Group IdentificationIMAandGENDERNCT02894671
Ischemia Modified Albumin (IMA) Expression in the Male and Female Population
An observational study of Group Identification, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The study has as general objective to analyze in the adult population, (male and female) the presence of a very common protein, in its normal form and modified, isolated from the blood of patients and called albumin. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Group Identification
- What is being tested?
- blood exams
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Feb 2016
- Phase
- Observational
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 males under 45y, 25 males over 45y, 25 fertile females and 25 infertile females
Who may be able to join
- caucasic
- signed informative consensus
Who cannot join
- patients wearing articular devices
- pregnant (for female)
- fractured patients
- patients with oncologic diseases, hemochromatosis, hepatic diseases, thalassaemia, diabetes, anemia (Hb<9)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica
Bologna, Italy, 40136
About this study
The study has as general objective to analyze in the adult population, (male and female) the presence of a very common protein, in its normal form and modified, isolated from the blood of patients and called albumin. The opportunity to observe the distribution of this protein in the population, provides the basis to be able to perform this type of assay also in the population of patients with pathologies, in the near future, with the aim of increasing knowledge on the subjective tolerability to orthopedic implants.
Read the detailed description
100 patients, waiting for elective surgical intervention (such as hip replacement or primary knee ligament reconstruction, arthroscopy), distributed evenly by gender and age (50 men, 50 women including 25 postmenopausal and 25 in bearing age) and afferent to the Department of Surgery Prosthetic hip and knee of our Institute, will be enrolled. At execution time of blood sampling routine, a further specimen of whole blood (7 ml) will be added which will be sent to the Medical technology laboratory for IMA dosage. In addition, total albumin, ferritin, transferrin and serum iron will be analyzed from clinical pathological laboratory. The investigators will be able to analyze the IMA and normalized IMA distributions with respect to gender factor and correlation with the three listed blood tests (ferritin, transferrin and serum iron).
- Conditions
- Group Identification
- Being tested
- blood exams
- Medical subject headings
- Social Identification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood examsOther
in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin
| Study group | Role | What they receive |
|---|---|---|
| male under 45y | blood exams performed on males under 45years (in a range of 20-90 years) not wearing articular devices, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) Receives: Other: blood exams | |
| male over 45y | blood exams performed on males over 45years (in a range of 20-90 years) not wearing articular devices, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) Receives: Other: blood exams | |
| fertile female | blood exams performed on fertile females (in a range of 20-90 years) not wearing articular devices, no pregnant, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) Receives: Other: blood exams | |
| infertile female | blood exams performed on infertile females (in a range of 20-90 years) not wearing articular devices, no pregnant, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) Receives: Other: blood exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMA dosage
Dosage of IMA (mg/ml), with ELISA assay for each patient
Measured: one year
Secondary outcomes (2)
iron, transferrin dosages
Dosage of iron and transferrin (mg/ml) values in patients blood
Measured: one year
Ferritin dosages
Dosage of ferritin (ng/ml) values in patients blood
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Group IdentificationStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Bracci, Istituto Ortopedico Rizzoli
- Investigators
- Giovanni Bracci, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894671
- Sponsor's protocol ID
- 83/14
- Acronym
- IMAandGENDER
- Status last verified
- Sep 2016
- First submitted
- 12 Feb 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Govender R, De Greef J, Delport R, Becker PJ, Vermaak WJ. Biological variation of ischaemia-modified albumin in healthy subjects. Cardiovasc J Afr. 2008 May-Jun;19(3):141-4.
PubMed 18568173Catalani S, Leone R, Rizzetti MC, Padovani A, Apostoli P. The role of albumin in human toxicology of cobalt: contribution from a clinical case. ISRN Hematol. 2011;2011:690620. doi: 10.5402/2011/690620. Epub 2010 Oct 31.
PubMed 22084701Bar-Or D, Rael LT, Lau EP, Rao NK, Thomas GW, Winkler JV, Yukl RL, Kingston RG, Curtis CG. An analog of the human albumin N-terminus (Asp-Ala-His-Lys) prevents formation of copper-induced reactive oxygen species. Biochem Biophys Res Commun. 2001 Jun 15;284(3):856-62. doi: 10.1006/bbrc.2001.5042.
