma BankDialysis

Outcome Measures

Primary Outcomes (1)

  • Number of participant with a serum and plasma bank creation

    it is only a serum and plasma bank constitution

    one day

Study Arms (1)

Healthy volunteers comparators to dialysis subjects

EXPERIMENTAL

Creation of a biological collection for biological analysis

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL

Blood test (10 tubes of 5mL) : \- 6 tubes for : complete blood count, platelets, reticulocyte count, TP-INR, AST, ALT, GGT ferritin, serum iron, CRP, transferrin, soluble transferrin receptors, transferrin saturation coefficient enzymatic creatinine, MDRD, ionogram calcemia, phosphoremia, PTH, 25 (OH) D3, 1.25 (OH) 2D3. 2 dry tubes 2 tube EDTA

Healthy volunteers comparators to dialysis subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Age over 18 years old
  • Healthy volunteers
  • Having given their informed consent in writing
  • Absence of current pathology
  • No current treatment (except contraception)

You may not qualify if:

  • Refusal of consent or absence of signature
  • Minor, subject protected by law, (guardianship or curatorship, administrative protection measure)
  • Pregnant woman, parturient
  • Subject suffering from a condition liable to modify his blood parameters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 17, 2021

Study Start

April 12, 2019

Primary Completion

May 1, 2019

Study Completion

May 23, 2019

Last Updated

November 17, 2021

Record last verified: 2021-11

Locations

FR(1)