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NCT Number: NCT06708689

Overview of Botriomycoma in Children with a Central Line: 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Retrospective Case-control Study of Central Line Botriomycoma in Children on Home Parenteral Nutrition: Epidemiology, Risk Factors, Treatments

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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