NCT06196216

Brief Summary

The aims of this study are To evaluate the CT features of incidental breast lesions on chest CT and subsequently suggest useful criteria for referral to a specialized breast unit.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress63%
Dec 2023Oct 2027

Study Start

First participant enrolled

December 20, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

2.8 years

First QC Date

December 24, 2023

Last Update Submit

December 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • detect useful CT criteria of breast lesions subsequently suggest criteria for referral to a specialized breast unit

    detect useful CT criteria of breast lesions subsequently suggest criteria for referral to a specialized breast unit

    3years

Interventions

MSCTRADIATION

Enhanced CT chest

Eligibility Criteria

Age25 Years - 95 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult female
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult female patients who underwent enhanced CT chest that incidentally revealed breast lesion(s) then referred to a specialized breast centre and had histopathological diagnosis.

You may not qualify if:

  • Patients with known breast dis ease.
  • Previous history of breast cancer or breast surgery.
  • Patients who had undergone only non-enhanced CT examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (2)

  • Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.

    PMID: 25328522BACKGROUND
  • Harish MG, Konda SD, MacMahon H, Newstead GM. Breast lesions incidentally detected with CT: what the general radiologist needs to know. Radiographics. 2007 Oct;27 Suppl 1:S37-51. doi: 10.1148/rg.27si075510.

    PMID: 18180233BACKGROUND

Study Officials

  • Abo-Elhassan Hassib Mohamed, Associate professor

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 24, 2023

First Posted

January 9, 2024

Study Start

December 20, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

January 9, 2024

Record last verified: 2023-12

Locations