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Trial record 61 of 6670 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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

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ClinicalTrials.gov Identifier: NCT03410394
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Laurent BRUNAUD, Central Hospital, Nancy, France

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
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Registre Tumeurs Endocrine - Eurocrine
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

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



Primary Outcome Measures :
  1. Postoperative complications (endocrine surgical procedure) [ Time Frame: 12 months after surgical procedure ]
    morbidity rate in percentage (%)


Secondary Outcome Measures :
  1. Postoperative complications severity (endocrine surgical procedure) [ Time Frame: 12 months after surgical procedure ]
    Dindo-Clavien classification in percentage (%)

  2. Postoperative mortality (endocrine surgical procedure) [ Time Frame: 12 months after surgical procedure ]
    mortality rate in percentage (%)

  3. CT imaging before endocrine surgical procedure (Tumor characteristics) [ Time Frame: Baseline ]
    Density in Hounsfield unit (HU)

  4. CT imaging before endocrine surgical procedure (Coronary artery score) [ Time Frame: Baseline ]
    CAC score in Agatston score unit (HU)

  5. CT imaging before endocrine surgical procedure (Sarcopenia) [ Time Frame: preoperative period ]
    Evaluation of sarcopenia using L3 skeletal muscle index (in cm²/m²)

  6. Bone mineral density [ Time Frame: Baseline ]
    dual-energy x-ray absorptiometry (DEXA) (in T-score unit)

  7. Intraoperative systolic arterial pressure [ Time Frame: Intraoperative ]
    systolic arterial pressure (in mmHg)

  8. Intraoperative diastolic arterial pressure [ Time Frame: Intraoperative ]
    diastolic arterial pressure (in mmHg)

  9. Parathormone plasma levels [ Time Frame: Baseline and up to 12 months after surgical procedure ]
    Parathormone (in pg/mL)

  10. Aldosterone plasma levels [ Time Frame: Baseline and up to 12 months after surgical procedure ]
    Aldosterone (in pmol/L)

  11. Plasma renin activity [ Time Frame: Baseline and up to 12 months after surgical procedure ]
    Renin (in μIU/mL)

  12. Plasma free metanephrines [ Time Frame: Baseline and up to 12 months after surgical procedure ]
    metanephrines (in nmol/L)

  13. PET scanning [ Time Frame: Baseline ]
    standardized uptake values (SUV tumor / SUV liver ratio)


Biospecimen Retention:   Samples With DNA
samples from tumor specimen. All patients signed a specific and validated form allowing the collection of samples with DNA (CNIL N° DC2014-2114)


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who undergo surgical procedures for endocrine tumors at CHU Nancy Brabois (University hospital)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410394


Contacts
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Contact: laurent Brunaud, MD, PhD l.brunaud@chru-nancy.fr
Contact: Brunaud l.brunaud@chru-nancy.fr

Locations
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France
CHU Nancy Recruiting
Vandœuvre-lès-Nancy, France, 54511
Contact: laurent Brunaud       l.brunaud@chu-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: laurent Brunaud University of Lorraine

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laurent BRUNAUD, investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03410394     History of Changes
Other Study ID Numbers: N° CCTIRS :15.291 Version N°3
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laurent BRUNAUD, Central Hospital, Nancy, France:
adrenal
thyroid
parathyroid
endocrine pancreas
endocrine digestive tube
Additional relevant MeSH terms:
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Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Parathyroid Hormone
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Calcium-Regulating Hormones and Agents