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Determination of Calreticulin (CALR) mutation status based on peripheral blood immunohistochemistry and flow cytometry.

Determination of CALR mutation status based on peripheral blood immunohistochemistry and flow cytometry in patients with myeloproliferative neoplasms.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000362291
Enrollment
1
Registered
2018-03-09
Start date
2017-11-09
Completion date
2018-12-31
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine if new blood testing methods are effective in determining Calreticulin mutation status. Who is it for? You may be eligible for this study if you are over the age of 18, have a known myeloproliferative disorder and are currently undergoing regular blood tests at St Vincent’s Hospital. Study details Participants will continue to undergo regular testing by clinicians. However, an additional 10mL of blood will be collected during your routine venesection. This sample will then be tested for Calreticulin mutation using both of the following tests: 1. Flow cytometry 2. Immunohistochemistry The results will then be compared to results from the current gold standard method used for testing for Calreticulin mutations. It is hoped that results from this study would allow testing for Calreticulin mutation to be done rapidly, locally and non-invasively.

Interventions

The two new methods being investigated are: 1) Flow cytometry using a fluorochrome conjugated to a CALR antibody on peripheral blood 2) Immunohistochemistry using a CALR immunostain on peripheral clotted blood. An extra 10mL volume of blood will be collected during routine venesection undertaken as part of routine care with the participant's treating haematologist. This sample will then be split with part used for flow cytometric analysis and the remainder for immunohistochemistry. This will

The two new methods being investigated are: 1) Flow cytometry using a fluorochrome conjugated to a CALR antibody on peripheral blood 2) Immunohistochemistry using a CALR immunostain on peripheral clotted blood. An extra 10mL volume of blood will be collected during routine venesection undertaken as part of routine care with the participant's treating haematologist. This sample will then be split with part used for flow cytometric analysis and the remainder for immunohistochemistry. This will only be performed a single time on a single blood sample, and there will be no followup testing or review required of the participant.

Sponsors

Dr Andrew Parker
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Known Myeloproliferative Disorder Molecular Testing for JAK2 or MPL or CALR mutation previously performed Cases: CALR positive Controls: CALR negative OR JAK2 positive OR MPL positive Undergoing regular blood tests as a patient of St Vincent’s Hospital Haematology Service Willingness to provide written consent and participate in the study.

Exclusion criteria

Patients with a history of a psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study or to consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026