Natural History Study of Parathyroid Disorders
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| ClinicalTrials.gov Identifier: NCT04969926 |
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Recruitment Status :
Recruiting
First Posted : July 21, 2021
Last Update Posted : April 26, 2024
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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.
| Condition or disease |
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| Parathyroid Cancer Primary Hyperparathyroidism Pseudohypoparathyroidism Inheritable Bone Diseases Multiple Endocrine Neoplasia, Type 1 |
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:
- To investigate the cause of the disease and its associated manifestations, possibly genetic in participants with parathyroid and related disorder(s)
- To identify biomarkers of the various parathyroid disorder(s) and associated manifestations by performing molecular profiling of available biospecimens
- To describe evolution, natural history and longitudinal trends of parathyroid and related disorders including the associated extra- parathyroid manifestations seen in these disorders, for example, Zollinger-Ellison syndrome, gastro-entero-pancreatic neuroendocrine tumors, kidney, jaw, pituitary and uterine tumors.
- To investigate the natural history of parathyroid disorders and associated manifestations during pregnancy
- To characterize the morbidity and mortality in participants with parathyroid and related disorders and investigate its association with extra-parathyroidal manifestations.
- To investigate long-term risks and benefits with standard of care testing and therapy for parathyroid and associated extra-parathyroidal manifestations.
| Study Type : | Observational |
| Estimated Enrollment : | 3000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Natural History Study of Parathyroid Disorders |
| Actual Study Start Date : | November 30, 2021 |
| Estimated Primary Completion Date : | January 22, 2031 |
| Estimated Study Completion Date : | January 22, 2031 |
| Group/Cohort |
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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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- To identify biomarkers of the disease and associated manifestations by performing molecular profiling of available biospecimens [ Time Frame: 5 years ]Participants will undergo standard clinical evaluations for their condition. Data obtained during these evaluations will be retained for purposes of the primary objective, for analysis of secondary objectives, and for future research. There are no mandatory study procedures for this protocol.
- To investigate the cause and molecular mechanism of the disease, possibly genetic in participants with unknown cause of parathyroid and related disorder(s) [ Time Frame: 5 years ]Participants will undergo standard clinical evaluations for their condition. Data obtained during these evaluations will be retained for purposes of the primary objective, for analysis of secondary objectives, and for future research. There are no mandatory study procedures for this protocol.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 6 Months to 100 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Subjects known to have, suspected of having, or at risk of developing a parathyroid or related disorder.
- Age >= 6 months.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Children <= 6 months
- Patients with conditions that in the opinion of the investigators can interfere with the study objectives.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969926
| Contact: Craig S Cochran, R.N. | (301) 402-1880 | craigc@bdg10.niddk.nih.gov | |
| Contact: Smita Jha, M.D. | (301) 827-1930 | smita.jha@nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 ccopr@nih.gov | |
| Principal Investigator: | Smita Jha, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT04969926 |
| Other Study ID Numbers: |
10000344 000344-DK |
| First Posted: | July 21, 2021 Key Record Dates |
| Last Update Posted: | April 26, 2024 |
| Last Verified: | April 19, 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hyperparathyroidism calcium disorders Parathyroid Cancer |
Inheritable PSEUDOHYPOPARATHYROIDISM Natural History |
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Endocrine Gland Neoplasms Multiple Endocrine Neoplasia Parathyroid Neoplasms Multiple Endocrine Neoplasia Type 1 Bone Diseases Pseudohypoparathyroidism Pseudopseudohypoparathyroidism Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases Neoplasms Endocrine System Diseases |
Musculoskeletal Diseases Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Bone Diseases, Metabolic Metal Metabolism, Inborn Errors Metabolism, Inborn Errors Metabolic Diseases Calcium Metabolism Disorders Head and Neck Neoplasms |