NCT02924532

Brief Summary

The main objective of this study is to establish an optimal threshold Early parathormon (PTH) assay in order to exclude hypoparathyroidism , that is to say to obtain a negative predictive value of hypoparathyroidism highest possible.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 21, 2025

Status Verified

September 1, 2016

Enrollment Period

6.9 years

First QC Date

September 13, 2016

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • the presence/absence of hypoparathyroidism

    hypoparathyroidism is defined as: corrected serum calcium Day 1 \<1.90 and / or symptoms of hypocalcemia (cramps, tingling of the extremities and peri-oral) to Day 1 authenticated by a VAS score\> 3.

    day 1

Study Arms (1)

Patients with total thiroidectomy

Biological: immediate post operative bioassay of Parathyroid Hormone

Interventions

Patients with total thiroidectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Included patients underwent total thyroidectomy from 1 February 2012 to 1 December 2013 at the Nîmes University Hospital

You may qualify if:

  • Patients consecutively operated on between February 1, 2012 and December 1, 2013
  • Total thyroidectomy +/- lymphadenectomy
  • Respect of clinicobiological protocol presented above
  • The ( the ) patient ( e) was informed ( e) on the implementation of the study 's objectives, constraints and patient rights
  • The ( the ) patient ( e) is under ( e) at least 18 years

You may not qualify if:

  • The ( the ) patient ( e) is under guardianship, curatorship or under guard saves justice
  • It is not possible to give to ( the ) patient ( e) informed information
  • History of cervical radiotherapy
  • Previous history of dysfunction of the parathyroid glands
  • Previous history of surgery of the parathyroid glands
  • A history of kidney failure or hepatocellular
  • History of osteomalacia or Paget's disease
  • unhealed cancer antecedent
  • History of sarcoidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Galy-Bernadoy C, Lallemant B, Chambon G, Pham HT, Reynaud C, Alovisetti C, Bonduelle Q, Guedj AM, Lumbroso S, De Brauwere DP. Parathyroid Hormone Assays following Total Thyroidectomy: Is There a Predictive Value? Eur Thyroid J. 2018 Jan;7(1):34-38. doi: 10.1159/000484689. Epub 2017 Dec 7.

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

October 5, 2016

Study Start

February 1, 2012

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 21, 2025

Record last verified: 2016-09