NCT05699577

Brief Summary

breast cancer is the most common type of cancer in women and first cause of cancer death among them. in Egypt it constitutes 33% of female cancer cases and more than22000 new cases diagnosed each year. there are many prognostic factors for breast cancer as Tumer size, axillary lymph node status, hormonal receptor status, and tumer markers as Ca15-3 and interferon gamma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

January 17, 2023

Last Update Submit

January 17, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • serum level of Ca15-3

    Tumer marker

    6 months

  • serum level of interferon gamma

    Tumer marker

    6 months

Study Arms (2)

metastatic breast cancer

Diagnostic Test: serum sample for ELIZA

non metastatic breast cancer

Diagnostic Test: serum sample for ELIZA

Interventions

serum sample for ELIZADIAGNOSTIC_TEST

ELIZA for Ca15-3 and interferon gamma

metastatic breast cancernon metastatic breast cancer

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

female patients with breast cancer

You may qualify if:

  • female patients aged more than or equal 18 year diagnosed with breast cancer
  • metastatic and non-metastatic cancer premenopausal and postmenopausal female positive and negative hormonal receptors and HER2 receptor taking any systemic treatment taking radiotherapy or not

You may not qualify if:

  • female patients less than 18 years patients having comorbid disease. patients with double malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PMID: 33538338BACKGROUND
  • Uygur MM, Gumus M. The utility of serum tumor markers CEA and CA 15-3 for breast cancer prognosis and their association with clinicopathological parameters. Cancer Treat Res Commun. 2021;28:100402. doi: 10.1016/j.ctarc.2021.100402. Epub 2021 May 24.

    PMID: 34082362BACKGROUND
  • Jorgovanovic D, Song M, Wang L, Zhang Y. Roles of IFN-gamma in tumor progression and regression: a review. Biomark Res. 2020 Sep 29;8:49. doi: 10.1186/s40364-020-00228-x. eCollection 2020.

    PMID: 33005420BACKGROUND
  • Mendoza JL, Escalante NK, Jude KM, Sotolongo Bellon J, Su L, Horton TM, Tsutsumi N, Berardinelli SJ, Haltiwanger RS, Piehler J, Engleman EG, Garcia KC. Structure of the IFNgamma receptor complex guides design of biased agonists. Nature. 2019 Mar;567(7746):56-60. doi: 10.1038/s41586-019-0988-7. Epub 2019 Feb 27.

    PMID: 30814731BACKGROUND

Central Study Contacts

amany f abd alrasol, demonstrator

CONTACT

muhammed a abd el moety, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonestrator at medical biochemistry

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

February 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Locations