PIK3CA Mutational Status Assessment

NCT ID: NCT06706570

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-06

Study Completion Date

2030-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Breast Cancer Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicola Fusco, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Europeo di Oncologia

Locations

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European Institute of Oncology

Milan, MI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Nicola Fusco, MD

Role: CONTACT

00390294372079

francesca lombardi, biologist

Role: CONTACT

00390257489425

Facility Contacts

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Nicola Fusco, MD

Role: primary

00390294372079

Other Identifiers

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IEO 2029

Identifier Type: -

Identifier Source: org_study_id

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