Malignant TumorFICTNCT02552381
Evaluation of Fibrin Structure Marker in Cancer Patients Treated and Not Treated With LMWH
An observational study of Malignant Tumor, run by Diagnostica Stago R&D at 1 site in France.
Trial summary
The purpose of the study is to assess the fibrin structure marker in the plasma of cancer patients, treated or not treated with LMWH at prophylactic or therapeutic doses, in order to determine the venous thromboembolic risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- Fibrin Structure
- How many people
- 389 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2015to 20 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from Internal Medicine Department, in a French Hospital
Who may be able to join
- patients with non-opposition to participate in the evaluation
- patients from Internal Medicine Department
- patients affected with all types of malignancies, treated or not with LMWH
Who cannot join
- patients treated with VKA or with recent surgery (within one month)
- patients with a condition known to cause a coagulation activation status other than cancer (sepsis, pneumonia,..)
Trial locations and contacts
1 site in 1 country.
France1 site
Internal Medecine Department - Adults Pole and Hematology Laboratory Hôpital Louis Mourier (AP-HP)
Colombes, 92701
About this study
The purpose of the study is to assess the fibrin structure marker in the plasma of cancer patients, treated or not treated with LMWH at prophylactic or therapeutic doses, in order to determine the venous thromboembolic risk. The occurrence of thromboembolic events in patients without treatment and in patients under LMWH treatment will be recorded, depending on the location and type of cancer, metastases, and treatment of cancer.
Read the detailed description
Rationale. Venous thromboembolism (VTE) is a major complication often encountered in oncology and onco-hematology, and difficult to handle. It involves the activation of coagulation with the generation of fibrin and plasmin and angiogenesis activation. Low molecular weight heparins (LMWH) are used to treat cancer associated thrombosis. Furthermore, they could have an inhibitory effect on tumor progression.
International recommendations on the treatment and prophylaxis of the disease allow a better management of VTE in patients with cancer. Its prevalence is high, occurring in 15-20% of the patients. It remains the second leading cause of death after cancer. LMWH at therapeutic dosage for at least three months and preferably six months without oral bridging is the reference treatment for VTE, which showed a 50% reduction in the risk of recurrent thromboembolism without increasing the hemorrhagic risk. In case of VTE recurrence under LMWH treatment, the dose can be increased by 10%. Preliminary results suggest that the fibrin structure marker would predict the hemorrhagic or thromboembolic risk, and show that LMWH has a dose-dependent effect on fibrin structure. This marker is evaluated as a tool to guide the treatment of VTE by LMWH in patients with cancer.
Main objective. To assess the fibrin structure marker in the plasma of cancer patients, treated or not treated with LMWH at prophylactic doses at enrollment or therapeutic doses, to determine the venous thromboembolic risk. The occurrence of thromboembolic events in patients without treatment or of recurrent thromboembolic events in patients under LMWH treatment will be studied, depending on the location and type of cancer, metastases, and treatment of cancer.
Patients. At least 300 adult patients over 18 years with all types of malignancies documented before or during therapeutic treatment with LMWH for thromboembolic event. They will be monitored every month in consultation or during hospitalization in the Internal Medicine Department. The patients under prophylaxis with LMWH at enrollment will also be included and classified in the group of prophylactic patients. The patients who receive prophylactic treatment during will be included and classified in the group of untreated patients.
Will not be included: patients with sepsis, severe infections, pneumonia, surgery, suspected thromboembolic event related to catheter implantation, vitamin K antagonists (VKA) in progress, and those with impossible follow-up.
The study is conducted in compliance with French regulation after ethics approval, the authorization for processing personal data (Commission Nationale de l'Informatique et des Libertés, 8, rue Vivienne CS 30223 75083 Paris Cedex 02) receipt number 1867686 v 0, date 18 June 2015.
Reference algorithm. Patients will be supported for the diagnosis and specific treatment of cancer (with or without metastases), according to the daily practice. The baseline risk score is the Khorana score of clinical probability, based on clinical criteria. A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker.
Biological parameters to be studied. The following tests will be carried out on frozen citrated plasma or serum, without knowledge of the clinical data and the conclusion of a diagnostic of thromboembolic event:
- Structure of the fibrin using coag-lysis method, measured at baseline and every month for all patients, by one site, using prototype assays
- Anti-FXa activity measured at baseline and every month only for patients treated with LMWH at therapeutic doses,
- FVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance, Fibrin assay for inflammation and hypercoagulation evaluation, all measured at baseline and every 3 months for all patients.
