Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Baltic Countries. (AMBeR eBlood)

February 26, 2026 updated by: Pomeranian Medical University Szczecin

Introduction:

The number of diagnosed cancers is systematically increasing every year. Cancer patients need to undergo regular blood tests to monitor safety and eligibility for treatment. In case of poor blood results, the chemotherapy session must be omitted. For patients living far from the center, this means unnecessary travel with involvement of helpers, additional costs, increased potential of hospital acquired infections, and frustration associated with missed opportunity for treatment.

Aims:

The primary aim of this study is to gain knowledge about successful implementation of remote, home monitoring of complete blood count to cancer patients during and after systemic treatment for cancer. The secondary aim of the AMBeR collective study protocol is to pilot new technology, gain more context around future investigations and verify costs and changes in patient treatment pathways.

Methodology:

The investigators will test implementation of home blood monitoring in three South Baltic Countries (DK, PL, GER). Each site will participate in the implementation study with study group á n=33 (total n=165) and control group n=20 (total n=100). The duration of the study is planned for 4 cycles of chemotherapy for each patient and a 3-month follow up period. The first cycle of learning and training at the Outpatient Daily Clinic, then the remaining 3 cycles of blood monitoring at home. The average cycle length is 21-30 days, number of measurements will be determined individually depending on the diagnosis. At a baseline, after 4 cycles of chemotherapy (12-16 weeks) and after a 3-month follow-up period, parallel studies will be carried out in both the study and control groups, using mixed methods the investigators will assess outcomes of reach, effectiveness, adoption, implementation and maintenance (RE-AIM).

Expected benefits:

Implementation of the AMBeR study should reduce the amount of unnecessary and nontherapeutic hospital visits and improve manageability and independence of the patients. The investigators believe that the decrease in the number of hospital visits will diminish the risk of infection for vulnerable individuals, as well as save costs for patients and hospitals. These factors will also translate into better logistics of chemotherapy units, decreased carbon-dioxide trail, and improved quality of life and patient empowerment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Introduction:

The incidence of cancer is expected to increase by 30% over the next 20 years, mainly due to the increase in the elderly population. This will lead to a dramatic increase in the number of cancer patients in the future. Cancer patients need to undergo regular blood tests to monitor safety and eligibility for treatment. In case of poor blood results, the chemotherapy session must be omitted or modified. For patients living far from the center, this means unnecessary travel with involvement of helpers, additional costs, increased potential of hospital acquired infections, and frustration associated with missed opportunity for treatment. Digitizing cancer care can increase patients' active involvement in their own treatment, improve quality of life and reduce inequalities in access to health care. Therefore, there is a strong need to develop and implement new ways of making cancer diagnostics and treatments available to patients in their own homes.

Objective The primary aim of this study is to gain knowledge about successful implementation of remote, home monitoring of complete blood count to cancer patients during systemic treatment for cancer. The secondary aim of the AMBeR collective study protocol is to pilot new technology, gain more context around future investigations and verify costs and changes in patient treatment pathways.

Methods

Trial design This study is a multinational multisite implementation research study to pilot test implementation of home blood monitoring in 3 South Baltic countries (PL, DK, GER).

Study setting and organization The current study is part of the Interreg South Baltic Program-funded project "AMBeR" (Advanced Modelling of Baltic cancer e-caRe). A total of seven partners from five countries are involved and are working on five different WP's. The following 5 of the 7 project partners are involved in the study (WP3): 1) Zealand University Hospital Næstved, Denmark (ZUH); 2) University Medical Center Rostock, Germany (UMC Rostock); 3) University Medical Center Greifswald, Germany (UMC Greifswald); 4) University Clinical Center Gdańsk, Poland (UCC Gdańsk); 5) Pomeranian Medical University Szczecin, Poland (PMU).

Intervention The aim of this study is to evaluate the feasibility and validity of home monitoring of blood parameters during systemic treatment of cancer patients using the HemoScreen device in the patient's home. Participants will be oncology patients undergoing outpatient chemotherapy in Oncology and Hematology Departments in 5 different centers in the South Baltic region.

The investigators plan to enroll 33 patients from each center in the study group and 20 patients in the control group. Patients in the control group will undergo standard chemotherapy treatment and blood monitoring in general laboratory at the Outpatient Daily Clinic.

