Breast CancerNCT06097546
Serum Retinoic Acid Induced Protein 14 (RAI14) and Metastasis Associated Cancer Colon -1 (MACC-1) in Breast Cancer
An observational study of Breast Cancer, run by Assiut University.
Trial summary
1. Measurement of serum levels of Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) as biomarkers for diagnosis of breast cancer. 2. Study their relationship to disease stages and clinicopathological features of BC. 3. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- laboratory test (RAI14 and MACC-1 )
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to Dec 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 Any age
- Women only
- Child, Adult, Older adult
Study population: The study will be carried out on 3 groups * Group (1)(patient group): 30 newly diagnosed patients with breast cancer, who will be admitted Clinical Pathology Department, Assiut University Hospitals, Assiut University Patients group will be furtherly subclassified according to the TNM staging classification . * Group (2) (benign lesions) 30 diagnosed patients with benign breast lesions. * Group (3) (control group): 30 apparently healthy individuals with matched age and sex are included in this study as a control group for comparison.
Who may be able to join
- Patients with benign breast lesions.
- Patients with breast cancer who were confirmed by histopathological studies and did not receive any treatment.
- Exclusion Criteria: 1- Patients who received chemotherapy or radiotherapy. 2- Patients with known other organ malignancy.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Serum Retinoic Acid Induced Protein 14 (RAI14) and Metastasis Associated Cancer Colon -1 (MACC-1) as Biomarkers for Breast Cancer
- Measurement of serum levels of Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) as biomarkers for diagnosis of breast cancer.
- Study their relationship to disease stages and clinicopathological features of BC.
- Compare the diagnostic performance of serum RAI14 and serum MACC-1 with serum Carcinoembryonic antigen (CEA) and Cancer antigen 15-3 (CA15-3) for diagnosis of BC.
Read the detailed description
Breast cancer (BC) is one of the most prevalent Neoplasms and the second leading reason of death from cancer in women. Every year approximately 2.3 million new cases of BC are diagnosed worldwide. Due to the high impact of this type of cancer, the early detection, early diagnosis and effective treatment, will improve the diagnosis of patients and lower the associated mortality rates. Carcinoembryonic antigen (CEA) and Cancer antigen 15-3 (CA15-3) are the most commonly used serum markers in the diagnosis and follow up of BC, However their clinical applications still remain controversial.
Retinoic acid induced protein 14 (RAI14) is an actin-binding protein which participates in physiological processes such as the regulation of cell polarity and transport of spermatozoa. Recent studies showed that RAI14 is overexpressed in several malignant tumors with a significant role in the development of tumors . The serum RAI14 is a reliable novel marker in the early diagnosis and chemotherapy monitoring of triple-negative BC.
Metastasis-associated colon cancer-1 (MACC-1) is a newly identified tumor marker, first identified in colon cancer tissue as a prognostic indicator and inducer of metastasis .It is located on human chromosome 7 (7p21.1) and shown to be a key regulator of the hepatocyte growth factor-mesenchymal epithelial transition factor( HGF-MET) pathway in colon cancer. It is shown that serum MACC-1 can be a potential biomarker for diagnosis and progression in patients with BC. There was a strong correlation between MACC-1 expression and the clinical and the primary tumor, regional nodes, metastasis (TNM) stages of BC.
- Conditions
- Breast Cancer
- Being tested
- laboratory test (RAI14 and MACC-1 )
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory test (RAI14 and MACC-1 )Diagnostic test
Measurement of serum RAI14 and serum MACC-1 levels by immunochemical assays
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | Newly diagnosed patients with breast cancer Receives: Diagnostic Test: laboratory test (RAI14 and MACC-1 ) | |
| Benign lesions | Diagnosed patients with benign breast lesions Receives: Diagnostic Test: laboratory test (RAI14 and MACC-1 ) | |
| Control | apparently healthy individuals with matched age and sex Receives: Diagnostic Test: laboratory test (RAI14 and MACC-1 ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the diagnostic value of serum Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) for breast cancer patients.
Evaluation of the clinical utility of measurement of level of Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) in newly diagnosed breast cancer patients
Measured: Baseline
Secondary outcomes (1)
Correlate the levels of serum Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) with the TNM staging in breast cancer patients.
Studying the correlation of levels of serum Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) with the TNM staging in breast cancer patient.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Atef Mohamed Elbadry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097546
- Sponsor's protocol ID
- Markers in Breast Cancer
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cui R, Zou J, Zhao Y, Zhao T, Ren L, Li Y. The dual-crosslinked prospective values of RAI14 for the diagnosis and chemosurveillance in triple negative breast cancer. Ann Med. 2023 Dec;55(1):820-836. doi: 10.1080/07853890.2023.2177722.
PubMed 36880986Lv M, Jiao Y, Yang B, Ye M, Di W, Su W, Zhong J. MACC1 as a Potential Target for the Treatment and Prevention of Breast Cancer. Biology (Basel). 2023 Mar 16;12(3):455. doi: 10.3390/biology12030455.
