NCT03011736

Brief Summary

This clinical trial studies the omission of intact parathyroid hormone testing during surgery in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone testing during parathyroid gland removal may help patients with primary hyperparathyroidism to decrease their time under anesthesia, and decrease the overall time and cost of surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 12, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2018

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

2.2 years

First QC Date

January 4, 2017

Last Update Submit

August 9, 2021

Conditions

Parathyroid Gland AdenomaPrimary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Cure of primary hyperparathyroidism following surgery with intraoperative PTH omission

    Will be evaluated using a binomial exact test. If all N=60 patients achieve cure then the proposed surgery with intraoperative PTH testing committed will be considered non inferior. A 95% confidence interval about pi will be obtained.

    At 2 weeks

Secondary Outcomes (1)

  • Post-operative cost analysis

    At 2 weeks

Study Arms (1)

Supportive Care (parathyroidectomy)

EXPERIMENTAL

Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.

Other: Laboratory Biomarker AnalysisProcedure: Parathyroidectomy

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Supportive Care (parathyroidectomy)
ParathyroidectomyPROCEDURE

Undergo parathyroidectomy

Supportive Care (parathyroidectomy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive 4 dimensional computed tomography (4D CT) for single gland (adenoma) primary hyperparathyroidism
  • Preoperative serum calcium levels \>= 10.9 mg/dL
  • Preoperative parathyroid hormone (PTH) elevated beyond normal range or inappropriately high for associated calcium level
  • Patient has no history of prior neck surgery or external radiation to neck for malignant conditions
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
  • Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

You may not qualify if:

  • Patient has recurrent hyperparathyroidism
  • D CT positive for multiple gland disease
  • Patient has inability to tolerate 4D CT scan (for example; contrast intravenous (IV) allergy, claustrophobia, renal disease)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or nursing female subjects; may be determined in the preoperative evaluation
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography \[EKG\], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Parathyroid NeoplasmsHyperparathyroidism, Primary

Interventions

Parathyroidectomy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesParathyroid DiseasesHyperparathyroidism

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Moshim Kukar

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 5, 2017

Study Start

May 12, 2016

Primary Completion

July 12, 2018

Study Completion

December 24, 2018

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations

US(1)