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Minimal residual disease monitoring in PTLD

Response assessment in post-transplant lymphoproliferative disorder with 18F-FDG-PET/CT and minimal residual disease monitoring, a multicenter multinational feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22796
Enrollment
30
Registered
2018-07-23
Start date
2018-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Circulating tumor DNA Post-transplant lymphoproliferative disorder 18F-flurodeoxyglucose positron emission tomography/computed tomography Minimal residual disease

Interventions

None

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Patients having undergone a SOT or HSCT - Histologically proven CD20+ monomorphic PTLD (with or without EBV association), - Age > 18 years - Intent to treat patient according to standard protocol (rituximab / R-CHOP). Clinicians are allowed to adapt protocol in the best interest of the patient - Measurable disease on 18F-FDG-PET/CT at diagnosis according to the Lugano classification 2014 - Patient’s written informed consent and written consent for data collection.

Exclusion criteria

Exclusion criteria: - A complete surgical resection of tumor. - Upfront treatment with external beam radiation therapy. - Involvement of the central nervous system by the disease. - Known to be HIV positive. - Iatrogenic immunodeficiency lymphomas other than PTLD.

Design outcomes

Primary

MeasureTime frame
Detection of ctDNA at diagnosis and response evaluation

Secondary

MeasureTime frame
- Sensitivity and specificity of plasma ctDNA genotyping in comparison with tumor sample DNA (gDNA) as gold standard - Changes in ctDNA abundance throughout therapy - Clinical end-points: progression free survival (PFS), overall survival (OS), event free survival (EFS), disease specific survival (DSS)

Contacts

Public ContactFilipe Jesus
f.m.montes.de.jesus@umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)