NCT06095752

Brief Summary

The aim of this study was to evaluate the impact of albumin / fibrinogen ratio, blood viscosity and RDW on the prognosis of a newly diagnosed MM patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

October 2, 2025

Status Verified

April 1, 2025

Enrollment Period

2.1 years

First QC Date

September 27, 2023

Last Update Submit

September 29, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year.

    After initial diagnosis of a patient to have multiple myeloma , blood viscosity is obtained and within a year , a relation is established between the prognosis of the disease and the initial results of blood viscosity

    One year

  • Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year.

    After initial diagnosis of a patient to have multiple myeloma , albumin / fibrinogen ratio is obtained and within a year , a relation is established between the prognosis of the disease and the initial results of albumin /fibrinogen ratio

    One year

  • Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year.

    After initial diagnosis of a patient to have multiple myeloma , red cell distribution is obtained and within a year , a relation is established between the prognosis of the disease and the initial results of red cell distribution

    One year

Interventions

In multiple myeloma patients ,we get blood viscosity , albumin / fibrinogen ratio and red cell distribution directly after confirmed diagnosis to determine the prognosis of the disease in association with these tests results

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

based on study methodology , the studied population (who are the newly diagnosed cases ) will be followed up to one year after diagnosis to report outcomes . the researcher will recruit the newly diagnosed cases who seek care at internal medicine department, assiut university hospital in completed one year duration and then follow up the case for one year. After reviewing medical record , average flow rate of MM at internal medicine department is 2 cases per month , nearly 25 cases will be included in this study

You may qualify if:

  • Patients newly diagnosed with MM according to International Myeloma Working Group criteria 2016.

You may not qualify if:

  • Patient previously diagnosed MM and started treatment or in post treatment follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 88, Egypt

Location

MeSH Terms

Conditions

Multiple MyelomaHematologic Diseases

Interventions

Blood ViscosityAlbumins

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

HemorheologyBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaHemodynamicsCardiovascular Physiological PhenomenaProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor, Ahmed Radwan abdelhakim

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 23, 2023

Study Start

April 1, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

October 2, 2025

Record last verified: 2025-04

Locations