NCT06169007

Brief Summary

Checkpoint proteins regulate the immune system; breast cancer cells exploit the up-regulation or down-regulation of these proteins to evade anti-tumour immune responses . It is now well recognized that advanced metastatic BC and early disease are associated with both localized and systemic immune dysfunction .in this study levels of soluble immune checkpoint molecules sTIM3 and sCD40 will be measured and compared with tissue form ,then follow up to patients' prognosis and the relation to markers levels.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Status
unknown

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

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

December 5, 2023

Last Update Submit

December 14, 2023

Conditions

Keywords

breast cancer and sCD40 and sTIM-3

Outcome Measures

Primary Outcomes (1)

  • evaluate the levels of sTIM-3 and sCD40 in breast cancer patients in different stages and follow up their role in disease prognosis compared with healthy controls. Results will be compared with the previous studies.

    study will take about 12months to be completed

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients with breast cancer and healthy females as controls

You may qualify if:

  • Female patients with breast cancer aged \> 18 years attending the Medical Oncology department of South Egypt Cancer Institute

You may not qualify if:

  • Patients on chemotherapy
  • A history of any other malignancy
  • known (HIV) and/or hepatitis B or hepatitis C viruses,
  • pregnancy or breast feeding
  • patients or controls that refuse to be a part of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lamiaa Fadel, lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Asmaa Mohammed, demostrator

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 13, 2023

Study Start

May 1, 2024

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

December 20, 2023

Record last verified: 2023-12