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New Biomarker-based Strategy to Screen and Monitor for Activated Phosphoinositide 3-kinase δ Syndrome

NCT06694363 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2026-03-23

No results posted yet for this study

Summary

The study would like to compare patient samples at different time points using state-of the art-phenotyping tools.

Collection of blood samples of APDS patients undergoing PI3K inhibitor treatment will be collected when feasible according to the standard of care planning (a blood test is supposed to be performed for these patients at M0-M3-M6-M12 then each 6 months for a total period of 2 years from the beginning of the PI3K inhibitor treatment).

The whole blood will be processed in order to isolate the peripheral blood mononuclear cells (PBMC) and the plasma. Serum, RNA and DNA extraction will be performed on a separate sample.

Conditions

  • Activated PI3K Delta Syndrome

Interventions

BIOLOGICAL

Blood samples

A maximum of 27 ml of blood collected at each visit for metabolic markers analysis

BIOLOGICAL

Urine samples

One urine sample collected at each visit for enteric virus infection research

BIOLOGICAL

Stool samples

One stool sample collected at each visit for enteric virus infection research

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Sven Kracker, PHD · Institut National de la Santé Et de la Recherche Médicale, France

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-26
Primary Completion
2029-06-27
Completion
2029-12-27

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06694363 on ClinicalTrials.gov