- Conditions
- Malignant Tumor
- Being tested
- Fibrin Structure
- Keywords
- Cancer, Thromboembolic event, Fibrin Structure, LMWH
- Medical subject headings
- Neoplasms, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin StructureOther
Modifications of Fibrin Structure in patients who have developed VTE in comparison with patients without VTE.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients without LMWH treatment.
A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker.
The following assays will be performed for these patients :
* Fibrin Structure measured at baseline and every month using prototype assays
* Other markers activity : sFVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months. Receives: Other: Fibrin Structure | |
| Group II | Patients with LMWH treatment at prophylactic dose at enrollment only.
A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker.
The following assays will be performed for these patients :
* Fibrin Structure measured at baseline and every month using prototype assays,
* Anti-FXa activity measured at baseline and every month,
* Other markers activity : FVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months. Receives: Other: Fibrin Structure | |
| Group III | Patients with LMWH treatment at therapeutic dose.
A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker.
The following assays will be performed for these patients :
* Fibrin Structure measured at baseline and every month using prototype assays,
* Anti-FXa activity measured at baseline and every month,
* Other markers activity : FVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months. Receives: Other: Fibrin Structure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic evolution of the optical density delta (ODD)
Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay.
Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
Measured: 36 Months
Secondary outcomes (4)
Clotting time (s)
Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay.
Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
Measured: 36 Months
Fibrin formation time (s)
Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay.
Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
Measured: 36 Months
Lysis time (s)
Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay.
Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
Measured: 36 Months
Duration and level of the plateau (s)
Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay.
Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startAug 2015
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malignant TumorStudies 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
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diagnostica Stago R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hôpital Louis Mourier, Hopital Lariboisière
- Responsible party
- Sponsor
- Investigators
- Isabelle Mahe, MD, PhD, Principal investigator, Université of Paris 7 - Paris DiderotGeneviève Contant, PhD, Study director, Diagnostica Stago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552381
- Sponsor's protocol ID
- FICT 2015-A00501-48
- Acronym
- FICT
- Status last verified
- Jan 2020
- First submitted
- 13 Aug 2015
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Meyer G. [Looking for the best molecule. A short history of anticoagulants]. Rev Mal Respir. 2011 Oct;28(8):951-3. doi: 10.1016/j.rmr.2011.09.006. Epub 2011 Oct 15. No abstract available. French.
PubMed 22099399Campbell RA, Aleman M, Gray LD, Falvo MR, Wolberg AS. Flow profoundly influences fibrin network structure: implications for fibrin formation and clot stability in haemostasis. Thromb Haemost. 2010 Dec;104(6):1281-4. doi: 10.1160/TH10-07-0442. Epub 2010 Sep 30. No abstract available.
PubMed 20886193Wolberg AS, Gabriel DA, Hoffman M. Analyzing fibrin clot structure using a microplate reader. Blood Coagul Fibrinolysis. 2002 Sep;13(6):533-9. doi: 10.1097/00001721-200209000-00008.
PubMed 12192305Varin R, Mirshahi S, Mirshahi P, Kierzek G, Sebaoun D, Mishal Z, Vannier JP, Yvonne Borg J, Simoneau G, Soria C, Soria J. Clot structure modification by fondaparinux and consequence on fibrinolysis: a new mechanism of antithrombotic activity. Thromb Haemost. 2007 Jan;97(1):27-31.
PubMed 17200767Pieters M, Philippou H, Undas A, de Lange Z, Rijken DC, Mutch NJ; Subcommittee on Factor XIII and Fibrinogen, and the Subcommittee on Fibrinolysis. An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: communication from the SSC of the ISTH. J Thromb Haemost. 2018 May;16(5):1007-1012. doi: 10.1111/jth.14002. Epub 2018 Apr 15. No abstract available.
PubMed 29658191Longstaff C; subcommittee on fibrinolysis. Development of Shiny app tools to simplify and standardize the analysis of hemostasis assay data: communication from the SSC of the ISTH. J Thromb Haemost. 2017 May;15(5):1044-1046. doi: 10.1111/jth.13656. Epub 2017 Mar 17. No abstract available.
