Use of Discarded Surgery Human Tissue Specimens for Basic Science Research (HumTisRes)

February 9, 2023 updated by: Centre Hospitalier Universitaire, Amiens
Although it is now established that calcification process result from the joint and coordinated action of different cell types, many areas of shadow remain regarding the spatio-temporal implementation of these events. Highlighting these processes requires additional research to consider new approaches to clinical management of patients with such conditions. It is in this context that the investigators need to use residual human tissue fragments resulting from surgery which are not intended to be used for clinical-biological management of patients. The use of these pseudonymised human tissues will allow the investigators to conduct in vitro cell culture experiences.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80480
        • Recruiting
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The aortic wall and aortic valve discarded specimens will come from the Cardiac Surgery department of Amiens Picardie CHU. The bone and peri-bone discarded specimens will come from the orthopedic surgery services of the CHU Amiens-Picardie.

The collection of samples and their use is part of various projects carried out by research project leaders supported by the laboratory MP3CV (CURS, site CHU sud, Amiens). No genomic analysis is planned for these samples. None clinical data is associated with the interpretation of data collected through the work that will be carried out from these human tissue samples. There are no collections per se, the samples collected are pseudonymized.

Description

Inclusion Criteria:

  • Patients undergoing surgery in the Cardiac Surgery and Orthopedic Surgery departments of the CHU Amiens-Picardie
  • patients who will be beforehand informed
  • patients who will not be opposed to this study.

Exclusion Criteria:

  • HIV and hepatitis positive patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success in establishment of Cell Culture Systems from discarded surgery specimens
Time Frame: 5 years
Success in establishment of Cell Culture Systems from discarded surgery specimens
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2021

Primary Completion (ANTICIPATED)

February 1, 2026

Study Completion (ANTICIPATED)

February 1, 2026

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (ACTUAL)

February 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2021_843_0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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