NCT06320392

Brief Summary

Being a mechanistic study, this work aims to figure out "the role of the cytoplasmic mRNA deadenylase CNOT7 expressed protein on NK cell resistance in metastatic BC". In other words, to explore, whether, "CNOT7 contributes to metastasis in Egyptian female metastatic BC patient's cohort, through NK cell resistance, or not."

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

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

July 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.8 years

First QC Date

February 23, 2024

Last Update Submit

July 30, 2024

Conditions

Metastatic Breast Cancer

Keywords

CNOT7Breast cancerMetastasisNatural killerLAIR-1

Outcome Measures

Primary Outcomes (3)

  • Cytoplasmic mRNA deadenylase CNOT7 protein expression level in metastatic/advanced localized and non-metastatic BC sera using ELISA.

    12 months

  • CNOT7 tissue expression level in BC tissue samples categorized as metastatic vs non-metastatic tumor alongside with adjacent non-tumor tissue margin using immunohistochemistry.

    18 months

  • LAIR-1 protein expression level in BC patients peripheral blood samples using ELISA.

    12 months

Study Arms (2)

metastatic

44 female BC patients, volunteered in the study, diagnosed with metastatic BC. Patients were enrolled randomly from the Clinical Oncology Department, Faculty of Medicine, Mansoura University Hospitals, Mansoura University, Mansoura, Egypt, after signing the IC.

non-metastatic

46 female BC patients, volunteered in the study, diagnosed with primary naive (non-metastatic) invasive BC . Patients were enrolled randomly from the Clinical Oncology Department, Faculty of Medicine, Mansoura University Hospitals, Mansoura University, Mansoura, Egypt, after signing the IC.

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale with breast cancer (metastatic or non-metastatic)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

90 Egyptian female BC patients, volunteered in the study, diagnosed with either primary naive (non-metastatic) invasive BC (46 patients) or metastatic BC (44 patients). Patients were enrolled randomly from the Clinical Oncology Department, Faculty of Medicine, Mansoura University Hospitals, Mansoura University, Mansoura, Egypt, after signing the IC.

You may qualify if:

  • Adults over 18 years old with breast carcinoma of no special type (NST) confirmed pathologically.

You may not qualify if:

  • breast cancer patients with blood disorders
  • breast cancer patients with any cancer other than BC
  • breast cancer patients with liver cirrhosis
  • breast cancer patients with uterine or urinary bladder diseases
  • breast cancer patients with incomplete data or incomplete histopathology diagnosis report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab

Cairo, 11566, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* blood samples Four milliliters of peripheral venus blood were withdrawn once from each patient, under strict sterile conditions, following standard safety procedures. Sera obtained after centrifugation were aliquoted into three clean Eppendorf tubes and stored at -80°C. * Parafin sections Tissue Samples The tumor was fixed in 10% neutral buffered formalin fixative for 24 hours at room temperature before being embedded in paraffin using a TissueTek VIP automated processor in accordance with the standard protocol used in the laboratory for breast tumor diagnosis and staging, Mansoura University Hospitals.

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nadia Hamdy, PhD

    Faculty of pharmacy Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of biochemistry and molecular biology

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 20, 2024

Study Start

July 1, 2021

Primary Completion

May 1, 2023

Study Completion

June 1, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

EG(1)