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

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03410394
• Collaborator: (none)
• Enrollment: 3,000
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 25

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 3000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Registre Tumeurs Endocrine - Eurocrine
• Actual Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

1. Postoperative complications (endocrine surgical procedure) [12 months after surgical procedure]

   morbidity rate in percentage (%)

Secondary Outcome Measures

1. Postoperative complications severity (endocrine surgical procedure) [12 months after surgical procedure]

   Dindo-Clavien classification in percentage (%)

2. Postoperative mortality (endocrine surgical procedure) [12 months after surgical procedure]

   mortality rate in percentage (%)

3. CT imaging before endocrine surgical procedure (Tumor characteristics) [Baseline]

   Density in Hounsfield unit (HU)

4. CT imaging before endocrine surgical procedure (Coronary artery score) [Baseline]

   CAC score in Agatston score unit (HU)

5. CT imaging before endocrine surgical procedure (Sarcopenia) [preoperative period]

   Evaluation of sarcopenia using L3 skeletal muscle index (in cm²/m²)

6. Bone mineral density [Baseline]

   dual-energy x-ray absorptiometry (DEXA) (in T-score unit)

7. Intraoperative systolic arterial pressure [Intraoperative]

   systolic arterial pressure (in mmHg)

8. Intraoperative diastolic arterial pressure [Intraoperative]

   diastolic arterial pressure (in mmHg)

9. Parathormone plasma levels [Baseline and up to 12 months after surgical procedure]

   Parathormone (in pg/mL)

10. Aldosterone plasma levels [Baseline and up to 12 months after surgical procedure]

    Aldosterone (in pmol/L)

11. Plasma renin activity [Baseline and up to 12 months after surgical procedure]

    Renin (in μIU/mL)

12. Plasma free metanephrines [Baseline and up to 12 months after surgical procedure]

    metanephrines (in nmol/L)

13. PET scanning [Baseline]

    standardized uptake values (SUV tumor / SUV liver ratio)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Nancy	Vandœuvre-lès-Nancy		France	54511

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

• Principal Investigator: laurent Brunaud, University of Lorraine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• EUROCRINE WEB SITE

Publications

None provided.

• Responsible Party: Laurent BRUNAUD, investigator, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT03410394
• Other Study ID Numbers: N° CCTIRS :15.291 Version N°3
• First Posted: Jan 25, 2018
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Laurent BRUNAUD, investigator, Central Hospital, Nancy, France: adrenal; thyroid; parathyroid; endocrine pancreas; endocrine digestive tube
• Additional relevant MeSH terms: Endocrine Gland Neoplasms

Study Results

No Results Posted as of Mar 9, 2022