Breast CancerNCT06592560
Asprosin in Breast Cancer
An observational study of Breast Cancer, run by Marina Hanna Thabet Ghobrial.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ELISA
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2025
- 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
- All sexes
- No healthy volunteers
- Adult
Study population: Group 1: healthy controls from healthy volunteers. Group 2: patients with benign breast lesions. Group 3: breast cancer patients
Who may be able to join
- -
- 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.
Who cannot join
- 1- Female patients with any other type of malignant or benign tumors. 2- Past history of chemotherapy or surgical treatment of cancer.
Trial locations and contacts
No sites are listed yet.
Eman Mohamed Abdelrahman contact
About this study
Official title: Diagnostic Value of Asprosin As a Biomarker in Breast Cancer
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
- Conditions
- Breast Cancer
- Being tested
- ELISA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISADevice
Specific test: Assay of asprosin marker will be measured by enzyme-linked immunosorbent assay ( ELISA).
| Study group | Role | What they receive |
|---|---|---|
| Healthy people | Not described Receives: Device: ELISA | |
| Patients with benign breast lesions | Not described Receives: Device: ELISA | |
| Patients with breast cancer | Not described Receives: Device: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (1)
Diagnostic value of Asprosin as a biomarker in breast cancer
Comparing asproin and the routine markers (CEA, CA15-3) as biomarkers for diagnosis of breast cancer.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marina Hanna Thabet Ghobrial
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marina Hanna Thabet Ghobrial, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592560
- Sponsor's protocol ID
- Asprosin
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Asprosin As a Biomarker in Breast Cancer
- ClinicalTrials.gov ID
- NCT06592560
- Acronym / sponsor ID
- Asprosin
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Marina Hanna Thabet GhobrialUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy people | – | Device: ELISA |
| Patients with benign breast lesions | – | Device: ELISA |
| Patients with breast cancer | – | Device: ELISA |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Group 1: healthy controls from healthy volunteers. Group 2: patients with benign breast lesions. Group 3: breast cancer patients
Key inclusion criteria (3 listed)
- -
- 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.
Key exclusion criteria (1 listed)
- 1- Female patients with any other type of malignant or benign tumors. 2- Past history of chemotherapy or surgical treatment of cancer.
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 |
|---|---|---|
| ELISASpecific test: Assay of asprosin marker will be measured by enzyme-linked immunosorbent assay ( ELISA). | Device | Healthy people, Patients with benign breast lesions, Patients with breast cancer |
Primary outcome
Diagnostic value of Asprosin as a biomarker in breast cancer
Time frame: Baseline
Evaluation of the clinical utility of measurement of asprosin as a non invasive biomarker in the diagnosis of breast cancer
1 secondary outcome
Diagnostic value of Asprosin as a biomarker in breast cancer
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Eman Mohamed Abdelrahman contact
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Marina Hanna Thabet Ghobrial.
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 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Marina Hanna Thabet (01007970949, hannamarina626@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value of Asprosin as a biomarker in breast cancer (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.