Decision Support Systems, ClinicalNCT04802941
Neoadjuvant Chemotherapy in Breast Cancer
A study testing Neoadjuvant Chemotherapy by CDSS (MedicBK) and General practice in people with Decision Support Systems, Clinical, run by Center of Personalized Medicine, Pirogova at 1 site in Russia.
Trial summary
This study compares two approaches of upfront chemotherapy in breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decision Support Systems, Clinical
- What is being tested?
- Neoadjuvant Chemotherapy by CDSS (MedicBK) and General practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteRussia
- Study dates
- 12 Mar 2021to 30 Mar 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed infiltrating breast cancer
- Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.
- Age ≥18
- Eastern Cooperative Oncology Group performance status ≤1
- Adequate bone marrow function (ANC >1.5 x 109/l, platelets >100 x 109/l)
- Adequate hepatic function (ALAT, ASAT and bilirubin <2.5 times upper limit of normal)
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- Adequate renal function (creatinine clearance >50 ml/min)
- LVEF ≥50% measured by echocardiography or MUGA
- Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Absence of any medical condition that would place the patient at unusual risk.
- Signed written informed consent
Who cannot join
- previous radiation therapy or chemotherapy
- other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
- current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection
- evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures.
- evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast.
- concurrent anti-cancer treatment or another investigational drug.
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: Optimizing Neoadjuvant Systemic Treatment for Breast Cancer by Clinical Decision Support System
This study compares two approaches of upfront chemotherapy in breast cancer.
Read the detailed description
A Decision Support System (DSS) is an information system that supports business, medical, educational or organisational decision-making activities. DSSs fuse human knowledge and technology to support and improve decision-making.
The area of precision oncology that supports the treatment of breast cancer has not only seen an increase in the availability of different treatment choices but also genomic tools to support the decision-making process. CDSSs have been available for use in clinical oncology practice for over a decade. However, there has been some criticism around the utility of CDSS in personalised medicine decision-making of breast cancer, with these systems often viewed as aids better suited to support the 'average' patient's requirements rather than personalised treatment for the individual patient.
The purpose of the current study is to evaluate an innovative CDSS (MedicBK) platform based on the comparison of multiple treatments simultaneously in making care decisions taking into account the individual characteristics of patients, i.e., based on personalized evidence-based medicine.
- Conditions
- Decision Support Systems, Clinical
- Being tested
- Neoadjuvant Chemotherapy by CDSS (MedicBK), General practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Chemotherapy by CDSS (MedicBK)Device
CDSS (MedicBK) captures the patient-specific data required to determine appropriate care decisions from the EMR and then presents relevant data alongside treatment suggestions to clinicians. MedicBK uses algorithms for presenting treatment suggestions framed by guideline-based therapy and personalized personalized evidence-based therapy. MedicBK consists of three main blocks: database, network meta-analysis, and heterogeneity of treatment effects assessment.
General practiceDrug
General practice
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemotherapy by CDSS | Experimental | Not described Receives: Device: Neoadjuvant Chemotherapy by CDSS (MedicBK) |
| Neoadjuvant Chemotherapy in General practice | Active comparator | Not described Receives: Drug: General practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with pathological complete response
To compare the efficacy of Neoadjuvant Chemotherapy in general practice and by CDSS
Measured: at week 30
Secondary outcomes (2)
Number of patients with grade >2 adverse events as a measure of safety and tolerability
to describe the safety of the various regimens toxicity is compared between the two arms
Measured: up to week 35
identify prognostic and predictive for pathological complete response
To identify prognostic and predictive for pathological complete response after neoadjuvant treatment
Measured: within one year after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start12 Mar 2021
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision Support Systems, ClinicalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 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, Novosibirsk Oncology Center
- Responsible party
- Principal investigator, Evgeny Pokushalov, Center of Personalized Medicine, Pirogova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802941
- Sponsor's protocol ID
- 20210312/2
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 18 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 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Neoadjuvant Systemic Treatment for Breast Cancer by Clinical Decision Support System
- ClinicalTrials.gov ID
- NCT04802941
- Acronym / sponsor ID
- 20210312/2
- Conditions
- Decision Support Systems, Clinical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 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, Novosibirsk Oncology Center
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 17 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.
This study compares two approaches of upfront chemotherapy in breast cancer.
Detailed description
A Decision Support System (DSS) is an information system that supports business, medical, educational or organisational decision-making activities. DSSs fuse human knowledge and technology to support and improve decision-making.
The area of precision oncology that supports the treatment of breast cancer has not only seen an increase in the availability of different treatment choices but also genomic tools to support the decision-making process. CDSSs have been available for use in clinical oncology practice for over a decade. However, there has been some criticism around the utility of CDSS in personalised medicine decision-making of breast cancer, with these systems often viewed as aids better suited to support the 'average' patient's requirements rather than personalised treatment for the individual patient.
The purpose of the current study is to evaluate an innovative CDSS (MedicBK) platform based on the comparison of multiple treatments simultaneously in making care decisions taking into account the individual characteristics of patients, i.e., based on personalized evidence-based medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemotherapy by CDSS | Experimental | Device: Neoadjuvant Chemotherapy by CDSS (MedicBK) |
| Neoadjuvant Chemotherapy in General practice | Active comparator | Drug: General practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed infiltrating breast cancer
- Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.
- Age ≥18
- Eastern Cooperative Oncology Group performance status ≤1
- Adequate bone marrow function (ANC >1.5 x 109/l, platelets >100 x 109/l)
Key exclusion criteria (6 listed)
- previous radiation therapy or chemotherapy
- other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
- current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection
- evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures.
- evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast.
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 Chemotherapy by CDSS (MedicBK)CDSS (MedicBK) captures the patient-specific data required to determine appropriate care decisions from the EMR and then presents relevant data alongside treatment suggestions to clinicians. MedicBK uses algorithms for presenting treatment suggestions framed by guideline-based therapy and personalized personalized evidence-based therapy. MedicBK consists of three main blocks: database, network meta-analysis, and heterogeneity of treatment effects assessment. | Device | Neoadjuvant Chemotherapy by CDSS |
| General practiceGeneral practice | Drug | Neoadjuvant Chemotherapy in General practice |
Primary outcome
Number of patients with pathological complete response
Time frame: at week 30
To compare the efficacy of Neoadjuvant Chemotherapy in general practice and by CDSS
2 secondary outcomes
Number of patients with grade >2 adverse events as a measure of safety and tolerability
Time frame: up to week 35
identify prognostic and predictive for pathological complete response
Time frame: within one year after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Neoadjuvant Chemotherapy by CDSS (MedicBK) and General practice in people with Decision Support Systems, Clinical, 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 11 inclusion and 6 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 18 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?
Number of patients with pathological complete response (time frame: at week 30). 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 18 Mar 2021.