PubMed 28304129
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fibrin Structure Marker in Cancer Patients Treated and Not Treated With LMWH
- ClinicalTrials.gov ID
- NCT02552381
- Acronym / sponsor ID
- FICT / FICT 2015-A00501-48
- Conditions
- Malignant Tumor
- Keywords
- Cancer, Thromboembolic event, Fibrin Structure, LMWH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Diagnostica Stago R&DIndustry (pharma, biotech, devices)
- Collaborators
- Hôpital Louis Mourier, Hopital Lariboisière
- Study start
- Aug 2015
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 17 Sep 2015 (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.
The purpose of the study is to assess the fibrin structure marker in the plasma of cancer patients, treated or not treated with LMWH at prophylactic or therapeutic doses, in order to determine the venous thromboembolic risk. The occurrence of thromboembolic events in patients without treatment and in patients under LMWH treatment will be recorded, depending on the location and type of cancer, metastases, and treatment of cancer.
Detailed description
Rationale. Venous thromboembolism (VTE) is a major complication often encountered in oncology and onco-hematology, and difficult to handle. It involves the activation of coagulation with the generation of fibrin and plasmin and angiogenesis activation. Low molecular weight heparins (LMWH) are used to treat cancer associated thrombosis. Furthermore, they could have an inhibitory effect on tumor progression.
International recommendations on the treatment and prophylaxis of the disease allow a better management of VTE in patients with cancer. Its prevalence is high, occurring in 15-20% of the patients. It remains the second leading cause of death after cancer. LMWH at therapeutic dosage for at least three months and preferably six months without oral bridging is the reference treatment for VTE, which showed a 50% reduction in the risk of recurrent thromboembolism without increasing the hemorrhagic risk. In case of VTE recurrence under LMWH treatment, the dose can be increased by 10%. Preliminary results suggest that the fibrin structure marker would predict the hemorrhagic or thromboembolic risk, and show that LMWH has a dose-dependent effect on fibrin structure. This marker is evaluated as a tool to guide the treatment of VTE by LMWH in patients with cancer.
Main objective. To assess the fibrin structure marker in the plasma of cancer patients, treated or not treated with LMWH at prophylactic doses at enrollment or therapeutic doses, to determine the venous thromboembolic risk. The occurrence of thromboembolic events in patients without treatment or of recurrent thromboembolic events in patients under LMWH treatment will be studied, depending on the location and type of cancer, metastases, and treatment of cancer.
Patients. At least 300 adult patients over 18 years with all types of malignancies documented before or during therapeutic treatment with LMWH for thromboembolic event. They will be monitored every month in consultation or during hospitalization in the Internal Medicine Department. The patients under prophylaxis with LMWH at enrollment will also be included and classified in the group of prophylactic patients. The patients who receive prophylactic treatment during will be included and classified in the group of untreated patients.
Will not be included: patients with sepsis, severe infections, pneumonia, surgery, suspected thromboembolic event related to catheter implantation, vitamin K antagonists (VKA) in progress, and those with impossible follow-up.
The study is conducted in compliance with French regulation after ethics approval, the authorization for processing personal data (Commission Nationale de l'Informatique et des Libertés, 8, rue Vivienne CS 30223 75083 Paris Cedex 02) receipt number 1867686 v 0, date 18 June 2015.
Reference algorithm. Patients will be supported for the diagnosis and specific treatment of cancer (with or without metastases), according to the daily practice. The baseline risk score is the Khorana score of clinical probability, based on clinical criteria. A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker.
