Invasive Breast CancerNCT05703815
EpCAM and p53 Expressions in Infiltrating Duct Carcinoma of the Breast
An observational study of Invasive Breast Cancer, run by Sohag University.
Trial summary
Breast cancer represents the most frequently diagnosed cancer in women. It represents the 5th leading cause of cancer mortality all over the world. In Egypt, breast cancer represents the 2nd most diagnosed cancer among all population. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Invasive Breast Cancer
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Mar 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: formalin-fixed and paraffin embedded tissue blocks from 40 patients with breast cancer
Who may be able to join
- Both incisional and excisional biopsy specimens. 2. All the studied cases include sufficient materials for the immunohistochemical study.
- 3. Complete clinical data.
Who cannot join
- Patients with recurrence of the primary tumor.
- Patients with a history of preoperative chemotherapy and/or radiotherapy.
- Insufficient or tiny tissue biopsies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: EpCAM and p53 Expressions in Infiltrating Duct Carcinoma of the Breast and Their Association With the Clinicopathological Prognostic Paremeters
Breast cancer represents the most frequently diagnosed cancer in women. It represents the 5th leading cause of cancer mortality all over the world.
In Egypt, breast cancer represents the 2nd most diagnosed cancer among all population. But among Egyptian females it represents the 1st diagnosed cancer representing 32.4%.
Read more
The main cause of death in breast cancer patients is tumor metastasis. Although only 5-10% of recently diagnosed breast cancer cases show metastasis to distant sites, but still there is a high risk for metastasis in patients with localized primary tumor following successful surgical management.
Epithelial cell adhesion molecule (EpCAM) is a cell adhesion molecule. It modifies cadherin mediated cell adhesion and it induces epithelial cell migration and proliferation. Some authors elucidate that EpCAM is involved in metastasis.
P53 is a known tumor suppressor gene involved in the control of cell cycle, DNA repair and apoptosis. It's one of the most mutated genes in cancer including breast cancer. Mutant p53 has a big role in tumor progression.
- Conditions
- Invasive Breast Cancer
- Keywords
- EpCAM, P53 , IDC
- Medical subject headings
- Colorectal Cancer, Hereditary Nonpolyposis, Type 8
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of breast cancer
Immunohistochemical expression of EpCAM and P53 in IDC of the breast
Measured: two day after staining sections with Immnnohistochemical markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast CancerStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Mokhtar Abdelkareem, Sohag University
- Investigators
- Rasha M Abdelkareem, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703815
- Sponsor's protocol ID
- Soh-Med-23-01-34
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EpCAM and p53 Expressions in Infiltrating Duct Carcinoma of the Breast and Their Association With the Clinicopathological Prognostic Paremeters
- ClinicalTrials.gov ID
- NCT05703815
- Acronym / sponsor ID
- Soh-Med-23-01-34
- Conditions
- Invasive Breast Cancer
- Keywords
- EpCAM, P53 , IDC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 30 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 represents the most frequently diagnosed cancer in women. It represents the 5th leading cause of cancer mortality all over the world.
In Egypt, breast cancer represents the 2nd most diagnosed cancer among all population. But among Egyptian females it represents the 1st diagnosed cancer representing 32.4%.
The main cause of death in breast cancer patients is tumor metastasis. Although only 5-10% of recently diagnosed breast cancer cases show metastasis to distant sites, but still there is a high risk for metastasis in patients with localized primary tumor following successful surgical management.
Epithelial cell adhesion molecule (EpCAM) is a cell adhesion molecule. It modifies cadherin mediated cell adhesion and it induces epithelial cell migration and proliferation. Some authors elucidate that EpCAM is involved in metastasis.
P53 is a known tumor suppressor gene involved in the control of cell cycle, DNA repair and apoptosis. It's one of the most mutated genes in cancer including breast cancer. Mutant p53 has a big role in tumor progression.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- formalin-fixed and paraffin embedded tissue blocks from 40 patients with breast cancer
Key inclusion criteria (2 listed)
- Both incisional and excisional biopsy specimens. 2. All the studied cases include sufficient materials for the immunohistochemical study.
- 3. Complete clinical data.
Key exclusion criteria (3 listed)
- Patients with recurrence of the primary tumor.
- Patients with a history of preoperative chemotherapy and/or radiotherapy.
- Insufficient or tiny tissue biopsies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of breast cancer
Time frame: two day after staining sections with Immnnohistochemical markers
Immunohistochemical expression of EpCAM and P53 in IDC of the breast
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- 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.
Rasha M Abdelkareem principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Breast Cancer, run by Sohag University.
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 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 31 Jan 2023. 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 Rasha M Abdelkareem, lecturer (01158408563, rasha_abdelkareem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of breast cancer (time frame: two day after staining sections with Immnnohistochemical markers). 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 31 Jan 2023.