PubMed 36979146Ahmed M, Aslam M. Serum MACC-1: a new biomarker for breast cancer. Oncotarget. 2020 Dec 1;11(48):4521-4526. doi: 10.18632/oncotarget.27813. eCollection 2020 Dec 1.
PubMed 33400729
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Retinoic Acid Induced Protein 14 (RAI14) and Metastasis Associated Cancer Colon -1 (MACC-1) as Biomarkers for Breast Cancer
- ClinicalTrials.gov ID
- NCT06097546
- Acronym / sponsor ID
- Markers in Breast Cancer
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Oct 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.
- Measurement of serum levels of Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) as biomarkers for diagnosis of breast cancer.
- Study their relationship to disease stages and clinicopathological features of BC.
- Compare the diagnostic performance of serum RAI14 and serum MACC-1 with serum Carcinoembryonic antigen (CEA) and Cancer antigen 15-3 (CA15-3) for diagnosis of BC.
Detailed description
Breast cancer (BC) is one of the most prevalent Neoplasms and the second leading reason of death from cancer in women. Every year approximately 2.3 million new cases of BC are diagnosed worldwide. Due to the high impact of this type of cancer, the early detection, early diagnosis and effective treatment, will improve the diagnosis of patients and lower the associated mortality rates. Carcinoembryonic antigen (CEA) and Cancer antigen 15-3 (CA15-3) are the most commonly used serum markers in the diagnosis and follow up of BC, However their clinical applications still remain controversial.
Retinoic acid induced protein 14 (RAI14) is an actin-binding protein which participates in physiological processes such as the regulation of cell polarity and transport of spermatozoa. Recent studies showed that RAI14 is overexpressed in several malignant tumors with a significant role in the development of tumors . The serum RAI14 is a reliable novel marker in the early diagnosis and chemotherapy monitoring of triple-negative BC.
Metastasis-associated colon cancer-1 (MACC-1) is a newly identified tumor marker, first identified in colon cancer tissue as a prognostic indicator and inducer of metastasis .It is located on human chromosome 7 (7p21.1) and shown to be a key regulator of the hepatocyte growth factor-mesenchymal epithelial transition factor( HGF-MET) pathway in colon cancer. It is shown that serum MACC-1 can be a potential biomarker for diagnosis and progression in patients with BC. There was a strong correlation between MACC-1 expression and the clinical and the primary tumor, regional nodes, metastasis (TNM) stages of BC.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | Diagnostic Test: laboratory test (RAI14 and MACC-1 )Newly diagnosed patients with breast cancer |
| Benign lesions | – | Diagnostic Test: laboratory test (RAI14 and MACC-1 )Diagnosed patients with benign breast lesions |
| Control | – | Diagnostic Test: laboratory test (RAI14 and MACC-1 )apparently healthy individuals with matched age and sex |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be carried out on 3 groups * Group (1)(patient group): 30 newly diagnosed patients with breast cancer, who will be admitted Clinical Pathology Department, Assiut University Hospitals, Assiut University Patients group will be furtherly subclassified according to the TNM staging classification . * Group (2) (benign lesions) 30 diagnosed patients with benign breast lesions. * Group (3) (control group): 30 apparently healthy individuals with matched age and sex are included in this study as a control group for comparison.
Key inclusion criteria (3 listed)
- Patients with benign breast lesions.
- Patients with breast cancer who were confirmed by histopathological studies and did not receive any treatment.
- Exclusion Criteria: 1- Patients who received chemotherapy or radiotherapy. 2- Patients with known other organ malignancy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| laboratory test (RAI14 and MACC-1 )Measurement of serum RAI14 and serum MACC-1 levels by immunochemical assays | Diagnostic test | Benign lesions, Breast cancer patients, Control |
Primary outcome
Evaluate the diagnostic value of serum Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) for breast cancer patients.
Time frame: Baseline
Evaluation of the clinical utility of measurement of level of Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) in newly diagnosed breast cancer patients
1 secondary outcome
Correlate the levels of serum Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) with the TNM staging in breast cancer patients.
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 24 Oct 2023.
- Background: PubMed 36880986Cui R, Zou J, Zhao Y, Zhao T, Ren L, Li Y. The dual-crosslinked prospective values of RAI14 for the diagnosis and chemosurveillance in triple negative breast cancer. Ann Med. 2023 Dec;55(1):820-836. doi: 10.1080/07853890.2023.2177722.
- Background: PubMed 36979146Lv M, Jiao Y, Yang B, Ye M, Di W, Su W, Zhong J. MACC1 as a Potential Target for the Treatment and Prevention of Breast Cancer. Biology (Basel). 2023 Mar 16;12(3):455. doi: 10.3390/biology12030455.
- Background: PubMed 33400729Ahmed M, Aslam M. Serum MACC-1: a new biomarker for breast cancer. Oncotarget. 2020 Dec 1;11(48):4521-4526. doi: 10.18632/oncotarget.27813. eCollection 2020 Dec 1.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut 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 3 inclusion and 0 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 24 Oct 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 Alaa Atef, MD (01114341538, alaa.atef_2012@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the diagnostic value of serum Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) for breast cancer patients. (time frame: Baseline). 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 NCT06097546, which also lists 3 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 24 Oct 2023.