Primary HyperparathyroidismNCT01647503
Differentially Expressed Proteins in Sporadic Parathyroid Tumors
An observational study of Primary Hyperparathyroidism and Hypercalcemia, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Primary Hyperparathyroidism, Hypercalcemia
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2012to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- PHPT patients with parathyroid adenoma, hyperplasia and carcinoma
Who cannot join
- Patients with family history, HPT-JT syndrome and familial isolated hyperparathyroidism
Trial locations and contacts
1 site in 1 country.
Sanjay Kr Bhadada, DM contact
Ashutosh Kr Arya, M Sc contact
India1 site, 1 recruiting
- Recruiting
PGIMER
Chandigarh, Uttarakhand, 1600012
Sanjay Kr Bhadada, DM
About this study
Official title: Identification of Differentially Expressed Proteins in Parathyroid Tumors and Their Clinical Correlation With the Disease
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.
Read the 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.
- Conditions
- Primary Hyperparathyroidism, Hypercalcemia
- Keywords
- parathyroid gland, primary hyperparathyroidism, proteins
- Medical subject headings
- Hyperparathyroidism, Primary, Hypercalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tumor group | Parathyroid adenoma, hyperplasia and carcinoma | |
| Normal | Normal parathyroid samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentially expressed proteins in parathyroid adenomas tissue samples
Measured: At the end of three years of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay K. Bhadada, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Sanjay Kr Bhadada, DM, Principal investigator, Associate Professor, Department of Endocrinology, PGIMER Chandigarh India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647503
- Sponsor's protocol ID
- parathyroid tumorigenesis
- Status last verified
- Apr 2014
- First submitted
- 18 Jul 2012
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Differentially Expressed Proteins in Parathyroid Tumors and Their Clinical Correlation With the Disease
- ClinicalTrials.gov ID
- NCT01647503
- Acronym / sponsor ID
- parathyroid tumorigenesis
- Conditions
- Primary Hyperparathyroidism, Hypercalcemia
- Keywords
- parathyroid gland, primary hyperparathyroidism, proteins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2015 (estimated)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor group | – | –Parathyroid adenoma, hyperplasia and carcinoma |
| Normal | – | –Normal parathyroid samples |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- PHPT patients with parathyroid adenoma, hyperplasia and carcinoma
Key exclusion criteria (1 listed)
- Patients with family history, HPT-JT syndrome and familial isolated hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differentially expressed proteins in parathyroid adenomas tissue samples
Time frame: At the end of three years of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Kr Bhadada, DM contact
Ashutosh Kr Arya, M Sc contact
Sanjay Kr Bhadada, DM principal investigator
Associate Professor, Department of Endocrinology, PGIMER Chandigarh India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism and Hypercalcemia, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjay Kr Bhadada, DM (bhadadask@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentially expressed proteins in parathyroid adenomas tissue samples (time frame: At the end of three years of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2014.