Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837884
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-04-20
Brief Title:
Predicting Progression of Developing Myeloma in a High-Risk Screened Population
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
Predicting Progression of Developing Myeloma in a High-Risk Screened Population
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We will seek consent from participants to use the data and biospecimens collected according study protocol to address additional research questions for MGUS SMM MM and other conditions
Our overarching hypothesis is that early detection of MGUSSMM in a high- risk population along with the comprehensive characterization of genomicepigenomic and microenvironmentalimmune regulators of disease progression will lead to strategies that intercept disease progression and improve survival
Our overarching hypothesis is that early detection of MGUSSMM in a high- risk population along with the comprehensive characterization of genomicepigenomic and microenvironmentalimmune regulators of disease progression will lead to strategies that intercept disease progression and improve survival
Detailed Description:
Multiple Myeloma MM is a plasma cell dyscrasia characterized by bone marrow BM infiltration and lytic bone lesions Over 30 000 Americans are diagnosed annually with MM The estimated US prevalence is rising and this trend is likely to continue due to improvements in diagnosis and therapy Despite recent advances in therapy MM remains a fatal disease with a median survival of 5-10 years and most patients still succumb to disease progression Although many patients are diagnosed with earlier phases of disease most patients do not receive treatment until their disease progresses at which time they have overt end-organ damage This concept of initiating therapy at the time of symptomatic disease is analogous to initiating therapy in patients with solid tumors only after the development of measurable metastatic disease It is therefore not surprising that cure is not achieved for most patients with MM
Recent studies have shown that MM is consistently preceded by MGUS and SMM The incidence of MGUS is about 3 of the general population aged 50 years This was through the analysis of a cohort of 77000 people enrolled in a prospective population-based cancer screening trial that showed that multiple myeloma is consistently preceded by a precursor MGUS state MGUS progresses to over MM at a slow rate of 1 per year but in some patients the risk may be as high as 58 in 20 years SMM has an annual risk of progression of 10 The rate of progression of high-risk SMM is as high as 70 in 5 years
MGUS and SMM are often diagnosed incidentally when a physician orders a serum protein electrophoresis SPEP for a differential diagnosis of anemia bone pain or renal insufficiency Screening for early cancer detection has been implemented for many cancers including breast cancer with mammography and colon cancer with colonoscopy with variable success However a simple blood test for SPEP can accurately diagnose the presence of a plasma cell dyscrasia indicating that early detection can identify these precursor conditions In addition recent studies have demonstrated that early detection of MGUS can lead to improved overall survival compared to incidental diagnosis of overt myeloma presumably because these patients are followed more carefully and receive treatment before end-organ damage develops
Therefore high-risk populations include individuals with a first-degree relative that has been diagnosed with a plasma cell dyscrasia or other hematologic malignancy
Recent studies have shown that MM is consistently preceded by MGUS and SMM The incidence of MGUS is about 3 of the general population aged 50 years This was through the analysis of a cohort of 77000 people enrolled in a prospective population-based cancer screening trial that showed that multiple myeloma is consistently preceded by a precursor MGUS state MGUS progresses to over MM at a slow rate of 1 per year but in some patients the risk may be as high as 58 in 20 years SMM has an annual risk of progression of 10 The rate of progression of high-risk SMM is as high as 70 in 5 years
MGUS and SMM are often diagnosed incidentally when a physician orders a serum protein electrophoresis SPEP for a differential diagnosis of anemia bone pain or renal insufficiency Screening for early cancer detection has been implemented for many cancers including breast cancer with mammography and colon cancer with colonoscopy with variable success However a simple blood test for SPEP can accurately diagnose the presence of a plasma cell dyscrasia indicating that early detection can identify these precursor conditions In addition recent studies have demonstrated that early detection of MGUS can lead to improved overall survival compared to incidental diagnosis of overt myeloma presumably because these patients are followed more carefully and receive treatment before end-organ damage develops
Therefore high-risk populations include individuals with a first-degree relative that has been diagnosed with a plasma cell dyscrasia or other hematologic malignancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None