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Trial Title:
Breast Cancer After Ovarian Cancer During and/or After Therapy: Genomic Evaluation
NCT ID:
NCT05763472
Condition:
BRCA-Associated Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
BRCA1/2
Breast cancer
Ovarian cancer
Platinum salts
PARP inhibitors
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Genetic
Intervention name:
Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).
Description:
Next-generation sequencing (NGS) analysis with TruSight Oncology 500 (TSO 500) is
performed on tumor samples from breast and ovarian cancer of the enrolled patients.
Arm group label:
Patients with germline BRCA1/2 patitents
Summary:
This study will investigate, in patients with germline BRCA-1/2 mutations and breast
cancer, arising during and / or after treatment with platinum-based chemotherapy and / or
with PARP-inhibitors for ovarian cancer, the presence of molecular alterations
potentially involved in the mechanisms of resistance to antineoplastic treatment on
breast and ovarian tumor tissue.
Criteria for eligibility:
Study pop:
Patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or
after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for
ovarian cancer
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Written informed consent.
- Age older than 18 years.
- Germline BRCA1/2 mutation.
- Histologically confirmed ovarian cancer treated with platinum-based chemotherapy
and/or PARP inhibitors.
- Histologically confirmed breast cancer occurred during or after therapy with
platinum-based agents and/or PARP-inhibitors for ovarian cancer.
- Availability of FFPE breast and ovarian tumor samples.
Exclusion Criteria:
- Other malignancies in the last 2 years.
- Prior chemotherapy or radiation therapy for other malignancies.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
IDA PARIS, MD
Phone:
+39 0630156493
Email:
ida.paris@policlinicogemelli.it
Start date:
March 1, 2022
Completion date:
June 1, 2023
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05763472
