BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary

NCT ID: NCT06304922

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-04-01

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. But,the 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 e.g., 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 (6.3%).

The absence of BRCA1/2 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 BRCA1/2-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 condition/performance 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.

Conditions

Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer

Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age above 18 years,
• Pathologically proven ovarian cancer,epithelial origin.
• BRCA mutant/wild
• Recurrent cases who are eligible to anti-VEGF (Bevacizumab).
• Patients with clinical stages T1-T3c , N0-N1b, M0, and recurrent platinum sensitive cases.
• Patients with good renal and liver functions.
• No other malignancy (double malignancy).
• Performance status 0-2 according to ECOG performance status scale.

Exclusion Criteria

• Performance status 3-4 according to ECOG performance status scale.
• Patients refuse to receive chemotherapy,
• Patients not eligible to receive chemotherapy due to liver or renal impairment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Nesreen Haidra Ahmed Garad

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nesreen Haidra Garad, MD/PhD

Role: CONTACT

Nesreengarad@gmail.com

00966-547-210-285

Hanan Gamal Mustafa, MD/PhD

Role: CONTACT

mostafahanan36@yahoo.com

0020-100408-2002

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Other Identifiers

BRCA 1/2 in cancer ovary

Identifier Type: -

Identifier Source: org_study_id