NCT06592560

Brief Summary

To evaluate the clinical utility of Asprosin measurement in breast cancer patients in comparison with healthy controls and patients with benign breast lesions. To compare between Asprosin and the routine markers (CEA, CA15-3) as biomarkers for breast cancer diagnosis

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 Oct 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 10, 2024

Last Update Submit

September 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic value of Asprosin as a biomarker in breast cancer

    Evaluation of the clinical utility of measurement of asprosin as a non invasive biomarker in the diagnosis of breast cancer

    Baseline

Secondary Outcomes (1)

  • Diagnostic value of Asprosin as a biomarker in breast cancer

    Baseline

Study Arms (3)

Healthy people

Device: ELISA

Patients with benign breast lesions

Device: ELISA

Patients with breast cancer

Device: ELISA

Interventions

ELISADEVICE

Specific test: Assay of asprosin marker will be measured by enzyme-linked immunosorbent assay ( ELISA).

Healthy peoplePatients with benign breast lesionsPatients with breast cancer

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Group 1: healthy controls from healthy volunteers. Group 2: patients with benign breast lesions. Group 3: breast cancer patients

You may qualify if:

  • Females aged (40 ± 20 years) who did not receive any chemotherapy or surgical treatment and they will be divided as follow:
  • Group 1: healthy controls from healthy volunteers. Group 2: patients with benign breast lesions. Group 3: breast cancer patients.

You may not qualify if:

  • Female patients with any other type of malignant or benign tumors. 2- Past history of chemotherapy or surgical treatment of cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Enzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoenzyme TechniquesImmunoassayImmunologic TechniquesInvestigative TechniquesImmunosorbent TechniquesImmunohistochemistryMolecular Probe Techniques

Central Study Contacts

Marina Hanna Thabet

CONTACT

Eman Mohamed Abdelrahman

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share