PubMed 11396981
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemia Modified Albumin (IMA) Expression in the Male and Female Population
- ClinicalTrials.gov ID
- NCT02894671
- Acronym / sponsor ID
- IMAandGENDER / 83/14
- Conditions
- Group Identification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Sep 2016 (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.
The study has as general objective to analyze in the adult population, (male and female) the presence of a very common protein, in its normal form and modified, isolated from the blood of patients and called albumin. The opportunity to observe the distribution of this protein in the population, provides the basis to be able to perform this type of assay also in the population of patients with pathologies, in the near future, with the aim of increasing knowledge on the subjective tolerability to orthopedic implants.
Detailed description
100 patients, waiting for elective surgical intervention (such as hip replacement or primary knee ligament reconstruction, arthroscopy), distributed evenly by gender and age (50 men, 50 women including 25 postmenopausal and 25 in bearing age) and afferent to the Department of Surgery Prosthetic hip and knee of our Institute, will be enrolled. At execution time of blood sampling routine, a further specimen of whole blood (7 ml) will be added which will be sent to the Medical technology laboratory for IMA dosage. In addition, total albumin, ferritin, transferrin and serum iron will be analyzed from clinical pathological laboratory. The investigators will be able to analyze the IMA and normalized IMA distributions with respect to gender factor and correlation with the three listed blood tests (ferritin, transferrin and serum iron).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| male under 45y | – | Other: blood examsblood exams performed on males under 45years (in a range of 20-90 years) not wearing articular devices, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) |
| male over 45y | – | Other: blood examsblood exams performed on males over 45years (in a range of 20-90 years) not wearing articular devices, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) |
| fertile female | – | Other: blood examsblood exams performed on fertile females (in a range of 20-90 years) not wearing articular devices, no pregnant, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) |
| infertile female | – | Other: blood examsblood exams performed on infertile females (in a range of 20-90 years) not wearing articular devices, no pregnant, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 males under 45y, 25 males over 45y, 25 fertile females and 25 infertile females
Key inclusion criteria (2 listed)
- caucasic
- signed informative consensus
Key exclusion criteria (4 listed)
- patients wearing articular devices
- pregnant (for female)
- fractured patients
- patients with oncologic diseases, hemochromatosis, hepatic diseases, thalassaemia, diabetes, anemia (Hb<9)
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 |
|---|---|---|
| blood examsin serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin | Other | fertile female, infertile female, male over 45y, male under 45y |
Primary outcome
IMA dosage
Time frame: one year
Dosage of IMA (mg/ml), with ELISA assay for each patient
2 secondary outcomes
iron, transferrin dosages
Time frame: one year
Ferritin dosages
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Background: PubMed 18568173Govender R, De Greef J, Delport R, Becker PJ, Vermaak WJ. Biological variation of ischaemia-modified albumin in healthy subjects. Cardiovasc J Afr. 2008 May-Jun;19(3):141-4.
- Background: PubMed 22084701Catalani S, Leone R, Rizzetti MC, Padovani A, Apostoli P. The role of albumin in human toxicology of cobalt: contribution from a clinical case. ISRN Hematol. 2011;2011:690620. doi: 10.5402/2011/690620. Epub 2010 Oct 31.
- Background: PubMed 11396981Bar-Or D, Rael LT, Lau EP, Rao NK, Thomas GW, Winkler JV, Yukl RL, Kingston RG, Curtis CG. An analog of the human albumin N-terminus (Asp-Ala-His-Lys) prevents formation of copper-induced reactive oxygen species. Biochem Biophys Res Commun. 2001 Jun 15;284(3):856-62. doi: 10.1006/bbrc.2001.5042.
- Individual participant dataSharing planned: No
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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.
Giovanni Bracci, MD principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group Identification, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 9 Sep 2016. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IMA dosage (time frame: one year). 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 NCT02894671, which also lists 3 linked publications.
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 9 Sep 2016.