Menu
Recruiting NCT05761314

Solid Tumors in RASopathies

No phase Interventional RASopathy Costello Syndrome Cardio-Facio-Cutaneous Syndrome Noonan Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Molecular characterization of solid tumor in RASopathies.
Who it may be relevant to
Registry conditions: RASopathy, Costello Syndrome, Cardio-Facio-Cutaneous Syndrome, Noonan Syndrome. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Incidence and Molecular Pathogenesis of Solid Tumors in RASopathies

Overview

RASopathies are a group of syndromes, caused by variants of genes involved in the regulation of the Ras/MAP/ERK pathway. This intracellular transduction pathway profoundly affects embryogenic development, organogenesis, synaptic plasticity and neuronal growth. RASopathies are characterized by multi-organ involvement, growth delay, premature aging and haemato-oncological manifestations. Based on evidences provided by literature, cancer screening protocols are applied in some individuals affected by RASopathies, even though detailed information about prevalence and molecular pathogenesis of such tumors is still not clearly elucidate.

Detailed description

To define the prevalence of solid (non-haematological) neoplasms in a monocentric cohort of patients affected by RASopathies To perform Next Generation Sequencing (NGS) analysis on tissue samples to preliminarily characterize the molecular pathogenesis of solid tumors in these patients' categories.

Interventions

  • Diagnostic test Molecular characterization of solid tumor in RASopathies
    NGS analysis on tumor sample

Primary outcome measures

  • Prevalence of solid tumors in RASopathies [Time frame: 5 years]
Secondary outcome measures (1)
  • Molecular characterization of solid tumors in RASopathies [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Clinical and molecularly confirmed diagnosis of a RASopathy

Exclusion criteria

  • Clinical diagnosis of RASopathy without molecular characterization

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Italy · 1 center
  • Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, — Roma

Identifiers

NCT: NCT05761314 · 4218

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