Breast Cancer FemaleNCT05699577
Prognostic Value of Some Biochemical Markers in Breast Cancer
An observational study of Breast Cancer Female, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- serum sample for ELIZA
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: female patients with breast cancer
Who may be able to join
- 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
Who cannot join
- female patients less than 18 years patients having comorbid disease. patients with double malignancy
Trial locations and contacts
1 site in 1 country.
muhammed a abd el moety, professor contact
About this study
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.
- Conditions
- Breast Cancer Female
- Being tested
- serum sample for ELIZA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum sample for ELIZADiagnostic test
ELIZA for Ca15-3 and interferon gamma
| Study group | Role | What they receive |
|---|---|---|
| metastatic breast cancer | Not described Receives: Diagnostic Test: serum sample for ELIZA | |
| non metastatic breast cancer | Not described Receives: Diagnostic Test: serum sample for ELIZA |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum level of Ca15-3
Tumer marker
Measured: 6 months
serum level of interferon gamma
Tumer marker
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Fathy Abdelrasoul, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699577
- Sponsor's protocol ID
- Soh-Med-23-01-07
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 33538338Uygur 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.
PubMed 34082362Jorgovanovic 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.
PubMed 33005420Mendoza 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.
PubMed 30814731
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Some Biochemical Markers in Breast Cancer
- ClinicalTrials.gov ID
- NCT05699577
- Acronym / sponsor ID
- Soh-Med-23-01-07
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metastatic breast cancer | – | Diagnostic Test: serum sample for ELIZA |
| non metastatic breast cancer | – | Diagnostic Test: serum sample for ELIZA |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- female patients with breast cancer
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- female patients less than 18 years patients having comorbid disease. patients with double malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum sample for ELIZAELIZA for Ca15-3 and interferon gamma | Diagnostic test | metastatic breast cancer, non metastatic breast cancer |
Primary outcome
serum level of Ca15-3
Time frame: 6 months
Tumer marker
serum level of interferon gamma
Time frame: 6 months
Tumer marker
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 33538338Sung 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.
- Background: PubMed 34082362Uygur 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.
- Background: PubMed 33005420Jorgovanovic 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.
- Background: PubMed 30814731Mendoza 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
muhammed a abd el moety, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact amany f abd alrasol, demonstrator (01065211221, amanyfathy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum level of Ca15-3 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05699577, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.