Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 80 of 365 for:    transthyretin

Use of the DBS for the Follow-up of Blood Clinical Parameters of Old People (DBSage)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02440945
Recruitment Status : Unknown
Verified April 2013 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Metabolic Diseases Device: Collection of blood Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of the DBS for the Follow-up of Blood Clinical Parameters of Old People
Study Start Date : October 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: collection of blood
160 old people for the collection of blood
Device: Collection of blood
Blood test on blotting paper DBS (for the patients recruting)




Primary Outcome Measures :
  1. Use of the DBS for the follow-up of blood clinical parameters of the old people [ Time Frame: 36 months ]
    The moderate results are vitamin D, albumin, Prealbumin, CRP, Prealbumin, orosomucoide CRP, Orosomucoide



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440945


Contacts
Layout table for location contacts
Contact: Sylvain LEHMANN, PU-PH 33(0)467337123 s-lehmann@chu-montpellier.fr
Contact: Christophe HIRTZ, MCU 33(0)467330420 c-hirtz@chu-montpellier.fr

Locations
Layout table for location information
France
CHRU Recruiting
Montpellier, France, 34295
Contact: SYLVAIN LEHMANN, PU-PH    33(0)4 67 33 71 23    s-lehmann@chu-montpellier.fr   
Contact: Christophe HIRTZ, MCU    33(0)437330420    c-hirtz@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Sylvain lehmann, PU-PH University Hospital, Montpellier