Patients from the study group will be instructed in the use of the HemoScreen device by trained staff and will complete self-tests throughout their first cycle of chemotherapy at the Outpatient Daily Clinic (average cycle duration 21-30 days, number of measurements determined individually depending on the diagnosis). Patients will then be given HemoScreen to use at home and will be tested immediately or up to 48 hours before their scheduled outpatient visit for chemotherapy. The results obtained will be sent to the coordinator via the IT system at least 24 hours before the planned administration of chemotherapy to determine contraindications to treatment.

If the results do not qualify for chemotherapy, depending on the center, a decision will be made to arrive to the Outpatient Daily Clinic to verify the test or to postpone the visit and issue recommendations. Each time a patient arrives at the Outpatient Day Clinic for chemotherapy, a standard venous blood test will be performed in the general laboratory. Any decision on the final administration of chemotherapy will be based on the blood count obtained from the general laboratory, not from the HemoScreen device. All trial procedures are done in addition to standard care.

The duration of the study was planned for 4 cycles of chemotherapy for each patient and a 3-month follow-up period. The first cycle of learning and training at the Outpatient Daily Clinic, then the remaining 3 cycles of blood monitoring at home. At a baseline, after 4 cycles of chemotherapy (12-16 weeks) and after a 3-month follow-up period, parallel studies will be carried out in both the study and control groups, using questionnaires (PROM's) assessing a health status and quality of life to evaluate the impact of an intervention.

Implementation

  • describing the existing care process and identifying stakeholders.
  • describing new care process, stakeholders and pathways in the new practice.
  • Workshop 1:" setting the scene" context mapping, barriers and facilitators, solution design, action plan. Participation from all relevant stakeholders identified through context mapping of the care process. A patient representative will be involved and engaged in workshop if possible, and thereby contribute with the patient perspective on barriers and facilitators.
  • Education and preparing health care professionals (HCP's) to use of the digital technology and integrating it into the "toolbox" and new professional identity.
  • Workshop 2 "facilitating/supporting the ongoing process" mid-pilot, dealing with challenges, adjusting design, planning, and supporting further implementation.
  • Workshop 3 "selecting the fruits of best practice" post-pilot, including examining learnings from the pilot trials and evaluating finalized, ongoing and planned implementation.
  • A logbook describing the process, actions, and rationale for all steps of the implementation will be used for documentation throughout the intervention phase.

Following workshop 1, pre-study identification of expected barriers and facilitators for patients to engage in remote blood monitoring at home will be carried out in 4 steps:

  • Summary from literature review and past experiences.
  • Matching the most important barriers with strategies using the ERIC matching tool.
  • Ranking strategies by effectiveness and importance in each center's clinical setting.
  • Building on strategies to develop action plans to implement interventions in each site.

Assessing RQ1: Patient's and HCP's perspectives on determinants

In the final phase of the pilot study, the investigators will examine the perspectives of patients and HCPs on important determinants of engagement in remote home blood monitoring using the Group Concept Mapping technique. The process will follow 5 pre-described steps and all activity will be online utilizing the software Groupwisdom:

  1. Brainstorming
  2. Sorting and labelling
  3. Rating
  4. Generating a cluster rating map
  5. Validation of the cluster rating map

Quantitative outcomes The investigators will use the RE-AIM framework (REF) for a systematic quantification of outcomes. A range of different outcomes, measurement methods and data sources will be used.

Data collection and management A REDCap database will be created for all study outcomes and relevant data to be collected and safely stored.

Participant and Non-participant questionnaires To obtain information about eligible patients who refuse participation in remote home blood monitoring, the investigators will invite patients to complete a short survey containing information about their characteristics, reasons for refusal, and barriers to participation. Patients who accept participation will receive a larger questionnaire reporting further on Patient Reported Outcome Measures (PROMs) and Patient Reported Experience Measures (PREMs). PROMs and PREMs will be collected using validated questionnaires. Additionally, the investigators want to examine the implementation process. To this end, a survey will be conducted at the end of the study to examine participants' and medical professionals' experiences of implementation.

