Intervertebral Disk DegenerationGenVDiscNCT03343899
Genotype-related Molecular Targets in the Vitamin D Pathway for Spinal Disc Diseases
An observational study of Intervertebral Disk Degeneration, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intervertebral Disk Degeneration
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 17 Feb 2016to 17 Feb 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with spinal disc diseases
Who may be able to join
- 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
Who cannot join
- age < 18 or > 70 years old
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Alessandra Colombini
Milan, 20161
Alessandra Colombini, +390266214067, alessandra.colombini@grupposandonato.it
About this study
Official title: 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.
- Conditions
- Intervertebral Disk Degeneration
- Medical subject headings
- Intervertebral Disc Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotype and genotype characterization
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.
Measured: 1 year
Secondary outcomes (1)
Disc cell functional response genotype-based
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start17 Feb 2016
- Primary completion17 Feb 2018 (estimated)
- Study completion17 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disk DegenerationStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343899
- Sponsor's protocol ID
- GenVDisc
- Acronym
- GenVDisc
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genotype-related Molecular Targets in the Vitamin D Pathway for Personalized Pharmacological Treatments of the Spinal Disc Diseases
- ClinicalTrials.gov ID
- NCT03343899
- Acronym / sponsor ID
- GenVDisc / GenVDisc
- Conditions
- Intervertebral Disk Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 17 Feb 2016 (actual)
- Primary completion
- 17 Feb 2018 (estimated)
- Study completion
- 17 Feb 2019 (estimated)
- First posted
- 17 Nov 2017 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with spinal disc diseases
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- age < 18 or > 70 years old
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
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 secondary outcome
Disc cell functional response genotype-based
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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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.
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 Intervertebral Disk Degeneration, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 5 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 17 Nov 2017. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotype and genotype characterization (time frame: 1 year). 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 17 Nov 2017.