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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03410394
Other study ID # N° CCTIRS :15.291 Version N°3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date January 1, 2025

Study information

Verified date March 2022
Source Central Hospital, Nancy, France
Contact laurent Brunaud, MD, PhD
Email l.brunaud@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This registry aims to collect informations about patients with endocrine tumors (Thyroid, Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube) who undergo endocrine surgical procedures. This registry is part of the Eurocrine Project.


Description:

The EUROCRINE project aims to decrease morbidity and mortality of rare endocrine tumours, by means of a pan-European database. Recording and accessing data at the European level, makes it possible to identify these tumours, which cannot be distinguished at local or national level, because of their extreme rarity. Dissemination of results aims to raise clinical standards and reduce differences in practise between clinics and member states, and thereby diminish morbidity and mortality. Comparison of practice and outcomes will be especially interesting for centres wanting to improve their standards to what is currently considered best practice. EUROCRINE will be a key means by which the medical profession, researchers, health policy makers, and not least patients, can benefit from an increase in knowledge related to diagnosis, treatment, and future clinical research in the field of rare endocrine tumours.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients who undergo surgical procedures for endocrine tumors at the University Nancy Brabois Hospital Exclusion Criteria: - unable to receive clear information - refusal to sign the consent form

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Nancy Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complications (endocrine surgical procedure) morbidity rate in percentage (%) 12 months after surgical procedure
Secondary Postoperative complications severity (endocrine surgical procedure) Dindo-Clavien classification in percentage (%) 12 months after surgical procedure
Secondary Postoperative mortality (endocrine surgical procedure) mortality rate in percentage (%) 12 months after surgical procedure
Secondary CT imaging before endocrine surgical procedure (Tumor characteristics) Density in Hounsfield unit (HU) Baseline
Secondary CT imaging before endocrine surgical procedure (Coronary artery score) CAC score in Agatston score unit (HU) Baseline
Secondary CT imaging before endocrine surgical procedure (Sarcopenia) Evaluation of sarcopenia using L3 skeletal muscle index (in cm²/m²) preoperative period
Secondary Bone mineral density dual-energy x-ray absorptiometry (DEXA) (in T-score unit) Baseline
Secondary Intraoperative systolic arterial pressure systolic arterial pressure (in mmHg) Intraoperative
Secondary Intraoperative diastolic arterial pressure diastolic arterial pressure (in mmHg) Intraoperative
Secondary Parathormone plasma levels Parathormone (in pg/mL) Baseline and up to 12 months after surgical procedure
Secondary Aldosterone plasma levels Aldosterone (in pmol/L) Baseline and up to 12 months after surgical procedure
Secondary Plasma renin activity Renin (in µIU/mL) Baseline and up to 12 months after surgical procedure
Secondary Plasma free metanephrines metanephrines (in nmol/L) Baseline and up to 12 months after surgical procedure
Secondary PET scanning standardized uptake values (SUV tumor / SUV liver ratio) Baseline
See also
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