Survival Outcomes of Multiple Myeloma Patients Admitted o... | NCT05119205

Studies
Survival Outcomes of Multiple Myeloma Patients Admitted on Assiut Clinical Hematology Unit

NCT05119205

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Nov 22, 2021Actual

Enrollment

64Estimated

Phase

Not provided

Conditions

Multiple Myeloma Survival Outcome

Interventions

Bone marrow biopsy and compete blood count

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2022Estimated

Primary Completion Date

Jan 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Nov 2, 2021

First Submission Date that Met QC Criteria

Nov 2, 2021

First Posted Date

Nov 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2021

Last Update Posted Date

Nov 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our study will discuss survival outcomes of multiple myeloma patients admitted on Assiut clinical Hematology and role of neutrophil to lymphocyte and lymphocyte to monocyte ratios as prognostic factors in multiple myeloma.

Detailed Description

What are survival outcomes and the prognostic value of neutrophil to lymphocyte ratio of multiple myeloma patients admitted on Assiut clinical Hematology unit? Multiple myeloma (MM)is a plasma cell neoplasm associated with its characteristic clinical complications: anemia, infections, renal impairment or bone destruction. MM is the second most commonly diagnosed hematological neoplasm, with an incidence rate of 6.2 per 100 000 individuals .

Survival outcomes have remained constant over the past few decades; therefore, MM is still considered incurable. However, the increasing use of autologous stem cell transplantation (SCT) and the introduction of novel therapeutic agents, such as thalidomide and bortezomib, have improved the survival of myeloma patients .

Relationship between inflammation and cancer have been established. Some inflammatory factors from accessory cells in tumor milieu, such as interleukin-1 (IL-1), IL-6, and tumor necrosis factor-alpha (TNF-α), facilitated cancer cells' invasiveness .

Further studies exhibited the reactive oxygen and nitrogen from inflammatory cells induced mutation of some tumor suppressor genes, and inflammatory factors such as IL-6 and prostaglandin E2 (PGE2) caused DNA methylation, which both played an important role in tumorigenesis. Accordingly, neutrophil to lymphocyte ratio (NLR) coinciding with rationales supported by numerous studies, could offer a precise potency in predicting prognosis of cancers. In fact, many studies already demonstrated the prognostic significance of NLR in various cancers Consistently, a number of meta-analyses further confirmed this view in colorectal cancer, lung cancer, ovarian cancer, breast cancer, and lymphoma and others.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bone marrow biopsy and compete blood count	Diagnostic Test	Bone marrow biopsy and compete blood count will be done for follow up in patients with multiple myeloma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the survival outcomes of multiple myeloma patients admitted on Assiut clinical Hematology unit	Survival time will be measured as time from index date (that is, diagnosis date for MM patients) to the date of death; patients without a date of death were assumed alive at the end of the study period. Survival estimates will be assessed by types of treatment among MM patients. In addition, the proportion of patients who died or survived at least 2, 3 or 5 years after diagnosis will be also described.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: clinical and laboratory diagnosis of multiple myeloma

multiple myeloma patients received chemotherapy in our unit.

Exclusion Criteria:

Waldenstrom macroglobulinemia
MGUS
Amyloidosis
Other plasna cell disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with multiple myeloma in our unit will be included in the study and follow-up will be done to determine the outcome.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided