Laboratory Studies Into the Pathology of Leukaemia

Ongoing laboratory work into the pathology of Leukaemia:

Study Overview

• Status: Unknown
• Conditions: Leukemia
• Intervention / Treatment: Procedure: Bone Marrow Aspirate

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: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This is an exploratory laboratory study using stored tissue where consent has already been given.

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	Pathology of Leukaemia cells	15 years

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: David Taussig, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: CCR4508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Access to patient tissue is via formal request to the Sponsor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No