Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304922
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Brief Title:
BRCA 12 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
BRCA 12 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer
Detailed Description:
Ovarian cancer was the third most common gynecological cancer globally in 2020 Ovarian carcinoma is the most common type of ovarian cancer comprising over 90 of all ovarian cancer cases
It is the most lethal gynecologic malignancy in high-income countries
Approximately 10-15 of epithelial ovarian cancer EOC patients carry germline mutation in BRCA1 or BRCA2 Butthe majority of cases are sporadic
Increased body mass index BMI and hormone replacement therapy HRT have been proposed as major contributors along with smoking and occupational hazards eg asbestos exposure
Studies have reported that the prevalence of BRCA mutations varies among different epithelial ovarian ca EOC subtypes with prevalence of 20-25 reported for the high-grade serous subtype BRCA mutations were reported in 10 of the endometrioid subtype and with very low frequency in clear cell subtype 63
The absence of BRCA12 function is associated with a cumulative lifetime risk for developing epithelial ovarian cancer of 40 to 50 in patients who are BRCA1-mutation carriers and 20 to 25 in patients who are BRCA2-mutation carriers
Improved prognosis in terms of progression-free survival PFS and overall survival OS with higher partial response PR and complete response CR rates to platinum-containing regimens and longer treatment-free intervals has been observed in retrospective studies of patients who are BRCA12-mutant carriers with ovarian cancer compared with patients who are non
However despite a generally favorable response to first-line chemotherapy the disease frequently recurs Due to limited therapeutic options sequential chemotherapy regimens are often used based on platinum sensitivity determined by the platinum-free interval residual toxicities general conditionperformance status and co-morbidities with suboptimal outcomes and cumulative toxicity Treatment effectiveness decreases over time with resistance to platinum drugs precluding diminished survival and quality of life
Germ-line BRCA mutations are associated with longer survival rates after ovarian cancer diagnosis and generally favorable response to platin-based therapy
No data available for recurrent cases to assess the response of platinum based chemotherapy in BRCA mutant or wild cases
It is the most lethal gynecologic malignancy in high-income countries
Approximately 10-15 of epithelial ovarian cancer EOC patients carry germline mutation in BRCA1 or BRCA2 Butthe majority of cases are sporadic
Increased body mass index BMI and hormone replacement therapy HRT have been proposed as major contributors along with smoking and occupational hazards eg asbestos exposure
Studies have reported that the prevalence of BRCA mutations varies among different epithelial ovarian ca EOC subtypes with prevalence of 20-25 reported for the high-grade serous subtype BRCA mutations were reported in 10 of the endometrioid subtype and with very low frequency in clear cell subtype 63
The absence of BRCA12 function is associated with a cumulative lifetime risk for developing epithelial ovarian cancer of 40 to 50 in patients who are BRCA1-mutation carriers and 20 to 25 in patients who are BRCA2-mutation carriers
Improved prognosis in terms of progression-free survival PFS and overall survival OS with higher partial response PR and complete response CR rates to platinum-containing regimens and longer treatment-free intervals has been observed in retrospective studies of patients who are BRCA12-mutant carriers with ovarian cancer compared with patients who are non
However despite a generally favorable response to first-line chemotherapy the disease frequently recurs Due to limited therapeutic options sequential chemotherapy regimens are often used based on platinum sensitivity determined by the platinum-free interval residual toxicities general conditionperformance status and co-morbidities with suboptimal outcomes and cumulative toxicity Treatment effectiveness decreases over time with resistance to platinum drugs precluding diminished survival and quality of life
Germ-line BRCA mutations are associated with longer survival rates after ovarian cancer diagnosis and generally favorable response to platin-based therapy
No data available for recurrent cases to assess the response of platinum based chemotherapy in BRCA mutant or wild cases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None