Sodium ThiosulfateNCT03979378
Treatment of Ectopic Calcification / Ossification With Sodium Thiosulfate (CATSSO)
An observational study of Sodium Thiosulfate and Ectopic Ossification, run by University Hospital, Limoges at 7 sites in France.
Trial summary
Ectopic calcification and ossification complicate many diseases, which are rare for the most part. These calcifications (or ossifications) are generally classified according to their apparent formation mechanism. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Sodium Thiosulfate, Ectopic Ossification
- How many people
- 120 participants
- Where
- 7 sitesFrance
- Study dates
- Feb 2015to Feb 2020
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient with ectopic calcification / ossification
Who may be able to join
- any patient treated with sodium thiosulfate dermally provided by the pharmacy of Limoges University Hospital.
- availability of an objective imaging evaluation to compare the volume or surface of calcifications (or ossifications) treated (on two orthogonal incidences) before and after 6 months of treatment application.
- consent to participation in the study signed by the patient or by one of the holders of parental authority in the case of a minor patient.
Who cannot join
- calcification with concomitant cutaneous rupture which can allow an externalization of the calcium material by mechanical effects.
- Patient with calcification secondary to one of the following pathologies:
- diabetes
- chronic renal failure
- iatrogenic origin
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Grenoble university hospital
Grenoble
Olivier CHABRE, MD, olivier.chabre@chu-grenoble.fr
Olivier CHABRE, MD
- Recruiting
Kremlin Bicetre Hospital
Le Kremlin-Bicêtre
Agnes Linglart, MD, agnes.linglart@aphp.fr
Agnes Linglart, MD
- Recruiting
CHU de Limoges
Limoges
Vincent GUIGONIS, MD, vincent.guigoni@unilim.fr
Claire BAHANS
- Recruiting
HEGP
Paris
Marie COURBEBAISSE, MD, marie.courbebaisse@aphp.fr
Marie COURBEBAISSE, MD
- Recruiting
Lariboisière Hospital
Paris
Korng EA, MD, korng.ea@aphp.fr
Korng EA, MD
- Recruiting
Necker Hospital
Paris
Christine BODEMER, MD, christine.bodemer@aphp.fr
Christine BODEMER, MD
- Recruiting
Robert Debré Hospital
Paris
Emmanuelle BOURRAT, emmanuelle.bourrat@aphp.fr
Emmanuelle BOURRAT, MD
About this study
Ectopic calcification and ossification complicate many diseases, which are rare for the most part. These calcifications (or ossifications) are generally classified according to their apparent formation mechanism. Even if very different diseases can be at the origin, these calcifications (or ossifications) have as common points: an unknown physiopathology, a composition of calcium pyrophosphate for the most part and l no curative treatment validated to date.
Indeed, although several reported cases suggest the potential efficacy of different treatments , none of these treatments is currently recognized as effective because of the absence of confirmation data or because of contradictory results.
Read more
Sodium thiosulfate (STS) has been used for a long time as an antidote to cyanide poisoning and as a protective agent against cytotoxic side effects such as ifosphamide. More recently, STS has been reported in the treatment of renal calcification. vascular or even subcutaneous. First prospective studies on animal models and in humans seem to confirm the interest of this product in the treatment of these abnormal calcifications.
For several months, a magistral preparation in the form of ointment based on STS has been developed by the pharmacy of Limoges University Hospital in order to combine the local effect of STS while avoiding the side effects of an administration of this treatment by systemic way. The first uses of this preparation appear promising and some preliminary results have already been published. The benefit / risk ratio of this approach seems to be advantageous for clinicians since preparations whose composition is close are currently validated by the FDA and the World Health Organisation for the treatment of benign pathologies such as cutaneous dermatophytes or pityriasis versicolor.
- Conditions
- Sodium Thiosulfate, Ectopic Ossification
- Medical subject headings
- Ossification, Heterotopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcification/Ossification volume
Percentage decrease in the volume or surface area of calcifications (or ossification) treated on imaging of the same type performed before and 6 months after dermal STS use.
Measured: Month 6
Secondary outcomes (4)
Change in aesthetic evolution from baseline at 6 month
aesthetic evolution on picture
Measured: Day 0, Month 6
Change in pain from baseline at 6 month
Evaluation of pain with scale VAE (visual analog evaluation)
Measured: Day 0, Month 6
Change of the quality of life from baseline at 6 month
evolution of the quality of life with Skindex scale
Measured: Day 0, Month 6
local or general side effects
Number and nature of local or general side effects
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study startFeb 2015
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium ThiosulfateStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979378
- Sponsor's protocol ID
- CATSSO
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Ectopic Calcification / Ossification With Sodium Thiosulfate (CATSSO)
- ClinicalTrials.gov ID
- NCT03979378
- Acronym / sponsor ID
- CATSSO
- Conditions
- Sodium Thiosulfate, Ectopic Ossification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 7 Jun 2019 (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.
Ectopic calcification and ossification complicate many diseases, which are rare for the most part. These calcifications (or ossifications) are generally classified according to their apparent formation mechanism. Even if very different diseases can be at the origin, these calcifications (or ossifications) have as common points: an unknown physiopathology, a composition of calcium pyrophosphate for the most part and l no curative treatment validated to date.
Indeed, although several reported cases suggest the potential efficacy of different treatments , none of these treatments is currently recognized as effective because of the absence of confirmation data or because of contradictory results.
Sodium thiosulfate (STS) has been used for a long time as an antidote to cyanide poisoning and as a protective agent against cytotoxic side effects such as ifosphamide. More recently, STS has been reported in the treatment of renal calcification. vascular or even subcutaneous. First prospective studies on animal models and in humans seem to confirm the interest of this product in the treatment of these abnormal calcifications.
For several months, a magistral preparation in the form of ointment based on STS has been developed by the pharmacy of Limoges University Hospital in order to combine the local effect of STS while avoiding the side effects of an administration of this treatment by systemic way. The first uses of this preparation appear promising and some preliminary results have already been published. The benefit / risk ratio of this approach seems to be advantageous for clinicians since preparations whose composition is close are currently validated by the FDA and the World Health Organisation for the treatment of benign pathologies such as cutaneous dermatophytes or pityriasis versicolor.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient with ectopic calcification / ossification
Key inclusion criteria (3 listed)
- any patient treated with sodium thiosulfate dermally provided by the pharmacy of Limoges University Hospital.
- availability of an objective imaging evaluation to compare the volume or surface of calcifications (or ossifications) treated (on two orthogonal incidences) before and after 6 months of treatment application.
- consent to participation in the study signed by the patient or by one of the holders of parental authority in the case of a minor patient.
Key exclusion criteria (5 listed)
- calcification with concomitant cutaneous rupture which can allow an externalization of the calcium material by mechanical effects.
- Patient with calcification secondary to one of the following pathologies:
- diabetes
- chronic renal failure
- iatrogenic origin
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
Calcification/Ossification volume
Time frame: Month 6
Percentage decrease in the volume or surface area of calcifications (or ossification) treated on imaging of the same type performed before and 6 months after dermal STS use.
4 secondary outcomes
Change in aesthetic evolution from baseline at 6 month
Time frame: Day 0, Month 6
Change in pain from baseline at 6 month
Time frame: Day 0, Month 6
Change of the quality of life from baseline at 6 month
Time frame: Day 0, Month 6
local or general side effects
Time frame: Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sodium Thiosulfate and Ectopic Ossification, run by University Hospital, Limoges at 7 sites 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 5 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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Calcification/Ossification volume (time frame: Month 6). 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 11 Jun 2019.