Detection of Germline and Somatic Pathogenic Variants in Patients With de Novo Metastatic Breast Cancer

April 6, 2023 updated by: Hellenic Cooperative Oncology Group
To determine somatic and germline pathogenic variants in patients with denovo metastatic breast cancer in order to map the molecular/genetic characteristics of DN- MBC aiming in comprehending the biology and highlighting potential novel treatment options for the disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The value of this study is based on the fact that DN-MBC is rare, seems to be different from early and relapsed breast cancer and has not been studied as distinct disease. To achieve the objective of this study blood and tissue sample from patients diagnosed with DN-MBC will be further analyzed using next generation sequencing (NGS), in order to map the molecular/genetic characteristics of DN-MBC and to detect germline and somatic pathogenic variants. All the results will be associated with the clinicopathological characteristics of the patients.

Study Type

Observational

Enrollment (Anticipated)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Evangelia Moirogiorgou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients will be selected from community or academic or private hospitals

Description

Inclusion Criteria:

  1. Signed informed consent for the provision of the biological material for research purposes
  2. Diagnosis of de novo MBC (histologically confirmed)
  3. Age >18 years
  4. Blood samples
  5. Tumor tissue block from at least on disease site, primary (preferably) or metastatic

Exclusion Criteria:

Inadequate MBC tissue

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with de novo metastatic breast cancer
Blood and tissue sample from patients diagnosed with DN-MBC will be analyzed using next generation sequencing (NGS)
Diagnostic test: NGS in blood and Formalin-Fixed Paraffin-Embedded (FFPE) tissue
In patients with denovo metastatic breast cancer blood and tissue sample will be collected and then further analysed using NGS in order to detect somatic and germline pathogenic variants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with somatic pathogenic variants in denovo metastatic breast cancer
Time Frame: up to 12 months
up to 12 months
Number of participants with germline pathogenic variants in denovo metastatic breast cancer
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Definition of the somatic pathogenic variants measured with Next Generation Sequencing
Time Frame: up to 12 months
up to 12 months
Collection of clinicopathological characteristics of the included patients from patient's medical file
Time Frame: up to 12 months
up to 12 months
Definition of the germline pathogenic variants measured with Next Generation Sequencing
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Cooperative Oncology Group

Collaborators

Hellenic Society of Medical Oncology

Investigators

  • Principal Investigator: EVANGELIA MOIROGIORGOU, Ygeia Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 1998

Primary Completion (Actual)

October 5, 2010

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRANS_DNM_17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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