Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510868
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Evaluating Myelodysplastic Syndrome Risks in NET Patients Planned for Peptide Radionuclide Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating Myelodysplastic Syndrome Risks in NET Patients Planned for Peptide Radionuclide Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MDS PRRT
Brief 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
Detailed Description:
Radiopharmaceuticals is currently used for the treatment of metastatic cancer date While radiopharmaceuticals are generally well tolerated one of its most devastating long-term toxicities is the development of therapy related myeloid neoplasms t-MN an umbrella term for myelodysplastic syndrome MDS and acute myeloid leukemia AML PRRT Receptor Radionuclide Therapy is a targeted radiopharmaceutical therapy RPT used to treat neuroendocrine tumors RPTs use drugs to attack cancer cells while reducing harm to healthy tissue PRRT delivers high doses of radiation to tumors in the body to destroy or slow their growth and reduce disease side effects
While PRRT is generally well tolerated one of its long-term side effects is the development of therapy related myelodysplastic syndrome MDS and acute myeloid leukemia AML The identification of genetic changes that lead to the development of MDS and AML during PRRT is a growing area of research It is now known that the genetic changes that lead to progression into AML typically occur through many years of pre-leukemic hematopoietic stem cell clonal evolution before development of late mutations that lead to malignant disease The short interval between exposure to PRRT and appearance of MDS and AML would suggest some patients are already at high risk of developing AML and are potentially detectable The ability to identify individuals predisposed to developing MDSAML could improve patient selection for PRRT and design strategies to mitigate the development of MDSAML
This research proposes to study the genetic changes that occur pre-PRRT and post-PRRT using blood samples obtained from a patient population at Princess Margaret Hospital Cohort A will consist of 20 patients that have had PRRT within the past 4 years Cohort B will consist of 20 patients planned for PRRT Cohort C will consist of 1-5 patients post PRRT diagnosed with t-MN
While PRRT is generally well tolerated one of its long-term side effects is the development of therapy related myelodysplastic syndrome MDS and acute myeloid leukemia AML The identification of genetic changes that lead to the development of MDS and AML during PRRT is a growing area of research It is now known that the genetic changes that lead to progression into AML typically occur through many years of pre-leukemic hematopoietic stem cell clonal evolution before development of late mutations that lead to malignant disease The short interval between exposure to PRRT and appearance of MDS and AML would suggest some patients are already at high risk of developing AML and are potentially detectable The ability to identify individuals predisposed to developing MDSAML could improve patient selection for PRRT and design strategies to mitigate the development of MDSAML
This research proposes to study the genetic changes that occur pre-PRRT and post-PRRT using blood samples obtained from a patient population at Princess Margaret Hospital Cohort A will consist of 20 patients that have had PRRT within the past 4 years Cohort B will consist of 20 patients planned for PRRT Cohort C will consist of 1-5 patients post PRRT diagnosed with t-MN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None