NCT02440945

Brief Summary

It is about an interventional study.The use of the blotting paper called "Dried Blood Spot" or DBS is a method of systematic neonatal screening of the metabolic diseases. Indeed, it has multiple interests: realized thanks to lancets, it is much less invasive than a classic blood collection. Besides, the transport of the blood sampling is facilitated because most of the analysts are stable on DBS at room temperature one week or more. Finally the use of this DM reduces the infectious risks bound to the manipulation of the blood sampling and to the inactivation of microorganisms. The moderate results are vitamin D, albumin, prealbumin, CRP, orosomucoide The DBS presents a major interest for the care of the old and fragile people who have on one hand a low peripheral venous capital and on the other hand for whom the possibility of a dosage on DBS will allow a facilitated biological follow-up. Indeed it is very important to detect as soon as possible the most fragile old people, those who have the biggest risk of seeing their health degrading during a physical, psychic or social stress, to concentrate the efforts of coverage and limit these risks. The advantage of the biological criteria is the speed of the test making (a blood test), in the absence of necessity of active participation by the patient (the clinical criteria require to test the patient in the walking, to test its muscular strength, etc.) and in the saving of time diagnosis for the clinician. The blood biological markers of the fragility are essentially the rate of 25OH vitamin D, the markers of undernutrition (albumin, prealbumin) and of the inflammation (CRP, orosomucoïde). These last four parameters are now measurable from the DBS thanks to the quantitative mass spectrometry.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

October 16, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2015

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

April 16, 2015

Last Update Submit

December 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Use of the DBS for the follow-up of blood clinical parameters of the old people

    The moderate results are vitamin D, albumin, Prealbumin, CRP, Prealbumin, orosomucoide CRP, Orosomucoide

    36 months

Study Arms (1)

collection of blood

EXPERIMENTAL

160 old people for the collection of blood

Device: Collection of blood

Interventions

Blood test on blotting paper DBS (for the patients recruting)

collection of blood

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Man / woman
  • Having a standard blood test planned during their consultation or their hospitalization in the service of Geriatrics of Pr C. Jeandel
  • Signature of the informed consent by the patient

You may not qualify if:

  • Absence of signed informed consent
  • Patients with cutaneous disorders which increase the risks caused by the blood test (cutaneous infection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU

Montpellier, 34295, France

Location

Related Publications (1)

  • Tall ML, Lehmann S, Diouf E, Gerard C, Filali S, Gabelle A, Hirtz C, Gabert L, Sauvinet V, Pirot F, Pivot C. [Injectable preparation of labeled leucine with the carbon 13 for a clinical research program on the Alzheimer disease: pharmaceutical control of raw materials and the finished product and stability study]. Ann Pharm Fr. 2015 Jan;73(1):43-59. doi: 10.1016/j.pharma.2014.06.002. Epub 2014 Jul 11. French.

    PMID: 25577016BACKGROUND

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Sylvain lehmann, PU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 16, 2015

First Posted

May 12, 2015

Study Start

October 16, 2013

Primary Completion

October 16, 2015

Study Completion

October 16, 2015

Last Updated

December 29, 2021

Record last verified: 2021-12

Locations