Personalized Evidence-based Treatment in Patients With Invasive Breast Cancer

March 11, 2021 updated by: Evgeny Pokushalov, Center of Personalized Medicine, Pirogova

Personalized Evidence-based Treatment Improves Survival in Patients With Invasive Breast Cancer

A population-based case-cohort study of breast cancer-specific survival among all first invasive breast cancer cases

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

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

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

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All first invasive breast cancer cases from a National Cancer Registry

Description

Inclusion Criteria:

All women with stage I-III disease who survived at least 12 months post-diagnosis

Exclusion Criteria:

Unknown cause of death Treatment outside the region (thus precluding the treatment assessment)

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
CDSS (MedicBK) Analysis
Drug: neoadjuvant/adjuvant therapy
chemotherapy/endocrine therapy/surgery/radiotherapy
Core Laboratory Analysis
Drug: neoadjuvant/adjuvant therapy
chemotherapy/endocrine therapy/surgery/radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of guideline-consistent and personalized EBM recommendations
Time Frame: 3-year
The percentage of guideline-consistent and personalized EBM recommendations acted on by clinicians in patients with first invasive breast cancer. All discrepancies between routine and CDSS-recommended treatment resulting in frame of guideline-consistent therapy and personalized EBM therapy will be adjudicated by core laboratory.
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantify the performance of the CDSS (MedicBK) algorithm
Time Frame: 3-year
Quantify the performance of the CDSS (MedicBK) algorithm for presents treatment suggestions in frame of guideline-based therapy and personalized EBM therapy: the sensitivity, specificity, NPV, and PPV
3-year
Breast cancer-specific survival
Time Frame: 3-year
All deaths due to breast cancer-related causes
3-year
Predictors
Time Frame: 3-year
Predictors of guideline-consistent and personalized EBM adherence
3-year

Collaborators and Investigators

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

Sponsor

Center of Personalized Medicine, Pirogova

Collaborators

I.M. Sechenov First Moscow State Medical University
Center for New Medical Technologies, Novosibirsk, Russia

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)

March 1, 2021

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 30, 2021

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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