Invasive Breast CancerNCT06357338
Differential Expression and Potential Value of c-MYC in Non-Invasive and Invasive Mammary Carcinoma
An observational study of Invasive Breast Cancer, run by Marwa Mahmoud Hassan at 1 site in Egypt.
Trial summary
Retrospective observational study to evaluate c-MYC expression in non invasive and invasive mammry carcinoma Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Invasive Breast Cancer
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Mar 2024to 1 Apr 2026
- 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 15 years and older
- Women only
- Child, Adult, Older adult
Study population: women with breast lumps administered to oncology center
Who may be able to join
- Specimens of Modified Radical Mastectomies from breast carcinoma patients
Who cannot join
- Cases with insufficient clinical data.
- Tissue blocks of destroyed or insufficient material, unfit for diagnosis.
- Cases who received pre-operative chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Expression and Potential Value of c-MYC in Non-invasive and Invasive Mammary Carcinoma
Retrospective observational study to evaluate c-MYC expression in non invasive and invasive mammry carcinoma
Read the detailed description
To correlate different levels of c-MYC expressions with variable clinical and pathological parameters of mammary carcinoma (such as patients' ages, tumor grading, staging, laterality, focality and nodal metastasis, co-existing in-situ components). This study will be carried out on archived formalin-fixed and paraffin embedded tissue blocks that were belonged to 70 women with breast lumps.
- Conditions
- Invasive Breast Cancer
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| non invasive mammary carcinoma | 35 cases with non invasive breast cancer with low and high nuclear grades and co existing microfoci of invasion Receives: Other: no intervention | |
| invasive mammary carcinoma | 35 cases of invasive breast cancer undergone MRM and classify them according grading, staging and luminal subtypes Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
role of c-MYC in breast cancer
difference between expression of c-MYC in non invasive and invasive mammary carcinoma
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start19 Mar 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marwa Mahmoud Hassan
- Sponsor type
- University, hospital or other
- Collaborators
- Qena Oncology Center
- Responsible party
- Sponsor-investigator, Marwa Mahmoud Hassan, Sohag University
- Investigators
- Afaf Alnashar, professor, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357338
- Sponsor's protocol ID
- Soh-Med-24-03-15MS
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gao FY, Li XT, Xu K, Wang RT, Guan XX. c-MYC mediates the crosstalk between breast cancer cells and tumor microenvironment. Cell Commun Signal. 2023 Jan 31;21(1):28. doi: 10.1186/s12964-023-01043-1.
PubMed 36721232
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Expression and Potential Value of c-MYC in Non-invasive and Invasive Mammary Carcinoma
- ClinicalTrials.gov ID
- NCT06357338
- Acronym / sponsor ID
- Soh-Med-24-03-15MS
- Conditions
- Invasive Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marwa Mahmoud HassanUniversity, hospital or other
- Collaborators
- Qena Oncology Center
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 10 Apr 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.
Retrospective observational study to evaluate c-MYC expression in non invasive and invasive mammry carcinoma
Detailed description
To correlate different levels of c-MYC expressions with variable clinical and pathological parameters of mammary carcinoma (such as patients' ages, tumor grading, staging, laterality, focality and nodal metastasis, co-existing in-situ components). This study will be carried out on archived formalin-fixed and paraffin embedded tissue blocks that were belonged to 70 women with breast lumps.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non invasive mammary carcinoma | – | Other: no intervention35 cases with non invasive breast cancer with low and high nuclear grades and co existing microfoci of invasion |
| invasive mammary carcinoma | – | Other: no intervention35 cases of invasive breast cancer undergone MRM and classify them according grading, staging and luminal subtypes |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- women with breast lumps administered to oncology center
Key inclusion criteria (1 listed)
- Specimens of Modified Radical Mastectomies from breast carcinoma patients
Key exclusion criteria (3 listed)
- Cases with insufficient clinical data.
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 |
|---|---|---|
| no interventionNo intervention | Other | invasive mammary carcinoma, non invasive mammary carcinoma |
Primary outcome
role of c-MYC in breast cancer
Time frame: 1 year
difference between expression of c-MYC in non invasive and invasive mammary carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 36721232Gao FY, Li XT, Xu K, Wang RT, Guan XX. c-MYC mediates the crosstalk between breast cancer cells and tumor microenvironment. Cell Commun Signal. 2023 Jan 31;21(1):28. doi: 10.1186/s12964-023-01043-1.
- Individual participant dataSharing planned: Undecided
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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.
Afaf Alnashar, professor principal investigator
Sohag University
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 Invasive Breast Cancer, run by Marwa Mahmoud Hassan 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 1 inclusion and 3 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 10 Apr 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
role of c-MYC in breast cancer (time frame: 1 year). 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 NCT06357338, which also lists 1 linked publication.
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 10 Apr 2024.