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Personalized Evidence-based Treatment in Patients With Invasive Breast Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04798976
Enrollment
3000
Registered
2021-03-16
Start date
2021-03-01
Completion date
2021-05-30
Last updated
2021-03-16

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

Conditions

Breast Cancer-specific Survival

Brief summary

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

Interventions

DRUGneoadjuvant/adjuvant therapy

chemotherapy/endocrine therapy/surgery/radiotherapy

Sponsors

Center for New Medical Technologies, Novosibirsk, Russia
CollaboratorOTHER
I.M. Sechenov First Moscow State Medical University
CollaboratorOTHER
Center of Personalized Medicine, Pirogova
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The percentage of guideline-consistent and personalized EBM recommendations3-yearThe 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.

Secondary

MeasureTime frameDescription
Breast cancer-specific survival3-yearAll deaths due to breast cancer-related causes
Quantify the performance of the CDSS (MedicBK) algorithm3-yearQuantify 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
Predictors3-yearPredictors of guideline-consistent and personalized EBM adherence

Countries

Russia

Contacts

Primary ContactEvgeny Pokushalov, Prof. MD PhD
e.pokushalov@gmail.com89139254858
Backup ContactIrina Ostanina, MD
+79039031563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026