Differentially Expressed Proteins in Sporadic Parathyroid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Postgraduate Institute of Medical Education and Research
Sponsor:
Information provided by (Responsible Party):
Sanjay K. Bhadada, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01647503
First received: July 18, 2012
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition
Primary Hyperparathyroidism
Hypercalcemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Identification of Differentially Expressed Proteins in Parathyroid Tumors and Their Clinical Correlation With the Disease

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Differentially expressed proteins in parathyroid adenomas tissue samples [ Time Frame: At the end of three years of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tumor group
Parathyroid adenoma, hyperplasia and carcinoma
Normal
Normal parathyroid samples

Detailed Description:

Subjects:

All the PHPT patients attending outdoor patient clinic of Endocrinology and General Surgery department of Nehru Hospital, PGIMER, Chandigarh will be enrolled in this study.

Sample collection:

A parathyroid tissue sample will be taken from the patients undergoing for parathyroidectomy. Samples will be collected immediately after surgery, snap frozen and stored at -80oC until use. In addition 10 ml of blood will also be taken from these patients for estimating biochemical parameters.

Controls:

Normal parathyroid gland will be used as control and it will be obtained from patient undergoing thyroidectomy for multinodular goiter as an elective procedure at the institute.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Criteria

Inclusion Criteria:

  • PHPT patients with parathyroid adenoma, hyperplasia and carcinoma

Exclusion Criteria:

  • Patients with family history, HPT-JT syndrome and familial isolated hyperparathyroidism
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647503

Contacts
Contact: Sanjay Kr Bhadada, DM bhadadask@rediffmail.com
Contact: Ashutosh Kr Arya, M Sc aryan.hcu@gmail.com

Locations
India
PGIMER Recruiting
Chandigarh, UT, India, 1600012
Principal Investigator: Sanjay Kr Bhadada, DM         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Sanjay Kr Bhadada, DM Associate Professor, Department of Endocrinology, PGIMER Chandigarh India
  More Information

No publications provided

Responsible Party: Sanjay K. Bhadada, Associate Professor, Dept of Endocrinology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01647503     History of Changes
Other Study ID Numbers: parathyroid tumorigenesis
Study First Received: July 18, 2012
Last Updated: April 15, 2014
Health Authority: India: Indian Council of Medical Research

Keywords provided by Postgraduate Institute of Medical Education and Research:
parathyroid gland
primary hyperparathyroidism
proteins

Additional relevant MeSH terms:
Parathyroid Diseases
Hypercalcemia
Hyperparathyroidism
Parathyroid Neoplasms
Hyperparathyroidism, Primary
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on July 23, 2014