This Study Investigates the Impact of Single Nucleotide P... | NCT06595758

Studies
This Study Investigates the Impact of Single Nucleotide Polymorphisms in Genes Involved in the Pharmacokinetics and Toxicity of Doxorubicin (DOX) in Egyptian Female Patients with Breast Cancer. It Also Aims to Explore the Association of Pretreatment Neutrophil to Lymphocyte Ratio to PCR

NCT06595758

Sponsor

Menoufia University

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Egypt

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

Brief Title

This Study Investigates the Impact of Single Nucleotide Polymorphisms in Genes Involved in the Pharmacokinetics and Toxicity of Doxorubicin (DOX) in Egyptian Female Patients with Breast Cancer. It Also Aims to Explore the Association of Pretreatment Neutrophil to Lymphocyte Ratio to PCR

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Nov 1, 2022Actual

Completion Date

Nov 1, 2023Actual

First Submitted Date

Sep 3, 2024

First Submission Date that Met QC Criteria

Sep 11, 2024

First Posted Date

Sep 19, 2024Actual

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

Sep 11, 2024

Last Update Posted Date

Sep 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Naglaa Fathy Mohamed Ebaid, Assistant Lecturer of clinical pharmacy, Menoufia UniversityPrincipal Investigator

Lead Sponsor

Menoufia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to investigate the effect of single nucleotide polymorphisms (SNPs) of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients.

It also aims to explore the association of pretreatment neutrophil to lymphocyte ratio (NLR) with pathological complete response (pCR).

Detailed Description

Plasma concentrations of doxorubicin will be determined and venous blood samples will be obtained from each patient for SNP genotyping of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients [prospective study].

A complete blood count was carried out at baseline for patients receiving neoadjuvant chemotherapy. The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes [ retrospective study].

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

Retention

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Doxorubicin plasma concentrations	Plasma concentrations of doxorubicin will be determined using a suitable analytical method.	baseline
neutrophil to lymphocyte ratio	The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes.	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females aged ≥ 18 years
Performance status 0 or 1
No contraindication to chemotherapy
Adequate bone marrow
Adequate hepatic function
Adequate renal function

Exclusion Criteria:

Poorly controlled diabetes mellitus
Ischemic heart disease
Uncontrolled hypertension
Active infections
Baseline ejection fraction &lt; 50%
Performance status ≥ 2
Pregnancy Lactation, bilateral breast cancer, male patients, primary surgery, distant metastases, other malignancies, inflammations, hematological disorders, autoimmune diseases, and patients taking non-steroidal anti-inflammatory drugs (NSAIDs), steroidal and antibiotic therapy.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

female Egyptian patients with breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Menofia university		Shibīn al Kawm			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17559346	Background	Lal S, Wong ZW, Jada SR, Xiang X, Chen Shu X, Ang PC, Figg WD, Lee EJ, Chowbay B. Novel SLC22A16 polymorphisms and influence on doxorubicin pharmacokinetics in Asian breast cancer patients. Pharmacogenomics. 2007 Jun;8(6):567-75. doi: 10.2217/14622416.8.6.567.
3042244	Background	Speth PA, van Hoesel QG, Haanen C. Clinical pharmacokinetics of doxorubicin. Clin Pharmacokinet. 1988 Jul;15(1):15-31. doi: 10.2165/00003088-198815010-00002.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases