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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48552

Enrollment

Registered

2018-10-22

Start date

2019-04-12

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

post-transplant lymphoma PTLD

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients having undergone a solid organ transplantation or hematopoietic stem cell transplantation. - 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 -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. -Known to be HIV positive.

Design outcomes

Primary

Measure	Time frame
1 - Detection of ctDNA at diagnosis and response evaluation	—

Secondary

Measure	Time frame
2 - Sensitivity and specificity of plasma ctDNA genotyping in comparison with tumor sample DNA (gDNA) as gold standard 3 - Changes in ctDNA abundance throughout therapy 4 - Clinical end-points: progression free survival (PFS), overall survival (OS), event free survival (EFS), disease specific survival (DSS)	—

Countries

Netherlands

Outcome results