Biological parameters to be studied. The following tests will be carried out on frozen citrated plasma or serum, without knowledge of the clinical data and the conclusion of a diagnostic of thromboembolic event:
- Structure of the fibrin using coag-lysis method, measured at baseline and every month for all patients, by one site, using prototype assays
- Anti-FXa activity measured at baseline and every month only for patients treated with LMWH at therapeutic doses,
- FVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance, Fibrin assay for inflammation and hypercoagulation evaluation, all measured at baseline and every 3 months for all patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: Fibrin StructurePatients without LMWH treatment. A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker. The following assays will be performed for these patients : * Fibrin Structure measured at baseline and every month using prototype assays * Other markers activity : sFVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months. |
| Group II | – | Other: Fibrin StructurePatients with LMWH treatment at prophylactic dose at enrollment only. A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker. The following assays will be performed for these patients : * Fibrin Structure measured at baseline and every month using prototype assays, * Anti-FXa activity measured at baseline and every month, * Other markers activity : FVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months. |
| Group III | – | Other: Fibrin StructurePatients with LMWH treatment at therapeutic dose. A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker. The following assays will be performed for these patients : * Fibrin Structure measured at baseline and every month using prototype assays, * Anti-FXa activity measured at baseline and every month, * Other markers activity : FVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Internal Medicine Department, in a French Hospital
Key inclusion criteria (3 listed)
- patients with non-opposition to participate in the evaluation
- patients from Internal Medicine Department
- patients affected with all types of malignancies, treated or not with LMWH
Key exclusion criteria (2 listed)
- patients treated with VKA or with recent surgery (within one month)
- patients with a condition known to cause a coagulation activation status other than cancer (sepsis, pneumonia,..)
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 |
|---|---|---|
| Fibrin StructureModifications of Fibrin Structure in patients who have developed VTE in comparison with patients without VTE. | Other | Group I, Group II, Group III |
Primary outcome
Dynamic evolution of the optical density delta (ODD)
Time frame: 36 Months
Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay. Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
4 secondary outcomes
Clotting time (s)
Time frame: 36 Months
Fibrin formation time (s)
Time frame: 36 Months
Lysis time (s)
Time frame: 36 Months
Duration and level of the plateau (s)
Time frame: 36 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 22099399Meyer G. [Looking for the best molecule. A short history of anticoagulants]. Rev Mal Respir. 2011 Oct;28(8):951-3. doi: 10.1016/j.rmr.2011.09.006. Epub 2011 Oct 15. No abstract available. French.
- Background: PubMed 20886193Campbell RA, Aleman M, Gray LD, Falvo MR, Wolberg AS. Flow profoundly influences fibrin network structure: implications for fibrin formation and clot stability in haemostasis. Thromb Haemost. 2010 Dec;104(6):1281-4. doi: 10.1160/TH10-07-0442. Epub 2010 Sep 30. No abstract available.
- Background: PubMed 12192305Wolberg AS, Gabriel DA, Hoffman M. Analyzing fibrin clot structure using a microplate reader. Blood Coagul Fibrinolysis. 2002 Sep;13(6):533-9. doi: 10.1097/00001721-200209000-00008.
- Background: PubMed 17200767Varin R, Mirshahi S, Mirshahi P, Kierzek G, Sebaoun D, Mishal Z, Vannier JP, Yvonne Borg J, Simoneau G, Soria C, Soria J. Clot structure modification by fondaparinux and consequence on fibrinolysis: a new mechanism of antithrombotic activity. Thromb Haemost. 2007 Jan;97(1):27-31.
- Background: PubMed 29658191Pieters M, Philippou H, Undas A, de Lange Z, Rijken DC, Mutch NJ; Subcommittee on Factor XIII and Fibrinogen, and the Subcommittee on Fibrinolysis. An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: communication from the SSC of the ISTH. J Thromb Haemost. 2018 May;16(5):1007-1012. doi: 10.1111/jth.14002. Epub 2018 Apr 15. No abstract available.
- Background: PubMed 28304129Longstaff C; subcommittee on fibrinolysis. Development of Shiny app tools to simplify and standardize the analysis of hemostasis assay data: communication from the SSC of the ISTH. J Thromb Haemost. 2017 May;15(5):1044-1046. doi: 10.1111/jth.13656. Epub 2017 Mar 17. No abstract available.
- Recommandations internationales pour le traitement et la prophylaxie de la thromboembolie veineuse chez le patient cancéreux. GFTC, Communiqué de presse, 26 Juin 2013Link provided by the sponsor.
- Patent : Juillet 2015, Method for determining the structural profile of a fibrin clot reflecting the stability thereof, in order to predict the risk of bleeding, thrombosis or rethrombosisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Isabelle Mahe, MD, PhD principal investigator
Université of Paris 7 - Paris Diderot
Geneviève Contant, PhD study director
Diagnostica Stago
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 Malignant Tumor, run by Diagnostica Stago R&D at 1 site in France.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 Jan 2020. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic evolution of the optical density delta (ODD) (time frame: 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02552381, which also lists 6 linked publications.
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 7 Jan 2020.