Laboratory Studies Into the Pathology of Leukaemia | NCT03233763

Studies
Laboratory Studies Into the Pathology of Leukaemia

NCT03233763

Sponsor

Royal Marsden NHS Foundation Trust

Status

Unknown status

Last Update Posted

Jul 31, 2017Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Leukemia

Interventions

Bone Marrow Aspirate

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2017Actual

Primary Completion Date

Feb 1, 2021Estimated

Completion Date

Feb 1, 2021Estimated

First Submitted Date

Jan 18, 2017

First Submission Date that Met QC Criteria

Jul 26, 2017

First Posted Date

Jul 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2017

Last Update Posted Date

Jul 31, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ongoing laboratory work into the pathology of Leukaemia:

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bone Marrow Aspirate	Procedure	Diagnostic Bone Marrow aspirate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pathology of Leukaemia cells	Pathology of Leukaemia cells	15 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 & Over Diagnosis of AML Generic Research consent given

Exclusion Criteria:

Under 18 No generic research consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leonora Conneely	Contact	0208 661 3018		leonora.conneely@rmh.nhs.uk

Overall Officials

Name	Affiliation	Role
David Taussig	Royal Marsden NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Haematology, the Royal Marsden NHS Foundation Trust	Recruiting	Sutton	Surrey	SM2 5PT	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Access to patient tissue is via formal request to the Sponsor

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided