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Status unknownNCT03093727Updated Aug 18, 2020

Characterization of Pulmonary Langerhans Cell Histiocytosis

An observational study in Langerhans Cell Histiocytoses, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2020-08-18.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Sex
All
01

Study summary

Very recent studies indicate that a high percentage of HCL, about 50%, have mutations in the B-RAF oncogene. The development of ultrasensitive methodologies capable of identifying these mutations in bronchoalveolar lavage will represent a significant advance in the diagnosis and treatment of these patients. An undetermined percentage of HCL does not present mutations in B-RAF. Consequently, the deep genetic analysis, through the use of techniques of massive sequencing, can favor the identification of new alterations that contribute to the development of the disease.

We hypothesized that patients with HCL may present a different inflammatory state to healthy subjects or smokers, allowing us to identify new biomarkers.

Read the detailed description

The main objective of this study is to expand the genetic and pathophysiological knowledge of this disease. For this, the following points will be developed:

  • Identification of mutations in the B-RAF oncogene in Spanish patients with pulmonary LCHF.
  • Development of ultrasensitive genetic analysis methods capable of identifying mutations in B-RAF in bronchoalveolar lavage (BAL) samples.
  • To determine if patients with mutations in the B-RAF oncogene present distinct clinical, radiological and / or functional characteristics compared to those with absence of the mutation.
  • Characterization of the inflammatory profile of patients with HPCL.
02

Conditions studied

  • Langerhans Cell Histiocytoses
03

In context

Histiocytosis, Langerhans-Cell

80 studies on the registry are indexed under Histiocytosis, Langerhans-Cell; 22 are open to participants now.

This study's planned enrollment of 20 is below the median of 97 across 14 observational studies indexed under Histiocytosis, Langerhans-Cell.

Browse Histiocytosis, Langerhans-Cell studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with Langerhans cell histiocytosis

Inclusion criteria

  • Men and women with no age limitation
  • Established histiological diagnosis of histiocytosis of langerhans cells.
  • HCLP-compatible clinical-radiological picture.
  • Signed informed consent

Exclusion criteria

Exclusion criteria

  • Non-acceptance of informed consent.
  • Absence in clinical history of clinical, radiological and functional variables essential for the diagnosis of HLCP.
  • Psychiatric disorder or limitation for study compression (including language, socio-cultural problem, etc.).
  • Radiological findings suggestive of another chronic lung disease.
  • Active respiratory infection.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Number of participants with mutations in the B-RAF oncogene in Langerhans histiocytosis

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08025, Spain
    • Claudia Erika Delgado Espinoza · Contact · CDelgadoE@santpau.cat
    • Diego Castillo, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03093727
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible party
Sponsor
First posted
Mar 28, 2017
Start date
Sep 27, 2013
Primary completion
Sep 2022 (estimated)
Completion
Sep 2023 (estimated)
Last update
Aug 18, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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