- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03233763
Laboratory Studies Into the Pathology of Leukaemia
Study Overview
Detailed Description
The investigators will test AML samples sent to the diagnostic laboratory from participants with newly diagnosed or relapsed/refractory AML. Samples will be sent from district general hospitals and teaching hospitals.
Results will be returned to referring clinicians in the same way investigators currently return results for samples sent for standard tests. The service will be advertised through the Royal Marsden Website with visibility to both participants and HCPs). The investigators will also inform all the clinicians involved in the AML working party (Dr Taussig is a member of the AML working group).
In addition we are looking at diagnostic approaches to IDH 1 and 2 mutation identification.
An initial comparison of 50 samples by three analysis methods will be conducted.
IDH1 and IDH2 variant discovery will first be performed using an established standard in house SOP (SOP: SMD103) for CE-SSCA
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Leonora Conneely
- Phone Number: 0208 661 3018
- Email: leonora.conneely@rmh.nhs.uk
Study Locations
-
-
Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- Recruiting
- Department of Haematology, the Royal Marsden NHS Foundation Trust
-
Contact:
- Leonora Conneely
- Phone Number: 0208 661 3018
- Email: HaematoOncRn@rmh.nhs.uk
-
Principal Investigator:
- David Taussig, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
18 & Over Diagnosis of AML Generic Research consent given
Exclusion Criteria:
Under 18 No generic research consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathology of Leukaemia cells
Time Frame: 15 years
|
Pathology of Leukaemia cells
|
15 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Taussig, Royal Marsden NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR4508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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