Parathyroid CarcinomaNCT03046524
Parathyroid Cancer Versus Atypical Parathyroid Neoplasm; Investigating Their Clinical Characteristics and Biological Behavior
An observational study of Parathyroid Carcinoma and Parathyroid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: 1. Identify the clinical characteristics of parathyroid (PTH) cancer and PTH atypical neoplasms 2. Investigate if PTH carcinoma and atypical neoplasm present a biological behaviour and have a different impact on the health of the patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parathyroid Carcinoma, Parathyroid Neoplasm
- What is being tested?
- Chart Review
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2015to 16 Oct 2017
- Phase
- Observational
- 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
Study population: The medical records of all adult patients that had a parathyroidectomy for primary PHPT in MD Anderson Cancer Center between the years of 1/1/2002 and 12/31/2013.
Who may be able to join
- All patients from MDACC diagnosed with PHPT that have a histopathological diagnosis of PTH carcinoma or atypical parathyroid neoplasm between the years 1/1/2002 and 12/31/2013
Who cannot join
- Pediatric patients
- Cases with incomplete records
- Patients where the follow-up will be less than six months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Objectives:
- Identify the clinical characteristics of parathyroid (PTH) cancer and PTH atypical neoplasms
- Investigate if PTH carcinoma and atypical neoplasm present a biological behaviour and have a different impact on the health of the patients
Read the detailed description
Data between the years of 1/1/2002 and 12/31/2013 will be analyzed. The medical records of all adult patients that had a parathyroidectomy for primary PHPT in MD Anderson Cancer Center will be screened in order to identify patients that had a histopathological diagnosis of parathyroid carcinoma or atypical parathyroid neoplasm.
- Conditions
- Parathyroid Carcinoma, Parathyroid Neoplasm
- Being tested
- Chart Review
- Keywords
- Parathyroid Carcinoma, Parathyroid Neoplasm, Chart Review
- Medical subject headings
- Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chart ReviewOther
Data between the years of 1/1/2002 and 12/31/2013 analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Parathyroid Carcinoma | Charts from participants with histopathological diagnosis of parathyroid carcinoma. Receives: Other: Chart Review | |
| Atypical Parathyroid Neoplasm | Charts from participants with parathyroid tumors with some atypical features found in parathyroid carcinoma, but not enough histologic criteria to make the diagnosis of parathyroid carcinoma. Receives: Other: Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information Collected on Clinical Characteristics of Parathyroid (PTH) Cancer and PTH Atypical Neoplasms by Conducting a Retrospective Chart Review
Measured: 5 years
Information Collected on PTH Carcinoma's Biological Behaviour and Impact on the Health of the Patients by Conducting a Retrospective Chart Review
Measured: 5 years
Information Collected on Atypical Neoplasm's Biological Behaviour and Impact on the Health of the Patients \by Conducting a Retrospective Chart Review
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start6 Oct 2015
- Primary completion16 Oct 2017
- Study completion16 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parathyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy D. Perrier, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046524
- Sponsor's protocol ID
- PA15-0808
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parathyroid Cancer Versus Atypical Parathyroid Neoplasm; Investigating Their Clinical Characteristics and Biological Behavior
- ClinicalTrials.gov ID
- NCT03046524
- Acronym / sponsor ID
- PA15-0808
- Conditions
- Parathyroid Carcinoma, Parathyroid Neoplasm
- Keywords
- Parathyroid Carcinoma, Parathyroid Neoplasm, Chart Review
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Oct 2015 (actual)
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 8 Feb 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.
Objectives:
- Identify the clinical characteristics of parathyroid (PTH) cancer and PTH atypical neoplasms
- Investigate if PTH carcinoma and atypical neoplasm present a biological behaviour and have a different impact on the health of the patients
Detailed description
Data between the years of 1/1/2002 and 12/31/2013 will be analyzed. The medical records of all adult patients that had a parathyroidectomy for primary PHPT in MD Anderson Cancer Center will be screened in order to identify patients that had a histopathological diagnosis of parathyroid carcinoma or atypical parathyroid neoplasm.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parathyroid Carcinoma | – | Other: Chart ReviewCharts from participants with histopathological diagnosis of parathyroid carcinoma. |
| Atypical Parathyroid Neoplasm | – | Other: Chart ReviewCharts from participants with parathyroid tumors with some atypical features found in parathyroid carcinoma, but not enough histologic criteria to make the diagnosis of parathyroid carcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The medical records of all adult patients that had a parathyroidectomy for primary PHPT in MD Anderson Cancer Center between the years of 1/1/2002 and 12/31/2013.
Key inclusion criteria (1 listed)
- All patients from MDACC diagnosed with PHPT that have a histopathological diagnosis of PTH carcinoma or atypical parathyroid neoplasm between the years 1/1/2002 and 12/31/2013
Key exclusion criteria (3 listed)
- Pediatric patients
- Cases with incomplete records
- Patients where the follow-up will be less than six months
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 |
|---|---|---|
| Chart ReviewData between the years of 1/1/2002 and 12/31/2013 analyzed. | Other | Atypical Parathyroid Neoplasm, Parathyroid Carcinoma |
Primary outcome
Information Collected on Clinical Characteristics of Parathyroid (PTH) Cancer and PTH Atypical Neoplasms by Conducting a Retrospective Chart Review
Time frame: 5 years
Information Collected on PTH Carcinoma's Biological Behaviour and Impact on the Health of the Patients by Conducting a Retrospective Chart Review
Time frame: 5 years
Information Collected on Atypical Neoplasm's Biological Behaviour and Impact on the Health of the Patients \by Conducting a Retrospective Chart Review
Time frame: 5 years
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 7 Feb 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Parathyroid Carcinoma
RecruitingObservational study
Natural History Study of Parathyroid Disorders
Parathyroid Cancer, Primary Hyperparathyroidism
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Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Primary Hyperparathyroidism, Parathyroid Cancer
Active, not recruitingPhase 2
Agnostic Therapy in Rare Solid Tumors
Urachal Cancer, Parathyroid Carcinoma
Recruiting
Radiofrequency Ablation For Recurrent Parathyroid Carcinoma
Recurrent Parathyroid Carcinoma
Not yet recruitingPhase 2
Lenvatinib in Patients With Advanced Parathyroid Carcinoma
Parathyroid Carcinoma
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.
Nancy D. Perrier, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parathyroid Carcinoma and Parathyroid Neoplasm, run by M.D. Anderson Cancer Center 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 1 inclusion and 3 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 7 Feb 2018. 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?
Information Collected on Clinical Characteristics of Parathyroid (PTH) Cancer and PTH Atypical Neoplasms by Conducting a Retrospective Chart Review (time frame: 5 years). The study lists 3 primary outcomes in all. 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 7 Feb 2018.