ThrombocytopeniaUNITNCT01196884
Immune Thrombocytopenia (ITP) Immune-Genetic Assessment
An observational study of Thrombocytopenia, run by Azienda Sanitaria-Universitaria Integrata di Udine at 13 sites in Italy.
Trial summary
Primary ITP has wide heterogenous biology, presentation and response to therapy. The immune-genetic assessment of ITP may help to identify differences among patients with ITP and optimize the therapeutic choice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thrombocytopenia
- How many people
- 190 participants
- Where
- 13 sitesItaly
- Study dates
- Sep 2010to not given
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Adult patients with primary ITP
Who cannot join
- Secondary ITP
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites, 12 recruiting
- Recruiting
Istituto di Ematologia L. & A. Seragnoli
Bologna, 40100
Nicola Vianelli, MD
- Not yet recruiting
Department of Hematology and Bone Marrow Transplantation Unit, Oncology Center Armando Businco
Cagliari, 09100
Emilio Usala, MD
- Not yet recruiting
UF Ematologia, Policlinico di Careggi
Florence
Antonella Gozzini, MD
- Not yet recruiting
U.O. Ematologia 2, IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
Wilma Barcellini, MD
- Recruiting
Department of Oncology/Haematology, Niguarda Ca'Granda Hospital
Milan
Silvia Cantoni, MD
- Recruiting
Clinica Ematologica, Dipartimento di Medicina Clinica e Sperimentale, Università degli Studi del Piemonte Orientale "Amedeo Avogadro
Novara, 28100
Gianluca Gaidano, Prof.
- Active, not recruiting
Istituto di Immunologia, Dipartimento di Scienze Mediche dell'Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
Novara, 28100
- Not yet recruiting
Department of Medical and Surgical Sciences, University of Padova
Padova, 35100
Fabrizio Fabris, Prof.
- Not yet recruiting
Oncology-Hematology Department, "S. Maria delle Croci" Hospital
Ravenna, 48121
Alfonso Zaccaria, MD
- Not yet recruiting
Institute of Hematology, Catholic University,
Roma, 00168
Valerio De Stefano, MD
- Not yet recruiting
Ematologia, Ospedale Ca' Foncello
Treviso, 31100
Filippo Gherlinzoni, MD
- Recruiting
Clinica Ematologica AOUD S. Maria Misericordia
Udine, 33100
Francesco Zaja, MD, +39 0432559604, zaja.francesco@aoud.sanita.fvg.it
Francesco Zaja, MD
- Not yet recruiting
Ematologia, San Bortolo Hospital
Vicenza, 36100
Francesco Rodeghiero, Prof.
About this study
Official title: IMMUNE-GENETIC ASSESSMENT OF PRIMARY ITP IN ADULT
Primary ITP has wide heterogenous biology, presentation and response to therapy.
The immune-genetic assessment of ITP may help to identify differences among patients with ITP and optimize the therapeutic choice.
- Conditions
- Thrombocytopenia
- Keywords
- Patients with primary Immune Thrombocytopenia (ITP)
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic ITP patients | Not described | |
| ITP patients treated with Rituximab | Not described | |
| ITP patients treated with steroids | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196884
- Sponsor's protocol ID
- UNIT
- Acronym
- UNIT
- Status last verified
- Sep 2010
- First submitted
- 7 Sep 2010
- Last updated
- 20 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMUNE-GENETIC ASSESSMENT OF PRIMARY ITP IN ADULT
- ClinicalTrials.gov ID
- NCT01196884
- Acronym / sponsor ID
- UNIT / UNIT
- Conditions
- Thrombocytopenia
- Keywords
- Patients with primary Immune Thrombocytopenia (ITP)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- Sep 2010
- First posted
- 9 Sep 2010 (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.
Primary ITP has wide heterogenous biology, presentation and response to therapy.
The immune-genetic assessment of ITP may help to identify differences among patients with ITP and optimize the therapeutic choice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic ITP patients | – | – |
| ITP patients treated with Rituximab | – | – |
| ITP patients treated with steroids | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- Adult patients with primary ITP
Key exclusion criteria (1 listed)
- Secondary ITP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Azienda Sanitaria-Universitaria Integrata di Udine at 13 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Zaja, MD (+39 0432 559604, zaja.francesco@aoud.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 20 Mar 2018.