Use of the DBS for the Follow-up of Blood Clinical Parameters of Old People (DBSage)
Primary Purpose
Metabolic Diseases
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of blood
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolic Diseases
Eligibility Criteria
inclusion criteria:
- 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
- Patient affiliated to a national health insurance exclusion criteria:
- Absence of signed informed consent
- Patients with cutaneous disorders which increase the risks caused by the blood test (cutaneous infection)
Sites / Locations
- CHRU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
collection of blood
Arm Description
160 old people for the collection of blood
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02440945
First Posted
April 16, 2015
Last Updated
December 8, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02440945
Brief Title
Use of the DBS for the Follow-up of Blood Clinical Parameters of Old People
Acronym
DBSage
Official Title
Use of the DBS for the Follow-up of Blood Clinical Parameters of Old People
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Inclusion of the last patient
Study Start Date
October 16, 2013 (Actual)
Primary Completion Date
October 16, 2015 (Actual)
Study Completion Date
October 16, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Main objective: Define the analytical concordance between dosages realized on blotting paper (DBS) and classic dosages after blood test for the five markers.
Secondary objectives: Study the influence of the hématocrite, the hemoglobin, the total proteins on the dosages on DBS, and realize a biological collection of blood sample on DBS.
Methods and Feasibility:
The recruitment of the patients will be made with the Service of Geriatrics of the CHRU of Montpellier (Pr C. Jeandel, Dr G. Baptista), which have an important number of compatible patients with the number of planned patients for the study. In the standard blood results will be added a capillary taken which will be deposited on 3 DBS. The study of concordance of biological methods will include on one hand an analytical evaluation of the new methods in terms of reproducibility, repeatability, limit of detection and quantification. On the other hand, a comparison of the values of the dosages on venous taking (blood test) for normal and pathological values will be realized by the method of Bland and Altman associated with a regression of balanced Deming.
Calendar of the study:
M0-M6: optimization of the analytical method / M0-M3: Statutory for the clinical part (CPP..) M4-M16: inclusion of the patients / M6-M20: validation of the dosages on DBS M12-M24: valuation of the results (scientific articles, presentations, exploit the know-how)
Perspectives :
To be able to realize thanks to the DBS the follow-up of these biological parameters at the old people is a major step forward for the patients by avoiding classic blood test and by facilitating the preanalytical phase, making it more easily compatible with the telemedicine in particular, with the dosages practicable at home, in retirement home, at the doctor's office, with simple postal sending to analysis laboratories.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
collection of blood
Arm Type
Experimental
Arm Description
160 old people for the collection of blood
Intervention Type
Device
Intervention Name(s)
Collection of blood
Intervention Description
Blood test on blotting paper DBS (for the patients recruting)
Primary Outcome Measure Information:
Title
Use of the DBS for the follow-up of blood clinical parameters of the old people
Description
The moderate results are vitamin D, albumin, Prealbumin, CRP, Prealbumin, orosomucoide CRP, Orosomucoide
Time Frame
36 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria:
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
Patient affiliated to a national health insurance exclusion criteria:
Absence of signed informed consent
Patients with cutaneous disorders which increase the risks caused by the blood test (cutaneous infection)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvain lehmann, PU-PH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25577016
Citation
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.
Results Reference
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Use of the DBS for the Follow-up of Blood Clinical Parameters of Old People
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