Detection and Pathogenesis of Novel Protein F

From December 6, 2019 to March 23, 2020, the research group of Qingkun Fan found a novel protein(temporarily named protein F) in heparin anticoagulant plasma of three patients with heart disease. One patient was diagnosed with multiple myeloma.However, protein F cannot be detected by serum protein electrophoresis. Preliminary studies have shown that this novel protein F have an obvious absorption peak at about 600nm. Placed at 2-8 degrees for 7 days, protein F will be isolated from heparin plasma. To the naked eye, protein F appear to be transparent jelly between the red blood cells and the plasma. The specific protein F, how it is produced, how it causes disease are still unknown. This study will explore how to detect protein F and how it is produced.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma; Cardiac Disease

Detailed Description

Protein F screening was performed on anticoagulant blood plasma with heparin Lithium or blood serum by in-house turbidimetric method in Automatic biochemical analyzer.

All patients were followed-up for 3 years by telephones, routine appointment out-patient clinic or returning visit.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Qingkun Fan, MD; Phone Number: 027-65796747; Email: fqk@wahh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with heart diesease

Description

Inclusion Criteria:

• Testing total protein and albumin
• Testing routine blood test

Exclusion Criteria:

• high triglycerides (TG>5.00 mmol/L)
• hyperbilirubinemia (TBIL>170 mmol/L)
• fat emulsion used in past 3 days
• patients with hemolytic disease
• pregnant and lactating women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of plasma protein F content	the protein F content was measured by turbidimetric assay in automatic biochemical analyzer	six month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Multiple myeloma	Develop or be diagnosed with multiple myeloma	3 years

Collaborators and Investigators

• Sponsor: Wuhan Asia Heart Hospital
• Investigators: Study Chair: Zhenlu Zhang, MD，Ph,D, Wuhan Asia Heart Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2020
• Primary Completion (Anticipated): March 14, 2025
• Study Completion (Anticipated): March 14, 2028

Study Registration Dates

• First Submitted: April 4, 2020
• First Submitted That Met QC Criteria: April 4, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: diagnosis; multiple myeloma; protein; cardiac disease; globulin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Heart Diseases; Multiple Myeloma
• Other Study ID Numbers: YX-2020-B002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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