CholestasisCHOLESTASENCT02767648
Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region
An observational study of Cholestasis, run by University Hospital, Toulouse at 4 sites in France.
Trial summary
The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Cholestasis
- What is being tested?
- proteomic urine analysis
- How many people
- 57 participants
- Where
- 4 sitesFrance
- Study dates
- May 2010to Oct 2013
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: infant suffering from cholestasis
Who may be able to join
- Infant <1 year suffering from cholestasis
Who cannot join
- Rejection or inability for parent to give their informed consent
Trial locations and contacts
4 sites in 1 country.
France4 sites
UH Bordeaux
Bordeaux
UH Limoges
Limoges
UH Montpellier
Montpellier, 34000
UH Toulouse
Toulouse, 31000
About this study
The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.
- Conditions
- Cholestasis
- Being tested
- proteomic urine analysis
- Keywords
- cholestasis, neonatal, infant
- Medical subject headings
- Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proteomic urine analysisOther
proteomic urine analysis
| Study group | Role | What they receive |
|---|---|---|
| cholestasis | infant suffering from cholestasis proteomic urine analysis Receives: Other: proteomic urine analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gathering mother epidemiologic characteristics as assessed by pregancy informations collection
Date of child birth, course of pregnancy, occurrence of twin pregnancy, serology abnormalities, family background of liver desease, course of previous pregnancies
Measured: Day 1 (inclusion)
Gathering new born epidemiologic characteristics as assessed by birth informations collection
Birth anamnesis, inclusion age, hepatic desease history, hemostasis workup, validated etiologic diagnosis and criteria for the diagnosis, specific and non-specific therapeutic care
Measured: Day 1 (inclusion)
Epidemiologic characteristics follow up as assessed by medical monitoring
Desease evolution in the first year of life, clinical evaluation, biological evaluation, final diagnosis, complications of the sickness, existence of transplatation, death
Measured: When children are between 12 and 18 months old
Secondary outcomes (3)
Homogenization of diagnosis and treatment of new born with the constitution and follow up of a prospective cohorte
Homogenize the care pathway of neonatal and infant cholestasis
Measured: Up to 3 years
Extend the study to the national french territory using the hepatology association network
Use this study to start a national study
Measured: Up to 3 years
Identification of proteomic profiles using the biologic collection gathered in the cohorte population
Identify one or more specific proteomic profile of neonatal cholestasis
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMay 2010
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholestasisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Broue, MD, Principal investigator, UH ToulouseThierry Lamireau, MD, Principal investigator, University Hospital, BordeauxJane Languepin, MD, Principal investigator, UH LimogesSebastien Fournier-Favre, MD, Principal investigator, UH Monptellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767648
- Sponsor's protocol ID
- 08 030 08
- Other IDs
- 2008
- Acronym
- CHOLESTASE
- Status last verified
- May 2016
- First submitted
- 10 Jul 2015
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region
- ClinicalTrials.gov ID
- NCT02767648
- Acronym / sponsor ID
- CHOLESTASE / 08 030 08
- Conditions
- Cholestasis
- Keywords
- cholestasis, neonatal, infant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 May 2016 (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 goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cholestasis | – | Other: proteomic urine analysisinfant suffering from cholestasis proteomic urine analysis |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infant suffering from cholestasis
Key inclusion criteria (1 listed)
- Infant <1 year suffering from cholestasis
Key exclusion criteria (1 listed)
- Rejection or inability for parent to give their informed consent
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 |
|---|---|---|
| proteomic urine analysisproteomic urine analysis | Other | cholestasis |
Primary outcome
Gathering mother epidemiologic characteristics as assessed by pregancy informations collection
Time frame: Day 1 (inclusion)
Date of child birth, course of pregnancy, occurrence of twin pregnancy, serology abnormalities, family background of liver desease, course of previous pregnancies
Gathering new born epidemiologic characteristics as assessed by birth informations collection
Time frame: Day 1 (inclusion)
Birth anamnesis, inclusion age, hepatic desease history, hemostasis workup, validated etiologic diagnosis and criteria for the diagnosis, specific and non-specific therapeutic care
Epidemiologic characteristics follow up as assessed by medical monitoring
Time frame: When children are between 12 and 18 months old
Desease evolution in the first year of life, clinical evaluation, biological evaluation, final diagnosis, complications of the sickness, existence of transplatation, death
3 secondary outcomes
Homogenization of diagnosis and treatment of new born with the constitution and follow up of a prospective cohorte
Time frame: Up to 3 years
Extend the study to the national french territory using the hepatology association network
Time frame: Up to 3 years
Identification of proteomic profiles using the biologic collection gathered in the cohorte population
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
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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.
Pierre Broue, MD principal investigator
UH Toulouse
Thierry Lamireau, MD principal investigator
University Hospital, Bordeaux
Jane Languepin, MD principal investigator
UH Limoges
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholestasis, run by University Hospital, Toulouse at 4 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 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: stopped early, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
Gathering mother epidemiologic characteristics as assessed by pregancy informations collection (time frame: Day 1 (inclusion)). The study lists 3 primary outcomes in all. 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 10 May 2016.