Non-invasive Test for Acute Rejection Identification in Heart Transplanted Patients

NCT04274712 | Unknown DMC

• 1 other identifier: INNOGRAFTRS001
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to test INNOGRAFT Heart Suite in a clinical setting, using a previously collected set of plasma samples from patients who underwent heart transplant and routinely or symptoms-based surveillance during the period 2016- 2019.

Conditions

Acute Rejection of Cardiac Transplant

Keywords

liquid biopsy; cfDNA

Outcome Measures

Primary Outcomes (1)

• Comparison with gold standard: endomyocardial biopsy

  To evaluate specificity and sensitivity of INNOGRAFT Heart Suite in identifying transplant rejection, using blood samples collected from heart transplanted patients during the same day of endomyocardial biopsy (EMB) using the histological study of EMB specimen as reference technique.

  6 months

Secondary Outcomes (2)

• Comparison with ISHLT classification

  6 months

• cfDNA modifiers

  6 months

Interventions

INNOGRAFT Heart Suite DIAGNOSTIC_TEST

Liquid biopsy to identify acute rejection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart transplanted consecutive adult patients , who underwent their regular surveillance protocol during the first 3 years post intervention.

You may qualify if:

• Age≥18 years;
• Heart transplanted during 2016-2019 and under surveillance for preventing acute rejection;
• Heart transplanted before 2016 but undergoing routinely or symptom-based surveillance for preventing acute rejection;
• Signed written informed consent for reuse of biosamples for research purposes; OR Signed written informed consent for study partecipation;
• Underwent at least 1 blood sampling at the same time of the EMB;
• Clinical data collected during at least 1 surveillance visit (same time of blood sampling and EMB) available;
• Availability of EMB readings for EMB performed at the same time of blood sampling.

You may not qualify if:

• They were subjected to re-transplantation
• They were subjected to multi-organ transplantation

Sponsors & Collaborators

• Myway Gentics Srl: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator

Study Sites (1)

IRCCS Fondazione Policlinico San Matteo

Pavia, 27100, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma from transplanted patient

Study Officials

• Valentina Favalli, PhD

  Myway Gentics Srl

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2020
• First Posted: February 18, 2020
• Study Start: February 3, 2020
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IT (1)