Breast CancerNCT06134570
ALDH1A1 Expression in Invasive Mammary Carcinoma
An observational study of Breast Cancer, run by Sohag University at 1 site in Egypt.
Trial summary
ALDH1A1 isozyme oxidizes Retinaldehyde to retinoic acid, which regulates the expression of the genes involved in tumor-initiating stem-like cells, thereby initiating tumor growth and resistance to drugs. Much emphasis has been focused on ALDH1A1 as a CSC marker. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Jun 2024
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: sixty paraffin blocks of breast carcinoma collected from the archive of Pathology Department of Sohag Faculty of Medicine
Who may be able to join
- Patients with invasive mammary carcinoma carcinoma and underwent surgery
Who cannot join
- Cases received pre-operative chemotherapy or radiotherapy.
- Cases with insufficient clinical data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ALDH1A1 as A Stem Cell Marker and Its Correlation With the Clinico-pathological Parameters in Invasive Mammary Carcinoma
ALDH1A1 isozyme oxidizes Retinaldehyde to retinoic acid, which regulates the expression of the genes involved in tumor-initiating stem-like cells, thereby initiating tumor growth and resistance to drugs.
Much emphasis has been focused on ALDH1A1 as a CSC marker. High expression of ALDH1A1 has been reported as a poor prognostic marker in several tumor types and is associated with poor patient outcomes .
Read the detailed description
Breast cancer is one of the most common cancers among women. it is a heterogenous disease. several factors affect the prognosis of breast cancer. CSCs markers are one of the emerging prognostic biomarkers.
ALDH1A1 isozyme oxidizes Retinaldehyde to retinoic acid, which regulates the expression of the genes involved in tumor-initiating stem-like cells, thereby initiating tumor growth and resistance to drugs.
Much emphasis has been focused on ALDH1A1 as a CSC marker. High expression of ALDH1A1 has been reported as a poor prognostic marker in several tumor types and is associated with poor patient outcomes .
- Conditions
- Breast Cancer
- Keywords
- breast cancer, CSCs, ALDH1A1
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate expression of ALDH1A1 in invasive mammary carcinoma
immunohistochemical study
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Oct 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (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.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagwa Abd El-Sadek Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134570
- Sponsor's protocol ID
- Soh-Med-23-09-21PD
- Status last verified
- Oct 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALDH1A1 as A Stem Cell Marker and Its Correlation With the Clinico-pathological Parameters in Invasive Mammary Carcinoma
- ClinicalTrials.gov ID
- NCT06134570
- Acronym / sponsor ID
- Soh-Med-23-09-21PD
- Conditions
- Breast Cancer
- Keywords
- breast cancer, CSCs, ALDH1A1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 18 Nov 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.
ALDH1A1 isozyme oxidizes Retinaldehyde to retinoic acid, which regulates the expression of the genes involved in tumor-initiating stem-like cells, thereby initiating tumor growth and resistance to drugs.
Much emphasis has been focused on ALDH1A1 as a CSC marker. High expression of ALDH1A1 has been reported as a poor prognostic marker in several tumor types and is associated with poor patient outcomes .
Detailed description
Breast cancer is one of the most common cancers among women. it is a heterogenous disease. several factors affect the prognosis of breast cancer. CSCs markers are one of the emerging prognostic biomarkers.
ALDH1A1 isozyme oxidizes Retinaldehyde to retinoic acid, which regulates the expression of the genes involved in tumor-initiating stem-like cells, thereby initiating tumor growth and resistance to drugs.
Much emphasis has been focused on ALDH1A1 as a CSC marker. High expression of ALDH1A1 has been reported as a poor prognostic marker in several tumor types and is associated with poor patient outcomes .
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- sixty paraffin blocks of breast carcinoma collected from the archive of Pathology Department of Sohag Faculty of Medicine
Key inclusion criteria (1 listed)
- Patients with invasive mammary carcinoma carcinoma and underwent surgery
Key exclusion criteria (2 listed)
- Cases received pre-operative chemotherapy or radiotherapy.
- 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.
Primary outcome
evaluate expression of ALDH1A1 in invasive mammary carcinoma
Time frame: 4 month
immunohistochemical study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 1 inclusion and 2 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 18 Nov 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?
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?
evaluate expression of ALDH1A1 in invasive mammary carcinoma (time frame: 4 month). 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 18 Nov 2023.