NCT03434067

Brief Summary

The half-life of the parathyroid hormone is about 4min, blood pth test is use in operation to confirm that parathyroid tumor is removed. but the blood pth test is time consuming and unpractical in most of hospital. this study will compare the application of rapid PTH test paper in operation of hyperparathyroidism.PTH test were measured in operation in different way. it will test at the time of preoperation, 15 minutes after surgery, 1 hour after surgery and 24 hours after surgery. thus evaluate the reliability and accuracy of PTH test paper in evaluating the Miami principles with the linear relation of blood PTH and the PTH test paper method.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

January 27, 2018

Last Update Submit

September 17, 2018

Conditions

HyperthyroidismThyroidectomyPTHImmunochromatographic

Keywords

hyperthyroidismthyroidectomyPTHimmunochromatographic assay

Outcome Measures

Primary Outcomes (3)

  • Serum PTH

    Routine serum PTH test, using immunoluminescence.

    0 minutes, 15 minutes, 1 hour and 24 hours post operation

  • Serum calcium

    Routine serum electrolyte detection.

    0 minutes, 15 minutes, 1 hour and 24 hours post operation

  • PTH test paper

    PTH test paper test for blood

    0 minutes, 15 minutes, 1 hour and 24 hours post operation

Study Arms (4)

Primary hyperthyroidism

Patients diagnosed with primary hyperparathyroidism are prepared for parathyroid surgery. PTH test paper is used addtional at the time point according to Miami principle

Secondary hyperthyroidism

Patients diagnosed with Secondary hyperthyroidism are prepared for parathyroid surgery. PTH test paper is used addtional at the time point according to Miami principle

Unilateral thyroidectomy

Patients diagnosed with unilateral thyroid benign tumor were prepared for unilateral thyroidectomy. PTH test paper is used addtional at postoperation

thyroidectomy and bilateral CCD

Patients diagnosed with bilateral thyroid carcinoma were prepared to undergo total thyroidectomy and bilateral central clearing.PTH test paper is used addtional at postoperation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We use the characteristics of short half-life of the parathyroid hormone and try to evaluate it by PTH strip semi-quantitative method. PTH, blood calcium and PTH test were measured at pre-operation, 15 minutes after surgery, 1 hour after surgery and 24 hours after surgery. To evaluate the reliability and accuracy of PTH strip in evaluating the Miami principles with the linear relation of blood PTH and the test paper method.

You may qualify if:

  • Primary hyperthyroidism.
  • Secondary hyperthyroidism
  • Unilateral thyroidectomy.
  • Total thyroidectomy and bilateral central compartment dissection

You may not qualify if:

  • age Older than 70 or younger than 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wen-xin ZHAO

Fuzhou, Fujian, 350001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

In addition to the normal preoperative preparation of blood Biospecimen before admission, the PTH test paper was used to detection the PTH in remanent blood biospecimen .

MeSH Terms

Conditions

Hyperthyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • wen-xin zhao, md

    Fujian Medical University Union Hospital

    STUDY CHAIR

Central Study Contacts

wenxin zhao, md

CONTACT

13365910359zhaowx@fjmu.edu.cn

bo wang, md

CONTACT

13705947900wangbo@fjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

January 27, 2018

First Posted

February 15, 2018

Study Start

January 1, 2018

Primary Completion

June 30, 2018

Study Completion

December 30, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

CN(1)