الفهرس 
Acknowledgement
EpidemiologyOnly 14 pages are availabe for public view
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Abstract
This study was conducted on one hundred informed and consented (according to the guidelines of the ethical committee of Faculty of Medicine, Assiut University) female individuals. 80 patients with breast cancer aged from 20 to 71 years old attending the Surgical Oncology Department, South Egypt Cancer Institute, Assiut University, were recruited as study cases. Serum glucose, Kidney function tests, Liver function tests, Peripheral haemogram, prothrombin time & concentration, abdominal ultrasound and bone scan were done for all patients. MRI was done for patients with stage IV. Twenty apparently healthy female individuals were included in this study as the control group for comparison. Their age ranged from 19 to 69 years with normal clinical examination, normal bilateral breast mammography, normal chest x-ray and normal abdominal ultrasound.
They were classified into:-
Control group :
• Group 1 : 20 healthy controls aged ( 19 to 69 years ) from healthy volunteers after informed consent .
Patient groups:
• Group 2: Stage I breast cancer : 20 patients .
• Group 3: Stage II breast cancer : 20 patients .
• Group 4: Stage III breast cancer : 20 patients .
• Group 5 : Stage IV breast cancer : 20 patients .
The following specific investigations were done for all the studied persons:-
1- Cancer Antigen 15-3 (CA 15-3).
2-Carcinoembryonic Antigen (CEA).
3-Cytokeratin-19 mRNA by Real-time polymerase chain reaction (RT-PCR ).
4- Mammaglobin mRNA by Real-time polymerase chain reaction (RT-PCR ).
Findings of this study:-
1) Carcinoma Antigen 15-3 (CA15-3) level :
None of the healthy females in control group (group1) (0.0%) had elevated CA15-3 level above the cut-off value which was 29.69 IU/mL.
In group 2 (stage I breast cancer) 20% of the patients had elevated levels of CA15-3. In group 3 (stage II breast cancer) 35% of the patients had elevated levels of CA15-3. In group 4 (stage III breast cancer) 60% of the patients had elevated levels of CA15-3. In group 5 (stage IV breast cancer) 50% of the patients had elevated levels of CA15-3.
2) Carcinoembryonic Antigen (CEA) level :
None of the healthy females in control group (group1) (0.0%) had elevated CEA above the cut-off value which was 4.84 ng/mL.
In group 2 (stage I breast cancer) 25% of the patients had elevated levels of CEA. In group 3 (stage II breast cancer) 20% of the patients had elevated levels of CEA. In group 4 (stage III breast cancer) 75% of the patients had elevated levels of CEA. In group 5 (stage IV breast cancer) 75% of the patients had elevated level of CEA.
3) CytoKeratin-19 (CK-19) level :
None of the healthy females in control group (group1) (0.0%) had elevated CK-19 level above the cut-off value which was 1.0 .
There were two samples with undetected results for GAPDH and CK-19. One of them was in group 3 and the other was in group 4.
In group 2 (stage I breast cancer) 35% of the patients had elevated level of CK-19. In group 3 (stage II breast cancer) 47.4% of the patients had elevated level of CK-19. In group 4 (stage III breast cancer) 68.4% of the patients had elevated level of CK-19. In group 5 (stage IV breast cancer) 95% of the patients had elevated level of CK-19.
4) Mammaglobin level :
None of the healthy females in control group (group1) (0.0%) had elevated mammaglobin level above the cut-off value which was 1.0 .
There are two samples with undetected results for GAPDH and mammaglobin. One of them is in group 3 and the other is in group 4.
In group 2 (stage I breast cancer) 20% of the patients had elevated level of mammaglobin. In group 3 (stage II breast cancer) 47.4% of the patients had elevated level of mammaglobin. In group 4 (stage III breast cancer) 73.7% of the patients had elevated level of mammaglobin. In group 5 (stage IV breast cancer) 95% of the patients had elevated level of mammaglobin.
