RecruitingACTRN12618000362291

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.


Sponsor

Dr Andrew Parker

Enrollment

20 participants

Start Date

Nov 9, 2017

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing two new blood testing methods — flow cytometry and immunohistochemistry — to detect a genetic mutation called the Calreticulin (CALR) mutation, which is found in certain blood disorders called myeloproliferative disorders. Currently, this mutation is detected by a technique that takes more time and resources. If these new methods are accurate, testing for CALR mutations could become faster, cheaper, and less invasive. Participants simply provide an extra 10 mL of blood during their routine blood tests. You may be eligible if: - You are 18 years or older - You have a known myeloproliferative disorder - You have previously had molecular testing for JAK2, MPL, or CALR mutations - You are an active patient of the St Vincent's Hospital Haematology Service with regular blood tests You may NOT be eligible if: - You have a psychological illness or condition that would prevent you from understanding the study or giving consent Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 cl

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.


Locations(1)

St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

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ACTRN12618000362291


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