Parathyroid Gland AdenomaNCT03011736
Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism
A study testing Laboratory Biomarker Analysis and Parathyroidectomy in people with Parathyroid Gland Adenoma and Primary Hyperparathyroidism, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parathyroid Gland Adenoma, Primary Hyperparathyroidism
- What is being tested?
- Laboratory Biomarker Analysis and Parathyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2016to 24 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient has recurrent hyperparathyroidism
- 4D 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Single-Arm, Non-inferiority Study of Omission of Intraoperative Intact Parathyroid Hormone (PTH) During Minimally Invasive Parathyroidectomy for Primary Hyperparathyroidism
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the non-inferiority of omission of parathyroid hormone (PTH) in patients who meet the biochemical and radiological criteria compared to current standard of care (i.e. use of intraoperative parathyroid hormone testing).
SECONDARY OBJECTIVES:
- Cost-analysis to determine savings of omission of intraoperative PTH testing.
OUTLINE:
Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.
After completion of study, patients are followed up at 2 weeks.
- Being tested
- Laboratory Biomarker Analysis, Parathyroidectomy
- Medical subject headings
- Parathyroid Neoplasms, Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
ParathyroidectomyProcedure or surgery
Undergo parathyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (parathyroidectomy) | Experimental | Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery. Receives: Other: Laboratory Biomarker Analysis; Procedure: Parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 2 weeks
Secondary outcomes (1)
Post-operative cost analysis
cost analysis will be based on operative time and omission of intraoperative PTH levels.
Measured: At 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start12 May 2016
- Primary completion12 Jul 2018
- Study completion24 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parathyroid Gland AdenomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshim Kukar, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011736
- Sponsor's protocol ID
- I 274915
- Other IDs
- NCI-2016-01974, I 274915
- Status last verified
- Aug 2021
- First submitted
- 4 Jan 2017
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm, Non-inferiority Study of Omission of Intraoperative Intact Parathyroid Hormone (PTH) During Minimally Invasive Parathyroidectomy for Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03011736
- Acronym / sponsor ID
- I 274915
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 12 May 2016 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 24 Dec 2018 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Determine the non-inferiority of omission of parathyroid hormone (PTH) in patients who meet the biochemical and radiological criteria compared to current standard of care (i.e. use of intraoperative parathyroid hormone testing).
SECONDARY OBJECTIVES:
- Cost-analysis to determine savings of omission of intraoperative PTH testing.
OUTLINE:
Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.
After completion of study, patients are followed up at 2 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (parathyroidectomy) | Experimental | Other: Laboratory Biomarker Analysis, Procedure: ParathyroidectomyPatients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Patient has recurrent hyperparathyroidism
- 4D 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Supportive Care (parathyroidectomy) |
| ParathyroidectomyUndergo parathyroidectomy | Procedure or surgery | Supportive Care (parathyroidectomy) |
Primary outcome
Cure of primary hyperparathyroidism following surgery with intraoperative PTH omission
Time frame: At 2 weeks
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.
1 secondary outcome
Post-operative cost analysis
Time frame: At 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshim Kukar principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Biomarker Analysis and Parathyroidectomy in people with Parathyroid Gland Adenoma and Primary Hyperparathyroidism, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure of primary hyperparathyroidism following surgery with intraoperative PTH omission (time frame: At 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.