- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05699577
Prognostic Value of Some Biochemical Markers in Breast Cancer
January 17, 2023 updated by: Amany Fathy Abdelrasoul, Sohag University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: amany f abd alrasol, demonstrator
- Phone Number: 01065211221
- Email: amanyfathy@med.sohag.edu.eg
Study Contact Backup
- Name: muhammed a abd el moety, professor
Study Locations
-
-
-
Sohag, Egypt
- Sohag University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
female patients with breast cancer
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- female patients less than 18 years patients having comorbid disease. patients with double malignancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
metastatic breast cancer
|
ELIZA for Ca15-3 and interferon gamma
|
|
non metastatic breast cancer
|
ELIZA for Ca15-3 and interferon gamma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
serum level of Ca15-3
Time Frame: 6 months
|
Tumer marker
|
6 months
|
|
serum level of interferon gamma
Time Frame: 6 months
|
Tumer marker
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2023
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
January 17, 2023
First Submitted That Met QC Criteria
January 17, 2023
First Posted (Estimate)
January 26, 2023
Study Record Updates
Last Update Posted (Estimate)
January 26, 2023
Last Update Submitted That Met QC Criteria
January 17, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-23-01-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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