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ChromoSeq for Myelodysplastic Syndrome
N/A
Recruiting
Led By Meagan A Jacoby, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age.
Not been previously treated with disease-modifying therapy (such as lenalidomide or hypomethylating agents).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 1 month after generation of chromoseq for all patients enrolled (estimated to be 25 months)
Awards & highlights
Study Summary
This trial is testing a new way to sequence the genome of patients with myelodysplastic syndrome to see if it's feasible to use in addition to standard genomic testing.
Who is the study for?
This trial is for adults with Myelodysplastic Syndrome (MDS) or suspected MDS at Washington University School of Medicine. Participants must be willing to complete surveys about ChromoSeq, have not had disease-modifying treatments, and can sign a consent form. Those who've only had supportive treatments like transfusions or growth factors are eligible.Check my eligibility
What is being tested?
The study tests the use of Whole Genome Sequencing (ChromoSeq) alongside standard genomic testing in patients with MDS. It aims to assess how feasible it is to add this new test into routine care by collecting data and physician feedback.See study design
What are the potential side effects?
Since ChromoSeq is a diagnostic procedure rather than a treatment, it does not have direct side effects like medications do. However, there may be indirect consequences such as anxiety from learning new genetic information.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I haven't taken any drugs like lenalidomide for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 1 month after generation of chromoseq for all patients enrolled (estimated to be 25 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 1 month after generation of chromoseq for all patients enrolled (estimated to be 25 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biological Assay
Rate of assay success on first attempt between ChromoSeq and conventional cytogenetics as measured by total number of copy number alterations identified
Rate of assay success on first attempt between ChromoSeq and conventional cytogenetics as measured by total number of recurrent structural variants identified
Secondary outcome measures
Stakeholder perceptions of ChromoSeq
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Patients: ChromSeqExperimental Treatment1 Intervention
ChromoSeq will be performed on bone marrow or peripheral blood DNA from consented patients in parallel with the standard of care cytogenetics, FISH, and the MyeloSeq gene panel obtained from that sample, in a CLIA licensed environment using CLIA-compliant ChromoSeq procedures.
Group II: Stakeholders (Treating Physicians)Active Control1 Intervention
Stakeholders (treating physicians) will complete surveys/questionnaires
Find a Location
Who is running the clinical trial?
American Society of HematologyOTHER
12 Previous Clinical Trials
20,930 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,936 Previous Clinical Trials
2,299,630 Total Patients Enrolled
Meagan A Jacoby, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am diagnosed with MDS or suspected to have MDS, and tests are planned.I haven't taken any drugs like lenalidomide for my condition.You receive medical care as an outpatient rather than staying in the hospital.You agree to answer questions about your thoughts and experiences with ChromoSeq during its implementation process. You don't need to provide written consent.I have received blood transfusions or specific treatments to help with blood cell counts.You have a doctor at Washington University School of Medicine who manages treatment for blood cancers.You understand the study and agree to sign a document saying you want to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Patients: ChromSeq
- Group 2: Stakeholders (Treating Physicians)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this study still open?
"Indeed, the information hosted on clinicaltrials.gov suggests that this medical research is currently recruiting participants. It was first posted on July 27th 2022 and has since been updated to reflect a need for 60 subjects across 1 site."
Answered by AI
How many individuals will be participating in this research trial?
"Affirmative. Data hosted on clinicaltrials.gov attests to the fact that this medical study, which was initially published on July 27th 2022, is actively recruiting patients. Approximately 60 participants need to be enrolled from a single centre."
Answered by AI
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