Natural History Study of Parathyroid Disorders
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04969926 |
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Recruitment Status :
Recruiting
First Posted : July 21, 2021
Last Update Posted : May 13, 2024
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| Tracking Information | |||||||||
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| First Submitted Date | July 20, 2021 | ||||||||
| First Posted Date | July 21, 2021 | ||||||||
| Last Update Posted Date | May 13, 2024 | ||||||||
| Actual Study Start Date | November 30, 2021 | ||||||||
| Estimated Primary Completion Date | January 22, 2031 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
To develop a database and an annotated biospecimen repository for future research in disorders of bone and mineral metabolism and related disorders. [ Time Frame: 5 years ] Participants will undergo clinical evaluations according to standard clinical care for their condition. Data obtained during these evaluations will be retained for purposes of the primary objectives
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| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Natural History Study of Parathyroid Disorders | ||||||||
| Official Title | Natural History Study of Parathyroid Disorders | ||||||||
| Brief Summary | Background: Parathyroid disorders are very common in the general population and include disorders of parathyroid excess, deficiency, or defects in parathyroid hormone (PTH) signaling. PTH, the main secretory product of parathyroid glands is responsible for regulation of calcium-phosphate homeostasis. Objective: i) To investigate the cause of parathyroid disorders ii) To describe evolution, natural history, and longitudinal trends of parathyroid and related disorders seen in syndromic presentations like multiple endocrine neoplasia, hyperparathyroidism-jaw tumor syndrome Eligibility: People ages 6 months older who have, are at risk of having, or are related to a person with a parathyroid or related disorder. Design: Participants will be screened with a review of their medical records. Participants will be seen, tested, and treated by doctors based on their condition. Their visits may be in person or via telehealth. Participants will complete questionnaires. They will answer questions about their physical, mental, and social health. Participants may give samples such as saliva, blood, urine, or stool. Participants may give cheek cell samples. They will do this using a cheek swab or by spitting into a cup. Adult participants may give a skin biopsy. For this, a small bit of skin is removed with a punch tool. Participants may have medical photos taken. If participants have surgery during the course of their regular care either at the NIH or at a different hospital or doctor s office, researchers will ask for some of the leftover tissue. Participants will be in the study as long as they are being seen by their doctor. |
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| Detailed Description | Study Description: Patients with confirmed, suspected or at risk of developing parathyroid disorders will be provided standard of care testing for their condition. Data obtained during the testing will be used for research. Additionally, samples may be collected for research. Objectives:
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients with confirmed, suspected or at risk of developing parathyroid and related disorders. | ||||||||
| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Patients with confirmed, suspected or at risk of developing parathyroid disorder
Parathyroid (and related disorders) will be evaluated and their biospecimens collected to define the molecular signature and clinical spectrum of their disorder
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
3000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | January 22, 2031 | ||||||||
| Estimated Primary Completion Date | January 22, 2031 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study:
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| Sex/Gender |
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| Ages | 6 Months to 100 Years (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04969926 | ||||||||
| Other Study ID Numbers | 10000344 000344-DK |
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| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ) | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | May 8, 2024 | ||||||||