RecruitingNCT06510868

Evaluating Myelodysplastic Syndrome Risks in NET Patients Planned for Peptide Radionuclide Therapy


Sponsor

University Health Network, Toronto

Enrollment

45 participants

Start Date

Aug 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is investigating whether patients with neuroendocrine tumors (NETs) who receive or have received a type of targeted radiation therapy called PRRT (peptide receptor radionuclide therapy) have an increased risk of developing a blood condition called myelodysplastic syndrome (MDS) — a disorder where the bone marrow doesn't produce healthy blood cells. Participants will have serial blood tests to monitor for early genetic changes. **You may be eligible if...** - You have a diagnosis of neuroendocrine tumors (NETs) - You are in good enough health (ECOG 0–3) with a life expectancy of more than 6 months - You fall into one of three groups: you completed PRRT within the past 5 years, you are about to start PRRT within 4 months, or you have been diagnosed with MDS or acute myeloid leukemia after prior PRRT - You are willing to provide blood samples and attend follow-up visits **You may NOT be eligible if...** - You are unwilling to provide blood samples or participate in follow-up as required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPeptide receptor radionuclide therapy (PRRT)

Specialized type of radionuclide therapy used to treat neuroendocrine tumors.

DIAGNOSTIC_TESTBlood collection

Patients will have approximately 5 ml of blood drawn 6,12,24,36,48, 60 months and at the time of MDS/AML diagnosis on follow up. Genomic DNA will be extracted from serum sample using the Qiagen QIAamp DNA Mini Kit. Single-molecule molecular inversion probes (smMIPs) will be used to detect mutations. Single nucleotide variants (SNVs), short insertions and deletions (indels), and mutated myeloid genes will be captured (e.g PPM1D, DNMT3A, TET2, TP53).


Locations(1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT06510868


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