Effectiveness evaluation At the baseline, after 16 weeks of treatment and 3 months of follow-up, a survey will be conducted regarding patients' perceptions of their care experience, including quality of life (PROM's - EORTC QLQ C30; EQ-5D 5L) and acceptability (Theoretical framework of Acceptability). Adherence to home blood testing and adverse events will be recorded throughout the study. At the same time, the investigators will analyze the number of unnecessary and non-therapeutic hospital visits that could potentially be avoided. Finally, health economic data will be collected to assess the economic value of the project and conduct cost-benefit analysis.

Harms and drop-outs Remote blood monitoring may be associated with adverse events and the ongoing and systematic registration of harm, drop-out and reasons for drop-out. This information will be recorded in the database on a day-to-day basis.

Economic/resource evaluation Based on the collected process data, the investigators will conduct an economic analysis assessing the time, resources and costs used for remote home monitoring. Additionally, the investigators would like to evaluate the price of the device with disposable materials, maintenance costs, time and amount of money necessary for training. Thanks to the above calculations, the investigators will try to estimate the cost-effectiveness of the change and the effective use of resources to perform blood test at home.

Sample size in pilot trials First, sample size of the pilot trial was estimated based on considerations to ensure sufficient accumulation of experience at each site to draw upon in the development of eMOC, supported by the literature on sample size recommendations for pilot and feasibility trials.

Second, the investigators defined success in the study if patients were able to use the HemoScreen equipment properly at home by following the instructions they received. Failure was defined as when the patients must call the helpline or notice that they are not using the equipment correctly at home. The investigators assumed the expected probability of success at po = 0.90. The investigators decided that if the probability of success is p=0.70 (or less), then the HemoScreen may not be useful in a given context. The null hypothesis of the study is Ho: p = p0, and the investigators wanted to test the alternative hypothesis Ha: p <p0 (one-tailed test) with a probability of 5% or less and a power of 80%. The estimated necessary sample size is N = 33 patients.

By consortium decision, each pilot study included 33 participants at each site, resulting in a total pooled sample of 165 participating patients. The consortium decided to enroll 20 control patients from each site, resulting in a total sample of 100 participants. Therefore, a total of 265 patients were planned to participate in the entire study.

Statistical methods Mainly descriptive statistics will be used to analyze quantitative outcomes, although effectiveness will be assessed with a pre-post change score.

Ethics approval and consent to participate An application for ethics approval will be submitted in each participating country, with local adaptations of this protocol.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
265

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
    • Region Sjælland
      • Næstved, Region Sjælland, Denmark, 4700
        • Recruiting
        • Department of Oncology, Zealand University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Niels Henrik Holländer, MD
        • Sub-Investigator:
          • Malene Støchkel Frank, MD, PhD
  • Germany
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
        • Recruiting
        • Clinic and Polyclinic for Internal Medicine C, Hematology and Oncology, Palliative Care Unit, University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian A Schmidt, MD, PhD, Prof
      • Rostock, Mecklenburg-Vorpommern, Germany, 18106
        • Recruiting
        • Department of Medicine, Clinic III, Hematology, Oncology, Palliative Medicine, University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Junghanß, MD, PhD, Prof
        • Sub-Investigator:
          • Moosheer Alamar, MD
  • Poland
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-952
        • Recruiting
        • Department of Oncology and Radiotherapy, University Clinical Center of Gdańsk,
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ewa Pawłowska, MD
        • Sub-Investigator:
          • Natalia Cichowska-Cwalinska, MD, PhD
        • Sub-Investigator:
          • Grażyna Suchodolska, PhD
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-252
        • Recruiting
        • Department of Hematology and Transplantology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bogusław Machaliński, MD, PhD, DSc, Prof
        • Sub-Investigator:
          • Bartłomiej Baumert, MD, PhD, DSc
        • Sub-Investigator:
          • Piotr Kulig, MD, PhD
        • Sub-Investigator:
          • Bogumiła A Osękowska, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Eligible patients are patients that suffer from cancer, require outpatient chemotherapy, and have sufficient manual skills and good eyesight to independently perform home blood monitoring, and sufficient cognitive skills to operate POCT and transfer data.

