Stem Cell Transplant ComplicationsNCT05523336
Pro-ADM vs PCT in Patients With Complications Post Hematopoietic Stem Cell Transplantation
An observational study of Stem Cell Transplant Complications, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 1 site in Italy.
Trial summary
Prospective, multicenter, spontaneous, non-interventional, non pharmacological. Study aimed at evaluate kinetics, diagnostic and prognostic value of pro-ADM (proadrenomedullin) as compared to PCT (procalcitonin) in patients presenting with infections or other complications post hematopoietic stem cell transplantation… Read more about this study
- Who is it for?
- Ages 28 days to 39 years
- Conditions the study is for
- Stem Cell Transplant Complications
- What is being tested?
- observation
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 20 Oct 2022to Mar 2025
- 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 28 days to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric and young adult patients affected by malignant or non-malignant disorders referred for HCST
Who may be able to join
- Written informed consent of the parents/legal guardians and patient's assent/consent according to national regulations. For subjects who turn 18 years of age during participation in this study, participation in the future use portion of the study after their 18th birthday requires that they sign the informed consent statement following turning 18 years of age.
- Age at time of registration from 28 days to less than 39 years of age.
- Malignant disease (i.e. Acute lymphocytic leukemia (ALL), Acute myeloid leukemia (AML), Myelodysplastic syndromes (MDS)) or nonmalignant disease (e.g. immunodeficiency or inherited disorders of metabolism or hemoglobinopathies etc.) indicated for allogeneic HSCT.
Who cannot join
- Age less than 28 days
- Obese patients with body mass index: > 30 kg/m^2.
- Impaired cardiac function: severe cardiac insufficiency indicated by left ventricle ejection fraction (LVEF) ≤ 35%.
- Impaired liver function indicated by Bilirubin >3 times the upper limit of normal (ULN), or aspartate aminotransferase/alanine aminotransferase (AST/ALT) >10 times ULN
- Impaired renal function indicated by estimated glomerular filtration rate (GFR), according to the Schwartz formula for ages 1-17 and according to CDKEPI creatinine equation for ages above 17 years old) < 60 mL/min/1,73m^2.
- Concurrent severe active infection at the start of conditioning regimen
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
Turin, 10126
Franca Fagioli, MD, 0039011313 ext. 5997, franca.fagioli@unito.it
About this study
Official title: Prospective Non-Interventional Trial to Evaluate Kinetics, Diagnostic and Prognostic Value of Pro-ADM as Compared to PCT in Patients Presenting With Infections or Other Complications Post Hematopoietic Stem Cell Transplantation (HSCT)
Prospective, multicenter, spontaneous, non-interventional, non pharmacological. Study aimed at evaluate kinetics, diagnostic and prognostic value of pro-ADM (proadrenomedullin) as compared to PCT (procalcitonin) in patients presenting with infections or other complications post hematopoietic stem cell transplantation (HSCT)
Read the detailed description
Evaluation of diagnostic performance of pro-ADM as compared to palliative care therapy (PCT) in paediatric and young adult patients with any type of complications after hematopoietic stem cell transplantation or with transplant related complications.
- Conditions
- Stem Cell Transplant Complications
- Being tested
- observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation and prospective data collection
| Study group | Role | What they receive |
|---|---|---|
| Paediatric patients receiving HCTS with infectious complications post HCTS | Paediatric patients receiving allogeneic hematopoietic stem cell transplantation (HCTS) and who present with infectious complications post HSCT or with transplant related complications (acute graft-versus-host disease- GvHD-, sinusoidal obstruction syndrome -SOS-, engraftment-ES- and pre-engraftment syndrome- pre-ES-, graft failure, thrombotic microangiopathy associated with HSCT- TA-TMA or those without complications post HSCT). Receives: Other: observation | |
| Paediatric patients receiving HCTS without infectious complications post HCTS | Paediatric patients receiving HCTS without infectious complications post HCTS Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of diagnostic performance of pro-ADM as compared to PCT in patients receiving HSCT
In order to achieve the objective, it will be considered paediatric and young adults patients affected by malignant/non-malignant disorders who have been subjected to HSCT and present with infectious complications post HSCT or with transplant related complications (acute graft-versus-host disease (GvHD), sinusoidal obstruction syndrome (SOS), engraftment (ES) and pre-engraftment syndrome (pre-E), graft failure, thrombotic microangiopathy associated with HSCT (TA-TMA) or those without complications post HSCT).
