Metabolic DiseasesDBSageNCT02440945
Use of the DBS for the Follow-up of Blood Clinical Parameters of Old People
A study testing Collection of blood in people with Metabolic Diseases, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metabolic Diseases
- What is being tested?
- Collection of blood
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2013to 16 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Metabolic Diseases
- Being tested
- Collection of blood
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of bloodDevice
Blood test on blotting paper DBS (for the patients recruting)
| Study group | Role | What they receive |
|---|---|---|
| collection of blood | Experimental | 160 old people for the collection of blood Receives: Device: Collection of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study start16 Oct 2013
- Primary completion16 Oct 2015
- Study completion16 Oct 2015
Why it stopped: Inclusion of the last patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain lehmann, PU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440945
- Sponsor's protocol ID
- 9114
- Acronym
- DBSage
- Status last verified
- Dec 2021
- First submitted
- 16 Apr 2015
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25577016
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the DBS for the Follow-up of Blood Clinical Parameters of Old People
- ClinicalTrials.gov ID
- NCT02440945
- Acronym / sponsor ID
- DBSage / 9114
- Conditions
- Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion of the last patient
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Oct 2013 (actual)
- Primary completion
- 16 Oct 2015 (actual)
- Study completion
- 16 Oct 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| collection of blood | Experimental | Device: Collection of blood160 old people for the collection of blood |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of bloodBlood test on blotting paper DBS (for the patients recruting) | Device | collection of blood |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Inclusion of the last patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Background: PubMed 25577016Tall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain lehmann, PU-PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of blood in people with Metabolic Diseases, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusion of the last patient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of the DBS for the follow-up of blood clinical parameters of the old people (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.