Description

Inclusion Criteria:

  • legally competent patients
  • aged 18 or older
  • diagnosed with cancer (ICD-10: C00* - C97*)
  • enrolled at the Department of Oncology/Hematology for outpatients
  • participants who are willing and able to give informed consent for participation in the study
  • participants should receive chemotherapy in Daily Chemotherapy Unit and be within 4 weeks of chemotherapy initiation, and the expected duration of chemotherapy should be at least 12 weeks from inclusion

Exclusion Criteria:

  • inability to give informed consent due to mental capacity or language barrier
  • patient unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
  • known bleeding disorder
  • bad circulation preventing the patient from getting enough blood drops to perform the test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Study group
Oncology patients undergoing home blood monitoring. n=33 per site.
Control group

Oncology patients undergoing standard blood testing in the general laboratory at the Outpatient Clinic.

n=20 per site.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient's perspectives on determinants assessed by Group Concept Mapping
Time Frame: from 4 to 12 weeks of patient participation in the intervention

Following completion or in the final phase of the pilot study, the investigators will examine the perspectives of patients on important determinants of engagement in remote home blood monitoring using the Group Concept Mapping technique. The process will follow 5 pre-described steps and all activity will be online utilizing the software Groupwisdom. The steps are as follows:

  1. Brainstorming
  2. Sorting and labelling
  3. Rating
  4. Generating a cluster rating map
  5. Validation of the cluster rating map

