Matrix MetalloproteinaseNCT04801914
Enzyme Activity of Matrix Metalloproteinases in the Serum of Patients With Malignant Obstructive Hyperbilirubinemia Before and After PTBD
An observational study of Matrix Metalloproteinase, run by Institut za Rehabilitaciju Sokobanjska Beograd at 1 site in Serbia.
Trial summary
The purpose of this study is to detect differences in the enzymatic activity of matrix metalloproteinases in patients with malignant obstructive hyperbilirubinemia before and after percutaneous biliary drainage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Matrix Metalloproteinase
- What is being tested?
- Percutaneous biliary drainage
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSerbia
- Study dates
- 11 Dec 2020to 11 May 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with malignant obstructive hyperbilirubinemia admitted to hospital and referred to the interventional radiologist for percutaneous biliary drainage.
Who may be able to join
- pathological confirmation or imaging data confirming malignant disease causing bile duct obstruction, performance status 0-1
Who cannot join
- terminally ill patients, performance status >2, hepatic decompensation, severe underlying cardiac or renal diseases and coagulation disorders.
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
University Clinical Center of Serbia
Belgrade, 11000
Aleksandar N Filipovic, Dr, +381658832505, aleksandar.filipovic11@gmail.com
About this study
Official title: Influence of Percutaneous Biliary Drainage on the Change of Enzyme Activity of Matrix Metalloproteinases in the Serum of Patients With Malignant Obstructive Hyperbilirubinemia
The purpose of this study is to detect differences in the enzymatic activity of matrix metalloproteinases in patients with malignant obstructive hyperbilirubinemia before and after percutaneous biliary drainage.
Read the detailed description
This study will be designed as a prospective cohort study involving the collection of peripheral blood samples before and one month after percutaneous biliary drainage for further molecular biochemical analysis (measurement of serum matrix metalloproteinase activity). Biochemical analyzes are preceded by the entry of data relevant to the research (demographic, anamnestic, clinical and biochemical).
- Conditions
- Matrix Metalloproteinase
- Being tested
- Percutaneous biliary drainage
- Keywords
- biliary drainage, matrix metalloproteinases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous biliary drainageProcedure or surgery
Also called Matrix Metalloproteinase serum activity measurement
Collection of peripheral blood samples before and one month after percutaneous biliary drainage performed for patients with malignant obstructive hyperbilirubinemia for further molecular biochemical analysis (measurement of serum matrix metalloproteinase activity).
| Study group | Role | What they receive |
|---|---|---|
| Matrix Metalloproteinases | Value of serum matrix metalloproteinase activity before and one month after PTBD Receives: Procedure: Percutaneous biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMP-2 and MMP-9 serum activity
MMP serume activity will be measured by molecular biochemical analysis performed on peripheral blood samples taken before and one month after percutaneous biliary drainage
Measured: during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start11 Dec 2020
- Primary completion11 Mar 2021 (estimated)
- Study completion11 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Matrix MetalloproteinaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut za Rehabilitaciju Sokobanjska Beograd
- Sponsor type
- University, hospital or other
- Collaborators
- Klinički centar Srbije
- Responsible party
- Principal investigator, Tamara Filipovic, Institut za Rehabilitaciju Sokobanjska Beograd
- Investigators
- Kristina Gopcevic, Phd, Study director, Institute for chemistry in medicine, Medical school, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801914
- Sponsor's protocol ID
- 717/11
- Status last verified
- Mar 2021
- First submitted
- 13 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Percutaneous Biliary Drainage on the Change of Enzyme Activity of Matrix Metalloproteinases in the Serum of Patients With Malignant Obstructive Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT04801914
- Acronym / sponsor ID
- 717/11
- Conditions
- Matrix Metalloproteinase
- Keywords
- biliary drainage, matrix metalloproteinases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institut za Rehabilitaciju Sokobanjska BeogradUniversity, hospital or other
- Collaborators
- Klinički centar Srbije
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 11 Mar 2021 (estimated)
- Study completion
- 11 May 2021 (estimated)
- First posted
- 17 Mar 2021 (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 purpose of this study is to detect differences in the enzymatic activity of matrix metalloproteinases in patients with malignant obstructive hyperbilirubinemia before and after percutaneous biliary drainage.
Detailed description
This study will be designed as a prospective cohort study involving the collection of peripheral blood samples before and one month after percutaneous biliary drainage for further molecular biochemical analysis (measurement of serum matrix metalloproteinase activity). Biochemical analyzes are preceded by the entry of data relevant to the research (demographic, anamnestic, clinical and biochemical).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Matrix Metalloproteinases | – | Procedure: Percutaneous biliary drainageValue of serum matrix metalloproteinase activity before and one month after PTBD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant obstructive hyperbilirubinemia admitted to hospital and referred to the interventional radiologist for percutaneous biliary drainage.
Key inclusion criteria (1 listed)
- pathological confirmation or imaging data confirming malignant disease causing bile duct obstruction, performance status 0-1
Key exclusion criteria (1 listed)
- terminally ill patients, performance status >2, hepatic decompensation, severe underlying cardiac or renal diseases and coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous biliary drainageAlso: Matrix Metalloproteinase serum activity measurementCollection of peripheral blood samples before and one month after percutaneous biliary drainage performed for patients with malignant obstructive hyperbilirubinemia for further molecular biochemical analysis (measurement of serum matrix metalloproteinase activity). | Procedure or surgery | Matrix Metalloproteinases |
Primary outcome
MMP-2 and MMP-9 serum activity
Time frame: during intervention
MMP serume activity will be measured by molecular biochemical analysis performed on peripheral blood samples taken before and one month after percutaneous biliary drainage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Matrix Metalloproteinase
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
Not yet recruitingObservational study
Neurokinin A and Matrix Metalloproteinase 9 Levels in Gingival Crevicular Fluid Samples of Teeth With Symptomatic Irreversible Pulpitis With Symptomatic Apical Periodontitis
Symptomatic Irreversible Pulpitis With Apical Peridontitis
RecruitingObservational study
Association Between Periodontitis and Dry Eye Disease: A Cross-Sectional Study
Periodontitis, Dry Eye Disease (DED)
Not yet recruitingObservational study
Ultrasound Assessment of Sciatic Nerve and Inferior Gluteal Artery in Diabetic Peripheral Neuropathy(DPN): Association With a Target Gene
Diabetic Peripheral Neuropathy (DPN)
Recruiting
The Effects of Sodium Fluoride and Chlorhexidine Use on Salivary IL-6 and Matrix Metalloproteinase Levels in Children With Active Caries
Dental Caries, Dental Caries in Children
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.
Kristina Gopcevic, Phd study director
Institute for chemistry in medicine, Medical school, University of Belgrade
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 Matrix Metalloproteinase, run by Institut za Rehabilitaciju Sokobanjska Beograd at 1 site in Serbia.
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 17 Mar 2021. 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 Serbia. 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 Aleksandar N Filipovic, Dr (+381658832505, aleksandar.filipovic11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMP-2 and MMP-9 serum activity (time frame: during intervention). 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 Mar 2021.