Pre-myeloid Cancer and Bone Marrow Failure Clinic Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02958462|
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myeloid Malignancy Inherited Bone Marrow Failure Syndrome Clonal Expansion Cytopenia||Other: follow up||Not Applicable|
The pre-myeloid cancer and bone marrow failure clinic is an individualized medicine clinic conceptualized for the early detection of myeloid malignancies such as, myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), MDS/MPN overlap syndromes and acute myeloid leukemia (AML). Using next-generation sequencing technologies, clonal hematopoietic stem cell changes can be detected early on in myeloid malignancies. These changes are currently classified as follows:
- Idiopathic cytopenias of unclear significance (ICUS).
- Clonal cytopenias of unclear significance (CCUS).
- Clonal hematopoiesis of indeterminate prognosis (CHIP).
- Bone marrow failure syndromes with risk for clonal myeloid transformation.
- Familial/Germline syndromes with increased risk for myeloid malignancies.
This clinic blends next-generation sequencing technologies with functional studies to help identify, prognosticate and define management plans; including early intervention strategies, for affected patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pre-myeloid Cancer and Bone Marrow Failure Clinic Study|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||January 2023|
Potential Premyeloid Cancer or Bone Marrow Failure Patients
Follow up provided for patients tested using Next Generation Sequencing (NGS) and other relevant functional studies
Other: follow up
- Number of subjects whose cytopenias are persistent or progressive over the course of the 5 year study [ Time Frame: Through study completion, an average of 5 years ]
- Number of subjects who have evolved to myelodspalstic syndrome (MDS) or acute myeloid leukemia (aml) over the course of the five year study [ Time Frame: Through study completion, an average of 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958462
|Contact: Gillian Currie, BScemail@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Mrinal S Patnaik, MBBS||Mayo Clinic|