Registry of Endocrine Tumors (Thyroid, Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube) (eurocrine)

Registre Tumeurs Endocrine - Eurocrine

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.

Study Overview

• Status: Recruiting
• Conditions: Endocrine Tumor

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: laurent Brunaud, MD, PhD; Email: l.brunaud@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54511
    • Recruiting
    • CHU Nancy
    • Contact: laurent brunaud; Email: l.brunaud@chu-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who undergo surgical procedures for endocrine tumors at CHU Nancy Brabois (University hospital)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

registry of endocrine tumors; Patients who undergo thyroid surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-22.; Patients who undergo parathyroid surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-23; Patients who undergo adrenal surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-24; Patients who undergo pancreatic and digestive surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-26

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications (endocrine surgical procedure)	morbidity rate in percentage (%)	12 months after surgical procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: laurent Brunaud, University of Lorraine

Publications and helpful links

General Publications

• Greilsamer T, Nomine-Criqui C, Thy M, Ullmann T, Zarnegar R, Bresler L, Brunaud L. Robotic-assisted unilateral adrenalectomy: risk factors for perioperative complications in 303 consecutive patients. Surg Endosc. 2019 Mar;33(3):802-810. doi: 10.1007/s00464-018-6346-2. Epub 2018 Jul 11.

Helpful Links

• EUROCRINE WEB SITE

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: thyroid; parathyroid; adrenal; endocrine pancreas; endocrine digestive tube
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms
• Other Study ID Numbers: N° CCTIRS :15.291 Version N°3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No