Correlation of CA15-3, CEA, CK-19 and mammaglobin with tumour staging:
There was high statistical significant difference between the normal control group (group 1) and patients groups (groups 2, 3, 4, 5) as regard CA15-3 level (mean ± SE).
There was a positive correlation between the level of CA15-3 and the advancement of the breast cancer represented by the increase in the clinical staging of the disease (groups 2, 3, 4). However, inspite that CA15-3 level (mean ± SE) in group 5 (stage VI breast cancer) was higher than that in group 3 (stage II breast cancer), but no statistical significant difference was detected. Also, no statistical significant difference was detected in a comparison between group 4 (stage III breast cancer) versus group 5 (stage VI breast cancer). By comparing patients with distant metastasis (group 5) versus patients free of distant metastasis (groups 2, 3, 4), there was no statistical significant difference inspite that CA15-3 level (mean ± SE) in group 5 (stage VI breast cancer) was higher than that in groups 2, 3, 4 (stages I, II, III).
There was high statistical significant difference between the normal control group (group 1) and patients groups (groups 3, 4, 5) as regard CEA level (mean ± SE). However, inspite that CEA level (mean ± SE) in group 2 (stage I breast cancer) was higher than that in normal control group (group 1), but no statistical significant difference was detected.
The correlation between the level of CEA and the advancement of the breast cancer represented by the increase in the clinical staging of the disease, showed that there was no statistical significant difference detected in a comparison between group 2 (stage I breast cancer) and group 3 (stage II breast cancer) inspite that CEA level (mean ± SE) in group 3 (stage II breast cancer) was higher than that in group 2 (stage I breast cancer). Also, there was no statistical significant difference detected in a comparison between group 4 (stage III breast cancer) and group 5 (stage VI breast cancer).
By comparing patients with distant metastasis (group 5) versus patients free of distant metastasis (groups 2, 3, 4), (table 24), there was no statistical significant difference inspite that CEA level (mean ± SE) in group 5 (stage VI breast cancer) was higher than that in groups 2, 3, 4 (stage I, II, III).
there was a statistical significant difference between the normal control group (group 1) and patients groups (groups 3, 4, 5) as regard CK-19 level (mean ± SE), (Table 28). However, inspite that CK-19 level (mean ± SE) in group 2 (stage I breast cancer) was higher than that in normal control group (group 1), but no statistical significant difference was detected.
There was a positive correlation between the level of CK-19 and the advancement of the breast cancer represented by the increase in the clinical staging of the disease (groups 2 : 5).
By comparing patients with distant metastasis (group 5) versus patients free of distant metastasis (groups 2, 3, 4), there was a high statistical significant difference.
There was a statistical significant difference between the normal control group (group 1) and patients groups (groups 3, 4, 5) as regard mammaglobin level (mean ± SE). However, inspite that mammaglobin level (mean ± SE) in group 2 (stage I breast cancer) was higher than that in normal control group (group 1), but no statistical significant difference was detected.
There was a positive correlation between the level of mammaglobin and the advancement of the breast cancer represented by the increase in the clinical staging of the disease (groups 2 : 5).
By comparing patients with distant metastasis (group 5) versus patients free of distant metastasis (groups 2, 3, 4), there was a high statistical significant difference.
Correlation of CA15-3, CEA, CK-19 and mammaglobin with each other:
There was a significant positive correlation in a comparison between CK-19 positivity with CEA and CA 15-3 concentrations. There was a significant positive correlation in a comparison between mammaglobin positivity with CEA and CA 15-3 concentrations.
Sensitivity and specificity of CA15-3, CEA, CK-19 and Mammaglobin:
The combination CA15-3, CK-19 and mammaglobin resulted in the highest sensitivity (97.5 %), the highest specificity (95%) and the highest diagnostic accuracy (97%). The same sensitivity, specificity and diagnostic accuracy were also resulted when CA15-3, CEA, CK-19 and mammaglobin were combined together.