Pro-ADM vs PCT in Patients With Complications Post Hematopoietic Stem Cell Transplantation

NCT05523336 | Unknown

• 1 other identifier: Trap-ADM
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 (HSCT)

Conditions

Stem Cell Transplant Complications

Outcome Measures

Primary Outcomes (1)

• 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).

  180 days after HSCT

Study Arms (2)

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).

Other: observation

Paediatric patients receiving HCTS without infectious complications post HCTS

Paediatric patients receiving HCTS without infectious complications post HCTS

Other: observation

Interventions

observation OTHER

observation and prospective data collection

Paediatric patients receiving HCTS with infectious complications post HCTS; Paediatric patients receiving HCTS without infectious complications post HCTS

Eligibility Criteria

• Age: 28 Days - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric and young adult patients affected by malignant or non-malignant disorders referred for HCST

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna: lead

Study Sites (1)

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

Turin, 10126, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample collection will be performed on T1 (first day of fever or day in ich a transplant-related complication is diagnosed), T2 (3 days after T1), T3 (10 days after T1). It will be analysed PCT and pro-ADM values

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Franca Fagioli, MD

  AOU Città della Salute e della Scienza di Torino - OIRM

  PRINCIPAL INVESTIGATOR

• Manuela Spadea, MD

  AOU Città della Salute e della Scienza di Torino - OIRM

  STUDY CHAIR

Central Study Contacts

Celeste Cagnazzo, PhD

CONTACT

00390113135171; celeste.cagnazzo@unito.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: October 20, 2022
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)