Clinical trial · Observational
Evaluating Myelodysplastic Syndrome Risks in NET Patients Planned for Peptide Radionuclide Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood collection | Diagnostic Test | — | UNRESOLVED |
| Peptide receptor radionuclide therapy (PRRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Previous PRRT
- description
- Patients who have received PRRT within the last 4 years. There are no baseline levels available for cohort A patients. Sample size: 20.
- interventionNames
- Diagnostic Test: Blood collection
- label
- Planned for PRRT
- description
- Patients who are scheduled to start PRRT in the next 3 months. Pre-PRRT clonal expansion status will only be available form this cohort. These patients will provide a comprehensive record of development of CH from exposure to PRRT. Sample size: 20.
- interventionNames
- Radiation: Peptide receptor radionuclide therapy (PRRT)
- Diagnostic Test: Blood collection
- label
- Post PRRT Diagnosed with t-MN (MDS or AML)
- description
- Patients who have t-MN (MDS or AML). Sample size: 5.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria:
* ECOG 0-3
* Life expectancy \> 6 months
* Informed consent and willingness to undergoing serial genetic panel CHIP testing.
* Cohort Specific criteria
1. Cohort A: PRRT completed within 5 years of enrolment
2. Cohort B: PRRT planned to commence within 4 months of enrolment
3. Cohort C: diagnosis of MDS or AML following prior PRRT.
Exclusion Criteria:
* Unwillingness to provide blood sample and follow up as per protocolReferences
Publications (0)
Data not yet available