Measured: 180 days after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start20 Oct 2022
- Primary completionSep 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Franca Fagioli, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Investigators
- Franca Fagioli, MD, Principal investigator, AOU Città della Salute e della Scienza di Torino - OIRMManuela Spadea, MD, Study chair, AOU Città della Salute e della Scienza di Torino - OIRM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523336
- Sponsor's protocol ID
- Trap-ADM
- Status last verified
- May 2023
- First submitted
- 29 Aug 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-Interventional Trial to Evaluate Kinetics, Diagnostic and Prognostic Value of Pro-ADM as Compared to PCT in Patients Presenting With Infections or Other Complications Post Hematopoietic Stem Cell Transplantation (HSCT)
- ClinicalTrials.gov ID
- NCT05523336
- Acronym / sponsor ID
- Trap-ADM
- Conditions
- Stem Cell Transplant Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 31 Aug 2022 (actual)
- 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.
Prospective, multicenter, spontaneous, non-interventional, non pharmacological. Study aimed at evaluate kinetics, diagnostic and prognostic value of pro-ADM (proadrenomedullin) as compared to PCT (procalcitonin) in patients presenting with infections or other complications post hematopoietic stem cell transplantation (HSCT)
Detailed description
Evaluation of diagnostic performance of pro-ADM as compared to palliative care therapy (PCT) in paediatric and young adult patients with any type of complications after hematopoietic stem cell transplantation or with transplant related complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paediatric patients receiving HCTS with infectious complications post HCTS | – | Other: observationPaediatric patients receiving allogeneic hematopoietic stem cell transplantation (HCTS) and who present with infectious complications post HSCT or with transplant related complications (acute graft-versus-host disease- GvHD-, sinusoidal obstruction syndrome -SOS-, engraftment-ES- and pre-engraftment syndrome- pre-ES-, graft failure, thrombotic microangiopathy associated with HSCT- TA-TMA or those without complications post HSCT). |
| Paediatric patients receiving HCTS without infectious complications post HCTS | – | Other: observationPaediatric patients receiving HCTS without infectious complications post HCTS |
Who may qualify
- Ages
- 28 days to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric and young adult patients affected by malignant or non-malignant disorders referred for HCST
Key inclusion criteria (3 listed)
- Written informed consent of the parents/legal guardians and patient's assent/consent according to national regulations. For subjects who turn 18 years of age during participation in this study, participation in the future use portion of the study after their 18th birthday requires that they sign the informed consent statement following turning 18 years of age.
- Age at time of registration from 28 days to less than 39 years of age.
- Malignant disease (i.e. Acute lymphocytic leukemia (ALL), Acute myeloid leukemia (AML), Myelodysplastic syndromes (MDS)) or nonmalignant disease (e.g. immunodeficiency or inherited disorders of metabolism or hemoglobinopathies etc.) indicated for allogeneic HSCT.
Key exclusion criteria (6 listed)
- Age less than 28 days
- Obese patients with body mass index: > 30 kg/m^2.
- Impaired cardiac function: severe cardiac insufficiency indicated by left ventricle ejection fraction (LVEF) ≤ 35%.
- Impaired liver function indicated by Bilirubin >3 times the upper limit of normal (ULN), or aspartate aminotransferase/alanine aminotransferase (AST/ALT) >10 times ULN
- Impaired renal function indicated by estimated glomerular filtration rate (GFR), according to the Schwartz formula for ages 1-17 and according to CDKEPI creatinine equation for ages above 17 years old) < 60 mL/min/1,73m^2.
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 |
|---|---|---|
| observationobservation and prospective data collection | Other | Paediatric patients receiving HCTS with infectious complications post HCTS, Paediatric patients receiving HCTS without infectious complications post HCTS |
Primary outcome
Evaluation of diagnostic performance of pro-ADM as compared to PCT in patients receiving HSCT
Time frame: 180 days after HSCT
In order to achieve the objective, it will be considered paediatric and young adults patients affected by malignant/non-malignant disorders who have been subjected to HSCT and present with infectious complications post HSCT or with transplant related complications (acute graft-versus-host disease (GvHD), sinusoidal obstruction syndrome (SOS), engraftment (ES) and pre-engraftment syndrome (pre-E), graft failure, thrombotic microangiopathy associated with HSCT (TA-TMA) or those without complications post HSCT).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
Related trials for Stem Cell Transplant Complications
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Active, not recruitingObservational study
Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease
Bone Marrow Transplant Complications
Not yet recruitingPhase 1
Expanded Donor Stem Cells for Poor Graft Function After Stem Cell Transplantation in Children
Poor Graft Function, Hematopoietic Stem Cell Transplantation Complications
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
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.
Franca Fagioli, MD principal investigator
AOU Città della Salute e della Scienza di Torino - OIRM
Manuela Spadea, MD study chair
AOU Città della Salute e della Scienza di Torino - OIRM
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 Stem Cell Transplant Complications, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna 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 3 inclusion and 6 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 25 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celeste Cagnazzo, PhD (00390113135171, celeste.cagnazzo@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of diagnostic performance of pro-ADM as compared to PCT in patients receiving HSCT (time frame: 180 days after HSCT). It is what the study was designed to measure, not a finding.
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 25 May 2023.