Genotype-related Molecular Targets in the Vitamin D Pathway for Spinal Disc Diseases (GenVDisc)

November 10, 2017 updated by: Istituto Ortopedico Galeazzi

Identification of Genotype-related Molecular Targets in the Vitamin D Pathway for Personalized Pharmacological Treatments of the Spinal Disc Diseases

The objective of our study will be to analyze the interplay between particular VDR variants and its ligand in cells obtained from intervertebral disc and cartilage endplate and their action on cell proliferation and phenotype maintenance. The identification of novel molecular targets in the vitamin D pathway, potentially promoting pathological alterations of the tissues involved in spinal disc diseases, will allow to develop innovative and more personalized preventive and pharmacological/nutritional therapies.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with spinal disc diseases

Description

Inclusion Criteria:

patients with spinal disc diseases

  • males and females
  • 18≤age ≤ 70 years old
  • Italian white
  • patients with spinal disc diseases that will be surgically treated

Exclusion criteria:

- age < 18 or > 70 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phenotype and genotype characterization
Time Frame: 1 year
To evaluate structural alterations of the intervertebral disc and of the cartilage endplate in patients with spinal disc diseases related to functional FokI polymorphism in the vitamin D receptor (VDR) gene.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disc cell functional response genotype-based
Time Frame: 2 years
To characterize cells obtained from different disc tissues (nucleus pulposus, annulus fibrosus, cartilage endplate) and to evaluate their VDR FokI genotype-related response to vitamin D treatment, regulating the cell proliferation and phenotype.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2016

Primary Completion (Anticipated)

February 17, 2018

Study Completion (Anticipated)

February 17, 2019

Study Registration Dates

First Submitted

November 10, 2017

First Submitted That Met QC Criteria

November 10, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GenVDisc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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