Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management

NCT ID: NCT03997253

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-21

Study Completion Date

2025-11-30

Brief Summary

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Increased indications for transplantation continue to worsen the shortage of organs and need the extension of graft sampling criteria and the search for new potential sources of organs. Despite undeniable success in the short term, due to major advances in surgery, medicine and research, transplant recipients continue to face the risk of chronic rejection and long-term complications.

The University Hospital Federation "FHU SUPORT" was created to optimize the chances of success of the organ transplant and improve the quality of life of the transplanted patient. FHU SUPORT 's ambition is based on a translational strategy that presents two priority areas:

Axis 1: Optimization, evaluation, conditioning of the donor, graft, recipient Axis 2: Personalized follow-up of the transplanted patient in the short and long term Identifying factors for long-term graft and patient survival through translational research from a common cohort and biological collection will predict transplant rejection, prolong graft function, or improve the patient's care.

Detailed Description

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Conditions

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Organ Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

various blood and urine samples will be collected from the recipient at D0, D1, D3, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection ancillary studies : stools at D0 D7 M1 and M3 will be collected for liver transplant patient
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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blood, bile and urine samples

blood and urine samples at D0,D1, D3 D7, D14, M1, M3, M6 and M12

Group Type EXPERIMENTAL

blood and urine samples

Intervention Type OTHER

various blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection

Interventions

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blood and urine samples

various blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female over 18 (no age limit)
* affiliated to a social security organization
* Recipient (s) of a kidney, liver or heart transplant
* followed by at least one of the FHU SUPORT centers (Tours, Poitiers, Limoges, Rennes)
* having given informed consent to participate in the cohort.

Exclusion Criteria

* Patient unable to understand the information given by the investigator
* People under the protection of justice
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Federation FHU SUPORT

UNKNOWN

Sponsor Role collaborator

University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Limoges hospital

Limoges, , France

Site Status RECRUITING

Poitiers Hospital

Poitiers, , France

Site Status RECRUITING

Rennes Hospital

Rennes, , France

Site Status NOT_YET_RECRUITING

Tours hospital

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sophie ALAIN, MD

Role: CONTACT

+33 5 55 056 728

Facility Contacts

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Sophie Alain, MD

Role: primary

+33 5 55 056 728

Antoine Thierry, MD

Role: primary

Florian LEMAITRE

Role: primary

Ephrem Salame, MD

Role: primary

Other Identifiers

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87RI18-0027

Identifier Type: -

Identifier Source: org_study_id

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