Breast Cancer-specific SurvivalNCT04798976
Personalized Evidence-based Treatment in Patients With Invasive Breast Cancer
An observational study of Breast Cancer-specific Survival, run by Center of Personalized Medicine, Pirogova at 1 site in Russia.
Trial summary
A population-based case-cohort study of breast cancer-specific survival among all first invasive breast cancer cases Read more about this study
- Who is it for?
- Ages Up to 70 years, women only
- Conditions the study is for
- Breast Cancer-specific Survival
- What is being tested?
- neoadjuvant/adjuvant therapy
- How many people
- 3,000 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2021to 30 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All first invasive breast cancer cases from a National Cancer Registry
Who may be able to join
- All women with stage I-III disease who survived at least 12 months post-diagnosis
Who cannot join
- Unknown cause of death Treatment outside the region (thus precluding the treatment assessment)
Trial locations and contacts
1 site in 1 country.
Irina Ostanina, MD contact
Russia1 site, 1 recruiting
- Recruiting
Evgeny Pokushalov
Novosibirsk, 630090
Evgeny Pokushalov, Prof. MD PhD, 89139254858, e.pokushalov@gmail.com
About this study
Official title: 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
- Conditions
- Breast Cancer-specific Survival
- Being tested
- neoadjuvant/adjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant/adjuvant therapyDrug
chemotherapy/endocrine therapy/surgery/radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| CDSS (MedicBK) Analysis | Not described Receives: Drug: neoadjuvant/adjuvant therapy | |
| Core Laboratory Analysis | Not described Receives: Drug: neoadjuvant/adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-year
Secondary outcomes (3)
Breast cancer-specific survival
All deaths due to breast cancer-related causes
Measured: 3-year
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
Measured: 3-year
Predictors
Predictors of guideline-consistent and personalized EBM adherence
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Mar 2021
- Primary completion1 May 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer-specific SurvivalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center of Personalized Medicine, Pirogova
- Sponsor type
- University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia, I.M. Sechenov First Moscow State Medical University
- Responsible party
- Principal investigator, Evgeny Pokushalov, Center of Personalized Medicine, Pirogova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798976
- Sponsor's protocol ID
- 20210312
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Evidence-based Treatment Improves Survival in Patients With Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT04798976
- Acronym / sponsor ID
- 20210312
- Conditions
- Breast Cancer-specific Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Center of Personalized Medicine, PirogovaUniversity, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia, I.M. Sechenov First Moscow State Medical University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A population-based case-cohort study of breast cancer-specific survival among all first invasive breast cancer cases
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDSS (MedicBK) Analysis | – | Drug: neoadjuvant/adjuvant therapy |
| Core Laboratory Analysis | – | Drug: neoadjuvant/adjuvant therapy |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All first invasive breast cancer cases from a National Cancer Registry
Key inclusion criteria (1 listed)
- All women with stage I-III disease who survived at least 12 months post-diagnosis
Key exclusion criteria (1 listed)
- Unknown cause of death Treatment outside the region (thus precluding the treatment assessment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant/adjuvant therapychemotherapy/endocrine therapy/surgery/radiotherapy | Drug | CDSS (MedicBK) Analysis, Core Laboratory Analysis |
Primary outcome
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 secondary outcomes
Breast cancer-specific survival
Time frame: 3-year
Quantify the performance of the CDSS (MedicBK) algorithm
Time frame: 3-year
Predictors
Time frame: 3-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer-specific Survival
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irina Ostanina, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer-specific Survival, run by Center of Personalized Medicine, Pirogova at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Pokushalov, Prof. MD PhD (89139254858, e.pokushalov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of guideline-consistent and personalized EBM recommendations (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.