Breast Cancer-specific Survival Clinical Trial
Official title:
Personalized Evidence-based Treatment Improves Survival in Patients With Invasive Breast Cancer
| NCT number | NCT04798976 |
| Other study ID # | 20210312 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 1, 2021 |
| Est. completion date | May 30, 2021 |
A population-based case-cohort study of breast cancer-specific survival among all first invasive breast cancer cases
| Status | Recruiting |
| Enrollment | 3000 |
| Est. completion date | May 30, 2021 |
| Est. primary completion date | May 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A to 70 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Evgeny Pokushalov | Novosibirsk |
| Lead Sponsor | Collaborator |
|---|---|
| Center of Personalized Medicine, Pirogova | Center for New Medical Technologies, Novosibirsk, Russia., I.M. Sechenov First Moscow State Medical University |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Breast cancer-specific survival | All deaths due to breast cancer-related causes | 3-year | |
| Secondary | 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 | 3-year | |
| Secondary | Predictors | Predictors of guideline-consistent and personalized EBM adherence | 3-year |