NCT04798976

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 11, 2021

Last Update Submit

March 11, 2021

Conditions

Breast Cancer-specific Survival

Outcome Measures

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.

    3-year

Secondary Outcomes (3)

  • Breast cancer-specific survival

    3-year

  • Quantify the performance of the CDSS (MedicBK) algorithm

    3-year

  • Predictors

    3-year

Study Arms (2)

CDSS (MedicBK) Analysis

Drug: neoadjuvant/adjuvant therapy

Core Laboratory Analysis

Drug: neoadjuvant/adjuvant therapy

Interventions

neoadjuvant/adjuvant therapyDRUG

chemotherapy/endocrine therapy/surgery/radiotherapy

CDSS (MedicBK) AnalysisCore Laboratory Analysis

Eligibility Criteria

AgeUp to 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All first invasive breast cancer cases from a National Cancer Registry

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evgeny Pokushalov

Novosibirsk, 630090, Russia

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Central Study Contacts

Evgeny Pokushalov, Prof. MD PhD

CONTACT

89139254858e.pokushalov@gmail.com

Irina Ostanina, MD

CONTACT

+79039031563

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director for research and development

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 16, 2021

Study Start

March 1, 2021

Primary Completion

May 1, 2021

Study Completion

May 30, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

RU(1)