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RP% Measurement by FCM as a Diagnostic Test for ITP

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ClinicalTrials.gov Identifier: NCT02967328
Recruitment Status : Unknown
Verified November 2016 by Ming Hou, Shandong University.
Recruitment status was:  Recruiting
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
Sponsor:
Collaborators:
Jinan Central Hospital
Shandong Qianfoshan Hospital
Information provided by (Responsible Party):
Ming Hou, Shandong University

Tracking Information
First Submitted Date November 16, 2016
First Posted Date November 18, 2016
Last Update Posted Date November 18, 2016
Study Start Date November 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 17, 2016)
Total platelet count (RP%) [ Time Frame: The day upon enrollment ]
We defined an upper limit for healthy control subjects as mean + 3SD in this study.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title RP% Measurement by FCM as a Diagnostic Test for ITP
Official Title A Multi-Center Prospective Blind Study of RP% Measurement by Flow Cytometry in the Diagnosis of Primary Immune Thrombocytopenia
Brief Summary Immature platelets-also termed reticulated platelets (RP)-are platelets newly released into the circulation, and have been associated with a variety of pathological bleeding events including primary immune thrombocytopenia (ITP). They can be assessed by flow cytometry (FCM) after staining with thiazole orange (TO) at low concentration and expressed as a fraction of the total platelet count (RP%). The diagnosis of primary ITP is based on differential diagnosis and the measurement of RP% can serve as an alternative diagnostic test that are useful in daily practice. Our study aimed at distinguishing primary ITP from other thrombocytopenic disorders, especially aplstic (hypoplastic) or chemotherapy-induced thrombocytopenia by FCM. The sensitivity and specificity of the assay as well as agreement between RP% measurement and monoclonal antibody-specific immobilization of platelet antigen (MAIPA) were analyzed accordingly.
Detailed Description

The investigators are undertaking a multi-center, prospective blind trial of 500 adults with thrombocytopenic disorders with a platelet count less than 60*10^9/L from 4 medical centers in China. In brief, 15 μl aliquots of anti-coagulated whole blood were incubated for 70 min with 5 μl of phycoerythrin-conjugated anti-CD42b monoclonal antibody (BD Pharmingen, Tokyo, Japan) and 1 ml of thiazole orange (Retic-COUNT; Becton-Dickinson, San Jose, CA, USA) diluted 10 times by phosphate-buffered saline. RP% was analyzed on a flow cytometer (FACScan, Becton-Dickinson) by measuring 10,000 events in the CD42b-positive fraction.

Clinical information of all participants including gender, age, platelet count and definitive diagnosis were recorded by an exclusive investigator. RP% results were revealed at the end of recruitment and after all FCM measurements were completed. The agreement between clinical diagnosis and RP% results were analyzed to identify primary ITP.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 500 adults with thrombocytopenic disorders with a platelet count less than 60000/uL from 4 medical centers in China.
Condition Immune Thrombocytopenia
Intervention Other: RP% Measurement by FCM as a Diagnostic Test for ITP
Study Groups/Cohorts RP% Measurement by FCM as a Diagnostic Test for ITP
The investigators are undertaking a multi-center, prospective blind trial of 500 adults with thrombocytopenic disorders with a platelet count less than 60000/uL from 4 medical centers in China. In brief, 15 ul aliquots of anti-coagulated whole blood were incubated for 70 min with 5 ul of phycoerythrin-conjugated anti-CD42b monoclonal antibody (BD Pharmingen, Tokyo, Japan) and 1 ml of thiazole orange (Retic-COUNT; Becton-Dickinson, San Jose, CA, USA) diluted 10 times by phosphate-buffered saline. RP% was analyzed on a flow cytometer (FACScan, Becton-Dickinson) by measuring 10,000 events in the CD42b-positive fraction.
Intervention: Other: RP% Measurement by FCM as a Diagnostic Test for ITP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 17, 2016)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Untreated adult patients of both gender between the ages of 18 and 75 years
  2. Each participant showed a platelet count 60*10^9/L, with or without bleeding manifestations
  3. Thrombocytopenic disorders including autoimmune-mediated, aplastic (hypoplastic) or chemotherapy-induced thrombocytopenia

Exclusion Criteria:

  1. Received high-dose steroids or IVIG within 3 weeks prior to the test
  2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months prior to the test
  3. Current HIV infection, hepatitis B virus or hepatitis C virus infections
  4. Severe medical condition (liver and kidney function impairment). Unstable cardiovascular disease or uncontrolled hypertension.
  5. Patients who are deemed unsuitable for the study by the investigator
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02967328
Other Study ID Numbers ITP-Reticulated Platelets
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ming Hou, Shandong University
Study Sponsor Shandong University
Collaborators
  • Jinan Central Hospital
  • Shandong Qianfoshan Hospital
Investigators Not Provided
PRS Account Shandong University
Verification Date November 2016