Hepatocyte Nuclear Factor 1-betaTCF2NCT00760331
Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function
An observational study of Hepatocyte Nuclear Factor 1-beta, run by University Hospital, Limoges at 1 site in France.
Trial summary
Anomalies of renal development are well know for patients treated for MODY-5 diabetes due to TCF2 mutation.A recent study confirms the existence of pediatric patients having TCF2 mutation but presenting renal anomalies alone.Endocrine and renal evolution of these patients is unknown.The aim of this study is to follow… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hepatocyte Nuclear Factor 1-beta
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients presenting an abnormality of kidney developmentdue to TCF2 mutation or deletion.
Who may be able to join
- Patients presenting an anomaly of renal development due to TCF2 mutation
- Age<18 years old
Who cannot join
- Anomaly of renal development without TCF2 mutation
- Age≥18 years old
- Parents or patients refusing to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function
Anomalies of renal development are well know for patients treated for MODY-5 diabetes due to TCF2 mutation.A recent study confirms the existence of pediatric patients having TCF2 mutation but presenting renal anomalies alone.Endocrine and renal evolution of these patients is unknown.The aim of this study is to follow a cohort of patients with TCF2 mutation and initially presenting renal anomalies alone.
Read the detailed description
Biologic analysis and renal ultrasonography once a year.
After puberty or before kidney transplantation
- Abdominal and pelvic MRI
- Intravenous Glucose Tolerance Test
- Conditions
- Hepatocyte Nuclear Factor 1-beta
- Keywords
- HNF1B, TCF2, MODY-5, CAKUT, Anomaly of renal development
- Medical subject headings
- Prostate Cancer, Hereditary, 11, Cakut
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2033 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocyte Nuclear Factor 1-betaStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent GUIGONIS, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760331
- Sponsor's protocol ID
- I06026
- Acronym
- TCF2
- Status last verified
- Feb 2015
- First submitted
- 25 Sep 2008
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function
- ClinicalTrials.gov ID
- NCT00760331
- Acronym / sponsor ID
- TCF2 / I06026
- Conditions
- Hepatocyte Nuclear Factor 1-beta
- Keywords
- HNF1B, TCF2, MODY-5, CAKUT, Anomaly of renal development
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jul 2033 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 26 Sep 2008 (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.
Anomalies of renal development are well know for patients treated for MODY-5 diabetes due to TCF2 mutation.A recent study confirms the existence of pediatric patients having TCF2 mutation but presenting renal anomalies alone.Endocrine and renal evolution of these patients is unknown.The aim of this study is to follow a cohort of patients with TCF2 mutation and initially presenting renal anomalies alone.
Detailed description
Biologic analysis and renal ultrasonography once a year.
After puberty or before kidney transplantation
- Abdominal and pelvic MRI
- Intravenous Glucose Tolerance Test
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients presenting an abnormality of kidney developmentdue to TCF2 mutation or deletion.
Key inclusion criteria (2 listed)
- Patients presenting an anomaly of renal development due to TCF2 mutation
- Age<18 years old
Key exclusion criteria (3 listed)
- Anomaly of renal development without TCF2 mutation
- Age≥18 years old
- Parents or patients refusing to participate to the study
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
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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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.
Vincent GUIGONIS, MD principal investigator
University Hospital, Limoges
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 Hepatocyte Nuclear Factor 1-beta, run by University Hospital, Limoges 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2018. 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?
This study is still under way. Results are not available in the source record yet.
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.
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 13 Aug 2018.