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2015-01-01
2030-01-01
2030-01-01
3000
NCT03410394
Central Hospital, Nancy, France
Central Hospital, Nancy, France
OBSERVATIONAL
Registry of Endocrine Tumors (Thyroid, Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube)
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-01-10 | N/A | 2025-02-11 |
2018-01-24 | N/A | 2025-02-12 |
2018-01-25 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/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 c |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Postoperative complications (endocrine surgical procedure) | morbidity rate in percentage (%) | 12 months after surgical procedure |
| Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: laurent Brunaud, MD, PhD Phone Number: Email: l.brunaud@chru-nancy.fr |
Study Contact Backup Name: Brunaud Phone Number: Email: l.brunaud@chru-nancy.fr |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
