PIK3CA Mutational Status Assessment

PIK3CA Mutational Status Assessment: Towards a "Tailored" Diagnostic Approach

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06706570

Enrollment

100

Registered

2024-11-26

Start date

2024-11-06

Completion date

2030-12-31

Last updated

2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Metastatic

Brief summary

Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.

Detailed description

Evaluate the effectiveness and concordance of molecular methods in identifying mutations affecting the PIK3CA gene both on paraffin tissue sections of the tumor and on liquid biopsy of patients with breast cancer treated at the IEO. The molecular test on the liquid biopsy of same patient could bring an important benefit considering that the withdrawal of this biomaterial turns out to be less invasive than a biopsy performed on an organ

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory. * Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing. * Participants should be at advanced or metastatic setting prior to treatment. * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion. * Patients must be accessible for follow-up.

Exclusion criteria

• patients already treated with different treatments like chemotherapy, hormone therapy etc

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of PIK3CA mutational status: a path towards a "tailored" diagnostic approach.	2 years	Investigate concordance between sequencing panels again generation (NGS) based on different principles and different RT-PCR assays in detecting mutations of PIK3CA.

Countries

Italy

Contacts

CONTACTNicola Fusco, MD

nicola.fusco@ieo.it00390294372079

CONTACTfrancesca lombardi, biologist

francesca.lombardi@ieo.it00390257489425

PRINCIPAL_INVESTIGATORNicola Fusco, MD

Istituto Europeo di Oncologia

Outcome results