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Gene Expression in Hyperparathyroidism

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044600
Recruitment Status : Terminated (At the request of the Principal Investigator)
First Posted : February 7, 2017
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Objectives:

  1. To better define the differences in molecular genetics of parathyroid tumors in patients with MEN1, single gland parathyroid disease in patients less than 50 years old and single gland disease in patients greater than 50 years old.
  2. To better define the incidence of HRPT2 mutation in young patients with primary hyperparathyroidism and determine whether routine testing in these patients is indicated.

Condition or disease Intervention/treatment
Parathyroid Disease Hyperparathyroidism Other: Chart Review Other: HRPT2 Mutation Evaluation

Detailed Description:
Patient charts will be reviewed to collect demographic data, pre-operative and post-operative clinical and laboratory data, operative reports, and pathology reports. Archived formalin-fixed paraffin-embedded (FFPE) tissue blocks from surgical specimens of patients will be stained for parafibromin to evaluate for HRPT2 mutations.

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression in Hyperparathyroidism: Identifying Molecular Differences in MEN1 Patients Versus Young MEN1 Negative Patients
Actual Study Start Date : November 7, 2012
Actual Primary Completion Date : October 18, 2017
Actual Study Completion Date : October 18, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Young MEN1 Negative Group
Participants under 50 years of age who have been diagnosed with MEN1-negative primary hyperparathyroidism.
Other: Chart Review
Patient charts will be reviewed to collect demographic data, pre-operative and post-operative clinical and laboratory data, operative reports, and pathology reports.

Other: HRPT2 Mutation Evaluation
Archived formalin-fixed paraffin-embedded (FFPE) tissue blocks from surgical specimens of patients stained for parafibromin to evaluate for HRPT2 mutations.




Primary Outcome Measures :
  1. Molecular Genetics of Parathyroid Tumors [ Time Frame: 10 years ]
    RNA isolated from banked frozen tissues. cDNA microarray prepared using an Illumina array chip. Results analyzed using Ingenuity analysis software to detect 2-fold changes in gene expression. T-statistics used to determine significantly discriminating genes.


Secondary Outcome Measures :
  1. HRPT2 Mutations [ Time Frame: 10 years ]
    Archived formalin-fixed paraffin-embedded (FFPE) tissue blocks from surgical specimens of patients stained for parafibromin to evaluate for HRPT2 mutations.


Biospecimen Retention:   Samples With DNA
Parathyroid tissue previously obtained during surgery.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with parathyroid tumors at MD Anderson Cancer Center
Criteria

Inclusion Criteria:

  1. All patients previously enrolled in parathyroid tissue banking under protocol Lab08-0034.
  2. For the subgroup designated for HRPT2 mutation testing:

Patients with primary hyperparathyroidism who are younger than 50 years of age and have tested negative for MEN1, between January 1, 1980 and the present.

Exclusion Criteria:

N/A


Information from the National Library of Medicine

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): NCT03044600


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Nancy D. Perrier, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03044600    
Other Study ID Numbers: PA12-0944
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Parathyroid disease
Hyperparathyroidism
Chart review
MEN1-negative
HRPT2 mutations
Additional relevant MeSH terms:
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Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases