Evaluating Myelodysplastic Syndrome Risks in NET Patients Planned for Peptide Radionuclide Therapy
NCT Number: NCT06510868
Acronym: MDS & PRRT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myelodysplastic Syndrome|Acute Myeloid Leukemia
Interventions: RADIATION: Peptide receptor radionuclide therapy (PRRT)|DIAGNOSTIC_TEST: Blood collection
Sponsor: University Health Network, Toronto
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2029-06-30
Locations: Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9, Canada

Summary:
This is a prospective observational study which aims to identify individuals predisposed to developing myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) could improve patient outcomes in different ways. First, it will enable improved patient selection for PRRT where alternative treatment options are available. Second, understanding the final pathway and how it is modulated by PRRT could allow the design of strategies to halt this process. Third, while it is unknown whether the development of MDS and AML is a late effect of radiopharmaceuticals in general or it is confined to cancer populations or specific radioisotopes will need to be confirmed. Finally, understanding this devastating complication is expected to be the cornerstone towards advancing radiopharmaceuticals' role in the adjuvant setting.

Primary Outcome Measures: Identify individuals predisposed to developing MDS/AML to improve patient selection for PRRT where alternative treatment options are available., Determining the proportion of patients who screen positive for "prodromal AML genetic panel" pre PRRT., 5 years
Secondary Outcome Measures: Detection of Genetic Mutations in the Blood Post-PRRT, Enrolled patients will undergo serial genetic panel testing of blood samples annually for up to 5 years to detect genetic mutations., 5 years|Assessment of Variant Allele Frequencies Post-PRRT, Annual genetic panel testing will be conducted to determine variant allele frequencies in the blood of patients post-PRRT for up to 5 years. The frequencies of specific gene mutations (e.g., PPM1D, TET2, DNMT3A, TP53) will be measured and analyzed in relation to clinical characteristics and treatment history., 5 years|Incidence of Therapy-Related Myeloid Neoplasms (t-MN) Post-PRRT, The incidence of therapy-related myeloid neoplasms (MDS and AML) will be monitored in patients post-PRRT over a 5-year follow-up period. Data will include the time to t-MN development and any associated genetic mutations identified through annual blood genetic testing., 5 years|Proportion of Patients Developing MDS/AML Post-PRRT, Enrolled patients will undergo annual genetic panel testing for up to 5 years to determine the proportion who develop myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) after receiving PRRT. Data collected will include baseline clinical characteristics, the amount of PRRT received, prior antineoplastic therapies, and PRRT-related adverse events to help identify factors associated with the development of these conditions., 5 years|Identification of Clonal Mutations Conferring Increased Risk of MDS/AML Post-PRRT, Enrolled patients will undergo annual genetic panel testing for up to 5 years to identify clonal mutations associated with an increased risk of developing myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) after receiving PRRT., 5 years