The investigators will invite a representative sample of patients for study.
from 4 to 12 weeks of patient participation in the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Healthcare proffessionals' perspectives on determinants assessed by Group Concept Mapping
Time Frame: between 5 patient treatments completed and end of study (on average 1 year)
Following completion or in the final phase of the pilot study, the investigators will examine the perspectives of HCPs on important determinants of engagement in remote home blood monitoring using the Group Concept Mapping technique. The process will follow 5 pre-described steps and all activity will be online utilizing the software Groupwisdom. The steps are as follows: 1) Brainstorming 2) Sorting and labelling 3) Rating 4) Generating a cluster rating map 5) Validation of the cluster rating map The investigators will invite all participating intervention delivering HCP´s to the study.
between 5 patient treatments completed and end of study (on average 1 year)
Number of referrals
Time Frame: Baseline
Number of referred patients
Baseline
Recruitment rates
Time Frame: Baseline
Number of enrolled vs. declined
Baseline
Sex of enrolled patients
Time Frame: Baseline
a) male; b) female
Baseline
Sex of decliners
Time Frame: Baseline
a) male; b) female
Baseline
Body height of enrolled patients
Time Frame: Baseline
Measured in meters
Baseline
Body height of decliners
Time Frame: Baseline
Measured in meters
Baseline
Body weight of enrolled patients
Time Frame: Baseline
Measured in kilograms
Baseline
Body weight of decliners
Time Frame: Baseline
Measured in kilograms
Baseline
Cancer disease of enrolled patients
Time Frame: Baseline
Cancer type, cancer treatment, treatment intent
Baseline
Cancer disease of decliners
Time Frame: Baseline
Cancer type, cancer treatment, treatment intent
Baseline
Educational level of enrolled patients according to International Standard Classification of Education
Time Frame: Baseline
International Standard Classification of Education (ISCED) ISCED 0 = Early childhood education ISCED 1 = Primary Education ISCED 2 = Lower Secondary Education ISCED 3 = Upper Secondary Education ISCED 4 = Post-secondary non-Tertiary Education ISCED 5 = Short-cycle tertiary education ISCED 6 = Bachelors degree or equivalent tertiary education level ISCED 7 = Masters degree or equivalent tertiary education level ISCED 8 = Doctoral degree or equivalent tertiary education level
Baseline
Educational level of decliners according to International Standard Classification of Education
Time Frame: Baseline
International Standard Classification of Education (ISCED) ISCED 0 = Early childhood education ISCED 1 = Primary Education ISCED 2 = Lower Secondary Education ISCED 3 = Upper Secondary Education ISCED 4 = Post-secondary non-Tertiary Education ISCED 5 = Short-cycle tertiary education ISCED 6 = Bachelors degree or equivalent tertiary education level ISCED 7 = Masters degree or equivalent tertiary education level ISCED 8 = Doctoral degree or equivalent tertiary education level
Baseline
Employment status of enrolled patients
Time Frame: Baseline
a) Full time, b) part time, c) self-employed, d) unemployed seeking work, e) unemployed not seeking work, f) student, g) retired, h) unable to work, i) other
Baseline
Employment status of decliners
Time Frame: Baseline
a) Full time, b) part time, c) self-employed, d) unemployed seeking work, e) unemployed not seeking work, f) student, g) retired, h) unable to work, i) other
Baseline
Distance to facility of enrolled patients
Time Frame: Baseline
Measured in km
Baseline
Distance to facility of decliners
Time Frame: Baseline
Measured in km
Baseline
Transport time to facility of enrolled patients
Time Frame: Baseline
Measured in minutes
Baseline
Transport time to facility of decliners
Time Frame: Baseline
Measured in minutes
Baseline
Health technology readiness assessed by Readiness and Enablement Index for Health Technology
Time Frame: Assessed pre-, post-intervention (16 weeks) and after 3 months of follow up
The Readiness and Enablement Index for Health Technology (READHY) instrument consists of 13 dimensions with a total of 65 items. All 13 scales reflect the conceptual dimensions and are rated on a Likert-type scale from 1=strongly disagree to 4=strongly agree
Assessed pre-, post-intervention (16 weeks) and after 3 months of follow up
European Organization of Research and Treatment in Cancer, core module (C30)
Time Frame: Assessed pre-, post-intervention (16 weeks) and after 3 months of follow up
Health Related Quality of Life tool for use in clinical trials in oncology, consisting of 30 questions, from which one can obtain points from 0 to 100. The higher the score, the lower the patient's quality of life.
Assessed pre-, post-intervention (16 weeks) and after 3 months of follow up
EuroQol-5 Dimensions-5 Levels
Time Frame: Assessed pre-, post-intervention (16 weeks) and after 3 months of follow up
EuroQol-5 Dimensions-5 Levels (EQ-5D 5L) is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire. For the EQ-5D-5L questionnaire, 3125 health states were defined: from "11111" (no problems at all) to "55555" ("extreme problems" in all five domains)
Assessed pre-, post-intervention (16 weeks) and after 3 months of follow up
Attendance rate
Time Frame: Assessed post-intervention (16 weeks)
Number of home blood tests performed versus number of tests ordered
Assessed post-intervention (16 weeks)
Adverse events during home blood testing
Time Frame: Assessed post-intervention (16 weeks)
Registration of all adverse events throughout the intervention
Assessed post-intervention (16 weeks)
Acceptability for patients assessed using the Theoretical Framework of Acceptability Questionnaire
Time Frame: Assessed post-intervention (16 weeks)
Theoretical Framework of Acceptability (TFA) Questionnaire is used to assess operational problems and failure rates in terms of technology and language. It consists of 8 questions that can be answered on a scale of difficulty in using technology or understanding the language from 1 (min.) to 5 (max.).
Assessed post-intervention (16 weeks)
Acceptability for healthcare professionals assessed using the Theoretical Framework of Acceptability Questionnaire
Time Frame: Assessed post-intervention (16 weeks)
Theoretical Framework of Acceptability (TFA) Questionnaire is used to assess operational problems and failure rates in terms of technology and language. It consists of 8 questions that can be answered on a scale of difficulty in using technology or understanding the language from 1 (min.) to 5 (max.).
Assessed post-intervention (16 weeks)
Administrative time consumption per patient
Time Frame: Assessed post-intervention (16 weeks)
Measured in minutes and number of contact attempts
Assessed post-intervention (16 weeks)
Medical time consumption per patient
Time Frame: Assessed post-intervention (16 weeks)
Measured in minutes
Assessed post-intervention (16 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pomeranian Medical University Szczecin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zealand University Hospital
University Medicine Greifswald
University Clinical Centre, Gdansk
University Medical Center Rostock

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bogusław Machaliński, MD, PhD, Prof, Department of Hematology and Transplantology, Pomeranian Medical University in Szczecin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • p-2024-17504
  • STHB.01.01-IP.01-0005/23 (Other Grant/Funding Number: Interreg South Baltic 2021-2027 programme)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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