Use of Discarded Surgery Human Tissue Specimens for Basic Science Research

NCT04753593 | Recruiting

• 1 other identifier: PI2021_843_0002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoblast; Vascular Calcification

Keywords

osteoblast; Vascular Calcification; vascular smooth muscle cell; Cardiac valve calcification; Valvular interstitial cell; bone tissue

Outcome Measures

Primary Outcomes (1)

• Success in establishment of Cell Culture Systems from discarded surgery specimens

  Success in establishment of Cell Culture Systems from discarded surgery specimens

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• HIV and hepatitis positive patients

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

discarded human tissue fragments : vessel and bone tissue that are been harvested during surgery and which are not intended to be used for clinical-biological management of patients.

MeSH Terms

Conditions

Vascular Calcification

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Romuald Mentaverri, Pr

CONTACT

03 22 887104; romuald.mentaverri@u-picardie.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 15, 2021
• Study Start: March 16, 2021
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

FR (1)