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Lymphadenopathy study

Optimal diagnostics for timely recognition of suspected malignancy and avoiding unnecessary referral of benign causes in children with lymphadenopathy - Lymphadenopathy study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57739
Enrollment
440
Registered
2025-02-03
Start date
2025-10-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphadenopathy, malignant lymphoma Enlarged lymph nodes

Interventions

Not applicable.

Sponsors

Prinses Máxima Centrum voor Kinderoncologie
Lead Sponsor

Eligibility

Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: Reason of referral /hospital admission: lymphadenopathy Informed consent by patient and/or parent(s)/guardian(s) 

Exclusion criteria

Exclusion criteria: Gland(s) < 1 cm (exception: supraclavicular lymph nodes) Gland(s) spontaneously in regression at the time of first visit Clinical picture is consistent with lymphadenitis Swelling appears not to be a lymph node (for example, branchial cleft cyst or haemangioma) 

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this research is a machine learning diagnostic model for malignant lymphoma with a high specificity (85%+) for a minimum sensitivity (95%). The malignant lymphoma diagnosis will be confirmed by biopsy or excluded if there is an alternative diagnosis or spontaneous regression of the lymph node.

Secondary

MeasureTime frame
Additionally, we will make a separate model for a specific type of lymphoma (Nodular lymphocyte-predominant Hodgkin lymphoma). The third endpoint is a cost-effectiveness analysis. We will compare the costs and effects of the diagnostics tests using our model with standard care.

Countries

Netherlands

Contacts

Public ContactA. Beishuizen

Prinses Máxima Centrum voor Kinderoncologie

A.Beishuizen-2@prinsesmaximacentrum.nl088-972 72 72

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 10, 2026