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Active, not recruitingNCT06708689Updated Nov 27, 2024

Overview of Botriomycoma in Children with a Central Line: Epidemiology, Risk Factors, Treatments

An observational study in Home Parenteral Nutrition, Intestinal Failure and Central Line, sponsored by Hospices Civils de Lyon. Active, not recruiting at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
240
Ages
Up to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Home Parenteral Nutrition
  • Intestinal Failure
  • Central Line
  • Botriomycoma
  • Infection
  • Sepsis
  • Antibiotics
03

In context

Intestinal Failure

64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.

This study's enrollment of 240 is above the median of 60 across 19 observational studies indexed under Intestinal Failure.

Browse Intestinal Failure studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric patients with intestinal failures requiring a long-term central line for home parenteral nutrition in France

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • home parenteral nutrition patients
  • never diagnosed with an episode of botriomycoma on their central line
  • 0 to 18 years of age at diagnosis

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
240 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Appearance of Botryomycoma

    genetic characteristics (origin, phototype), local factors (mechanical, infectious), and general factors (history of sepsis).

    Time frame: From first diagnosis through a follow-up period of 2 years.

  2. Recurrence of Botryomycoma

    analyze risk factors for recurrence and evolution under different treatments.

    Time frame: From first diagnosis through a follow-up period of 2 years.

07

Study locations

1 site
  • Hôpital Mère-Enfant
    Bron, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Apr 2024, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2024
First posted
Nov 27, 2024
StartActual
Apr 1, 2022
Primary completionActual
Apr 1, 2024
CompletionEst.
Mar 3, 2025
Last update
Nov 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06708689
Responsible party
Sponsor
First posted
Nov 27, 2024
Start date
Apr 1, 2022
Primary completion
Apr 1, 2024
Completion
Mar 3, 2025 (estimated)
Last update
Nov 27, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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