Home Parenteral NutritionNCT06708689
Overview of Botriomycoma in Children with a Central Line: Epidemiology, Risk Factors, Treatments
An observational study of Home Parenteral Nutrition and Intestinal Failure, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Botriomycomas are frequent benign tumors in children. Their appearance on the central catheter orifice is a known event in clinical practice, but one that has been little studied. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Home Parenteral Nutrition, Intestinal Failure, Central Line
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 3 Mar 2025
- 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 with intestinal failures requiring a long-term central line for home parenteral nutrition in France
Who may be able to join
- home parenteral nutrition patients
- never diagnosed with an episode of botriomycoma on their central line
- 0 to 18 years of age at diagnosis
Who cannot join
- Botriomycoma more than 10 years old at time of data collection (or lack of data)
- Patient over 18 years of age
- Not on home parenteral nutrition patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Case-control Study of Central Line Botriomycoma in Children on Home Parenteral Nutrition: Epidemiology, Risk Factors, Treatments
Botriomycomas are frequent benign tumors in children. Their appearance on the central catheter orifice is a known event in clinical practice, but one that has been little studied. This lesion could lead to changes in pathways and an increase in the number of sepsis events, which would promote thrombosis and thus depletion of venous capital in patients who have been dependent on a central line for many years.
This study is a pilot study which will enable us to better identify the risk factors for the development of such a tumour, and to take stock of the different treatments used and their respective efficacy.
- Conditions
- Home Parenteral Nutrition, Intestinal Failure, Central Line, Botriomycoma, Infection, Sepsis
- Medical subject headings
- Intestinal Failure, Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case / patients | Pediatric patients requiring a long-term central line for home parenteral nutrition: * home parenteral nutrition patients * diagnosed with at least on episode of botriomycoma on their central line * 0 to 18 years of age at diagnosis of botriomycoma | |
| Control | Pediatric patients requiring a long-term central line for home parenteral nutrition: * home parenteral nutrition patients * never diagnosed with an episode of botriomycoma on their central line * 0 to 18 years of age at diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of Botryomycoma
genetic characteristics (origin, phototype), local factors (mechanical, infectious), and general factors (history of sepsis).
Measured: From first diagnosis through a follow-up period of 2 years.
Recurrence of Botryomycoma
analyze risk factors for recurrence and evolution under different treatments.
Measured: From first diagnosis through a follow-up period of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Apr 2022
- Primary completion1 Apr 2024
- Study completion3 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home Parenteral NutritionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708689
- Sponsor's protocol ID
- 69HCL23_0638
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Case-control Study of Central Line Botriomycoma in Children on Home Parenteral Nutrition: Epidemiology, Risk Factors, Treatments
- ClinicalTrials.gov ID
- NCT06708689
- Acronym / sponsor ID
- 69HCL23_0638
- Conditions
- Home Parenteral Nutrition, Intestinal Failure, Central Line, Botriomycoma, Infection, Sepsis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 3 Mar 2025 (estimated)
- First posted
- 27 Nov 2024 (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.
Botriomycomas are frequent benign tumors in children. Their appearance on the central catheter orifice is a known event in clinical practice, but one that has been little studied. This lesion could lead to changes in pathways and an increase in the number of sepsis events, which would promote thrombosis and thus depletion of venous capital in patients who have been dependent on a central line for many years.
This study is a pilot study which will enable us to better identify the risk factors for the development of such a tumour, and to take stock of the different treatments used and their respective efficacy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case / patients | – | –Pediatric patients requiring a long-term central line for home parenteral nutrition: * home parenteral nutrition patients * diagnosed with at least on episode of botriomycoma on their central line * 0 to 18 years of age at diagnosis of botriomycoma |
| Control | – | –Pediatric patients requiring a long-term central line for home parenteral nutrition: * home parenteral nutrition patients * never diagnosed with an episode of botriomycoma on their central line * 0 to 18 years of age at diagnosis |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with intestinal failures requiring a long-term central line for home parenteral nutrition in France
Key inclusion criteria (3 listed)
- home parenteral nutrition patients
- never diagnosed with an episode of botriomycoma on their central line
- 0 to 18 years of age at diagnosis
Key exclusion criteria (3 listed)
- Botriomycoma more than 10 years old at time of data collection (or lack of data)
- Patient over 18 years of age
- Not on home parenteral nutrition patients
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
Appearance of Botryomycoma
Time frame: From first diagnosis through a follow-up period of 2 years.
genetic characteristics (origin, phototype), local factors (mechanical, infectious), and general factors (history of sepsis).
Recurrence of Botryomycoma
Time frame: From first diagnosis through a follow-up period of 2 years.
analyze risk factors for recurrence and evolution under different treatments.
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 27 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Home Parenteral Nutrition and Intestinal Failure, run by Hospices Civils de Lyon 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 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 27 Nov 2024. 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.
What does the primary outcome measure?
Appearance of Botryomycoma (time frame: From first diagnosis through a follow-up period of 2 years.). The study lists 2 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 27 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.