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Status unknownNCT04798976Updated Mar 16, 2021

Personalized Evidence-based Treatment in Patients With Invasive Breast Cancer

An observational study in Breast Cancer-specific Survival, sponsored by Center of Personalized Medicine, Pirogova. Status unknown at 1 site in Russian Federation. Open to female participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-16.

Sponsored by Center of Personalized Medicine, Pirogova · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,000
Ages
Up to 70 Years
Sex
Female
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Study summary

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

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Conditions studied

  • Breast Cancer-specific Survival

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Center of Personalized Medicine, Pirogova is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All first invasive breast cancer cases from a National Cancer Registry

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • CDSS (MedicBK) Analysis

    Drug: neoadjuvant/adjuvant therapy

  • Core Laboratory Analysis

    Drug: neoadjuvant/adjuvant therapy

Interventions

  • Drugneoadjuvant/adjuvant therapy

    chemotherapy/endocrine therapy/surgery/radiotherapy

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What researchers measure

Primary outcomes

  1. The percentage of guideline-consistent and personalized EBM recommendations

    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.

    Time frame: 3-year

Secondary outcomes

  1. Breast cancer-specific survival

    All deaths due to breast cancer-related causes

    Time frame: 3-year

  2. Quantify the performance of the CDSS (MedicBK) algorithm

    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

    Time frame: 3-year

  3. Predictors

    Predictors of guideline-consistent and personalized EBM adherence

    Time frame: 3-year

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Study locations

1 of 1 sites recruiting
  • Evgeny Pokushalov
    Novosibirsk, 630090, Russian Federation
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04798976
Lead sponsor
Center of Personalized Medicine, Pirogova
Collaborators
Center for New Medical Technologies, Novosibirsk, Russia, I.M. Sechenov First Moscow State Medical University
Responsible party
Evgeny Pokushalov (Director for research and development, Center of Personalized Medicine, Pirogova) — Principal investigator
First posted
Mar 16, 2021
Start date
Mar 1, 2021
Primary completion
May 1, 2021 (estimated)
Completion
May 30, 2021 (estimated)
Last update
Mar 16, 2021

Study contacts

Evgeny Pokushalov, Prof. MD PhD
Contact
e.pokushalov@gmail.com
89139254858
Irina Ostanina, MD
Contact
+79039031563

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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