Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657638
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
Cytological Examination of Malignant Pleural Effusion in Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diagnostic Yield of Cytological Examination of Malignant Pleural Effusion in Different Breast Cancer Pathologies
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Malignant pleural effusion MPE is characterized by the presence of malignant cells It can occur in 15 of patients with cancer and is a common manifestation in patients with metastatic disease
Breast cancer BC is the second most common cause of MPE and MPE occurring in 2- 11 of patients with BC Breast cancer is a heterogeneous disease of malignant tumors with diversified morphology clinical course biologic behavior and prognosis and accurate tumor classification is critical for a patients care
Breast cancer BC is the second most common cause of MPE and MPE occurring in 2- 11 of patients with BC Breast cancer is a heterogeneous disease of malignant tumors with diversified morphology clinical course biologic behavior and prognosis and accurate tumor classification is critical for a patients care
Detailed Description:
The serous pleural cavity is an enclosed space covered by the parietal and visceral layers of serous membranes which are lined by a monolayer of mesothelial cells supported on fibrous tissue rich in capillaries and lymphatic Under physiological conditions these two layers are in juxtaposition and only a small amount of fluid is Present inside these compartments acting as a lubricant to avoid friction
Many infectious benign and malignant diseases can cause pleural effusion Approximately one-fourth of all pleural effusions and 30 - 70 of all exudative effusions in hospital settings are secondary to cancer
Lung cancer is the most common metastatic tumor to the pleura in men while breast cancer is the most common tumor in women
Breast cancer is the most commonly diagnosed malignant tumor in women worldwide and the most common cause of malignancy- related deaths Breast cancer patients constitute approximately 36 of all oncological patients The incidence of breast cancer is gradually increasing worldwide
Since breast cancer is a heterogeneous disease that varies from clinical course to molecular subtypes it includes a wide spectrum of diseases with different presentations and morphological biological and clinical phenotypes Therefore the behavior and treatment success of breast cancer vary greatly from person to person and as a result it is possible to encounter very different personalized prognosis processes in breast cancer patients
Malignant pleural effusions are most commonly caused by carcinomas of lung breast gastrointestinal tract or ovary and hematological malignancies Diagnosis of pleural effusion is done by many maneuvers as simple aspiration for cytological examination or using more invasive maneuvers as closed pleural biopsy and medical thoracoscopy Large studies evaluated the sensitivity and specificity of conventional cytology for the detection of malignant cells in effusions ranging from 40 to 80 and 89 to 98 respectively
Molecular classification of breast cancer was developed based on the use of complementary DNA microarrays to represent human genes Breast cancer was divided into 4 intrinsic molecular subtypes luminal A luminal B v-erb-b2 ERBB2human epithelial growth factor receptor 2 HER2 gene-overexpressing HER2 and basal-like
The presence of MPE in advanced cancer is associated with poor prognosis and the range of overall survival OS time is from 5 to 13 months MPE is most common in triple-negative breast cancer TNBC and TNBC phenotype is an unfavorable characteristic in patients with MPE worsening the prognosis and reducing life expectancy For symptomatic patients with MPE it is recommended to use an indwelling pleural catheter or chemical pleurodesis combined with systemic treatment
Several factors could be attributed to this great variability such as different immune-cytochemical staining techniques dilutions and type of antibody clone used volume of sample procedural technique and the experience of the examiner In addition lack of uniformity in reporting such specimens could also be a factor for such wide differences in overall values of sensitivity and specificity among studies with no study yet to the best of our knowledge reporting risk of malignancy ROM of defined diagnostic categories in pleural fluids
For the time being no international recommendations have been made about the rationale of using anti-tumor therapy against standard palliative MPE treatment procedures The clinical treatment response of MPE is poor in systemic anti-tumor therapy in most malignant conditions Therefore there is an urgent need to develop a viable and reliable method to improve therapeutic effects of BC patients with MPE
Therefore the current study presents our experience with pleural effusion cytology samples at our hospital using a diagnostic system and reporting ROM for each defined category as well as use of immunohistochemistry and overall sensitivity and specificity of cytology when compared to concomitant pleural biopsies
Many infectious benign and malignant diseases can cause pleural effusion Approximately one-fourth of all pleural effusions and 30 - 70 of all exudative effusions in hospital settings are secondary to cancer
Lung cancer is the most common metastatic tumor to the pleura in men while breast cancer is the most common tumor in women
Breast cancer is the most commonly diagnosed malignant tumor in women worldwide and the most common cause of malignancy- related deaths Breast cancer patients constitute approximately 36 of all oncological patients The incidence of breast cancer is gradually increasing worldwide
Since breast cancer is a heterogeneous disease that varies from clinical course to molecular subtypes it includes a wide spectrum of diseases with different presentations and morphological biological and clinical phenotypes Therefore the behavior and treatment success of breast cancer vary greatly from person to person and as a result it is possible to encounter very different personalized prognosis processes in breast cancer patients
Malignant pleural effusions are most commonly caused by carcinomas of lung breast gastrointestinal tract or ovary and hematological malignancies Diagnosis of pleural effusion is done by many maneuvers as simple aspiration for cytological examination or using more invasive maneuvers as closed pleural biopsy and medical thoracoscopy Large studies evaluated the sensitivity and specificity of conventional cytology for the detection of malignant cells in effusions ranging from 40 to 80 and 89 to 98 respectively
Molecular classification of breast cancer was developed based on the use of complementary DNA microarrays to represent human genes Breast cancer was divided into 4 intrinsic molecular subtypes luminal A luminal B v-erb-b2 ERBB2human epithelial growth factor receptor 2 HER2 gene-overexpressing HER2 and basal-like
The presence of MPE in advanced cancer is associated with poor prognosis and the range of overall survival OS time is from 5 to 13 months MPE is most common in triple-negative breast cancer TNBC and TNBC phenotype is an unfavorable characteristic in patients with MPE worsening the prognosis and reducing life expectancy For symptomatic patients with MPE it is recommended to use an indwelling pleural catheter or chemical pleurodesis combined with systemic treatment
Several factors could be attributed to this great variability such as different immune-cytochemical staining techniques dilutions and type of antibody clone used volume of sample procedural technique and the experience of the examiner In addition lack of uniformity in reporting such specimens could also be a factor for such wide differences in overall values of sensitivity and specificity among studies with no study yet to the best of our knowledge reporting risk of malignancy ROM of defined diagnostic categories in pleural fluids
For the time being no international recommendations have been made about the rationale of using anti-tumor therapy against standard palliative MPE treatment procedures The clinical treatment response of MPE is poor in systemic anti-tumor therapy in most malignant conditions Therefore there is an urgent need to develop a viable and reliable method to improve therapeutic effects of BC patients with MPE
Therefore the current study presents our experience with pleural effusion cytology samples at our hospital using a diagnostic system and reporting ROM for each defined category as well as use of immunohistochemistry and overall sensitivity and specificity of cytology when compared to concomitant pleural biopsies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None