NCT01647503

Brief Summary

Primary hyperparathyroidism (PHPT) is one of the common endocrine disorders. The major clinical symptoms involve stones, bones, abdominal groans and psychiatric moans. Increased parathyroid cell proliferation and decreased calcium-mediated control of the PTH secretion are characteristic findings. The most common cause of PHPT is adenoma followed by hyperplasia and carcinoma.The molecular mechanisms involved in parathyroid tumorigenesis are partially known. Few genes have been identified and their roles are under study. The genes which are under study by different groups are unable to give a definite direction towards the understanding of parathyroid tumorigenesis and the mechanism involved in overgrowth of parathyroid tissue. So identifying different proteins and their regulation pattern from adenomas to carcinomas will be the initial steps towards understanding the proteins involved in tumorigenesis of parathyroid tissues. By using proteomics approach one can generate protein level information. In this study, using a combined approach based on 2 D gel electrophoresis and mass spectrometry (MS), the investigators propose to study a comparative proteomics to examine the changes of protein profiles in parathyroid tumor tissues with normal and hyperplasic parathyroid tissues. This work plan will help us to understand differentially expressed proteins in patients with PHPT. This will help in understanding the disease and identifying better diagnostic and curative measures of the disease. The investigators are also planning to access nuclear morphometry changes in sporadic parathyroid tumors. It will help in establishing cellular and nuclear change pattern variations from normal to parathyroid tumors.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2014

Enrollment Period

3.2 years

First QC Date

July 18, 2012

Last Update Submit

April 15, 2014

Conditions

Keywords

parathyroid glandprimary hyperparathyroidismproteins

Outcome Measures

Primary Outcomes (1)

  • Differentially expressed proteins in parathyroid adenomas tissue samples

    At the end of three years of the study

Study Arms (2)

Tumor group

Parathyroid adenoma, hyperplasia and carcinoma

Normal

Normal parathyroid samples

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients visiting the hospital for hypercalcemia, bone pain, renal problems and other symptoms related to primary hyperparathyroidim will be consider. Investigations and clinical symptoms will be confirmed for primary hyperpathyroidism. Finally if patient suggested for surgery then he will be included in the study

You may qualify if:

  • PHPT patients with parathyroid adenoma, hyperplasia and carcinoma

You may not qualify if:

  • Patients with family history, HPT-JT syndrome and familial isolated hyperparathyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, Uttarakhand, 1600012, India

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, PrimaryHypercalcemia

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Study Officials

  • Sanjay Kr Bhadada, DM

    Associate Professor, Department of Endocrinology, PGIMER Chandigarh India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjay Kr Bhadada, DM

CONTACT

Ashutosh Kr Arya, M Sc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Dept of Endocrinology

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 23, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2015

Last Updated

April 16, 2014

Record last verified: 2014-04

Locations