Breast CancerLC_RLPNCT05797727
Real-Life Pilot Feasibility Study (LC_RLP)
A study testing LifeChamps Platform HCP and LifeChamps Platform in people with Breast Cancer and Prostate Cancer, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The LifeChamps Real-Life pilot's objective is to ascertain the feasibility of the use of the LifeChamps solution, previously developed in another clinical trial, in a real-world environment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- What is being tested?
- LifeChamps Platform HCP and LifeChamps Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jan 2023to 6 Dec 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Breast or prostate cancer.
- Diagnosed with early stage (I-III) cancer (breast, prostate) and living beyond initial cancer treatment (curative/incurable).
- Diagnosed with advanced or metastatic disease with life expectancy >12 months.
- At least 1 month after a) local treatment with curative intent (surgery, radiotherapy) or b) initiation of systemic treatment (hormone treatment, CDK4/6 or new generation antiandrogens).
- Absence of diagnosed secondary malignancy.
- Deemed by a member of the multidisciplinary team as physically and psychologically fit to participate in the study.
Show all 10Show fewer
- Able to read, write and understand the respective local language (greek).
- Achieve a score of above 2 on the Mini-Cog during the screening process.
- Able to bring and use own Android version 10 (or above) device during the study.
- Domestic 24/7 internet access via wi-fi and/or 4G mobile data (will be provided if unavailable).
Who cannot join
- Currently receiving chemotherapy.
- Terminal cancer stage on palliative care.
- Survival prognosis of <18 months from the time of recruitment.
- Unwilling to provide written informed consent.
- Presence of internal medical device (e.g. pacemaker etc.)
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Medical Physics and Digital Innovation, AUTH
Thessaloniki, 54636
About this study
Official title: LIFECHAMPS: A Collective Intelligence Platform to Support Cancer Champions Real-Life Pilot
The LifeChamps Real-Life pilot's objective is to ascertain the feasibility of the use of the LifeChamps solution, previously developed in another clinical trial, in a real-world environment. This solution integrates a health advisory system, and technical intelligence, based on behavioural science, to provide personalized recommendations to follow a healthier lifestyle, to act as a nutrition and physical activity coach, and to guide on social inclusion, among other issues, with the aim of increasing the quality of life. This study is conducted to investigate the feasibility of such an undertaking, assess the clinical impact it may have, as well as evaluate the applicability, usability, and effectiveness of the solution.
Read the detailed description
"The LifeChamps project (https://lifechamps.eu/) is creating a digital platform to support clinical teams to provide more integrated follow-up care to older patients with cancer. The digital platform will integrate data coming directly from the patient (patient-reported outcomes and sensor data from wearable devices), from the home environment (home sensors, weight scales), and from the clinical environment (data routinely collected via the Electronic Health Record). The digital platform will use big data analytics (machine learning) to process all data as part of predictive clinical algorithms for frailty and quality of life for older patients with cancer. Development of each clinical algorithm requires that the prototype model (or analytics engine) is trained using abundant real-world data to help consolidate the predictive ability and validity of the algorithms before the algorithms are deployed in a larger scale feasibility trial.
A pre-post design will be employed, whereby the LifeChamps platform will be deployed for a total of 3 months.
The main research questions of the study are:
- Is patient recruitment possible in terms of numbers and rates within the recruitment period?
- Is participant retention in the study possible in terms of numbers and rates?
- Do participants adhere to the protocol?
- What are the views/experiences of study participants (patients and healthcare professionals) using the Lifechamps solution (mHealth app and dashboard respectively)?
- What is the adherence with the usage of the different digital health patients' tools (e.g., usage of mHealth app, smartwatch, smart weight scale)?
Healthcare professionals related to oncology (oncologists, nurses etc.) will also be recruited to use the LifeChamps dashboard and evaluate its usefulness, usability and acceptability. They will have access to and asked to use the LC Dashboard. The LC Dashboard will provide pseudonymised information regarding the patients' physical activity and PROMs for the purpose of the pilot feasibility trial. They will not be able to view real time processed information. After the patients have exited the study, the HCPs will be shown the anonymised outputs of the engine per patient and asked their opinions.
Older patients with a cancer diagnosis will be the target population for this study. Target number of participants is 200. Each study participant will be involved in the study for 3 months in total. A 4-month recruitment period will be allowed, bringing the total study duration to 7 months (from first patient being enrolled until last patient finishing data collection).
After written informed consent has been provided, the mini-COG will be used to evaluate study participants' cognitive function and impairment at baseline. The mini-COG consists of a 3-word recall and a clock-drawing test, and can be completed within 5 minutes. A score of less than 3/5 indicates the need to refer the patient for full cognitive assessment. Study endpoints will be collected at this point.
The researcher will also arrange for study participants to receive study equipment, i.e. home sensors, wearable activity sensors, smart weight scale, and mobile app. The researcher will arrange a suitable time for a home visit to install the home sensors and test functionality. The researcher will demonstrate use of study equipment to the participant, and reiterate that support with use of the technology will be available.
Data collection will involve a variety of sources, including the patient (patient-reported outcomes and sensor data from wearable devices), the home environment (home sensors, weight scales), and the clinical site (data routinely collected via the Electronic Health Record).
The following technology will be used:
Mobile devices:
Activity tracker wristband (FitBit charge 4). It will be used to passively monitor and collect data on heart rate, heart rate variability, steps, activity tracking, sleep monitoring, breathing rate, skin temperature and SpO2.
mHealth app (SALUMEDIA). It will be used to enable collection of patient-reported outcome measures (PROMs) and to forward this information along with the data gathered by the activity tracker and the smart scale to the Raspberry Pi Kit at home.
At home sensors / devices:
LOCS Home sensors: They will be used to monitor participants' daily activities e.g., to track ambulation and functioning. Study participants will be provided with 4 motion sensors, 1 door contact sensor, 2 corridor sensors, and a tag device.
Smart Scale (Withings Body+): It will be used to measure weekly body weight, body composition and body mass index.
Raspberry Pi (RPI) kit: As an edge gateway, RPI is hosting LOCS gateway, Movesense Gateway and data ingestion service. RPI will enable data collection and edge analytics and transfer of data to the LIFECHAMPS platform.
Smart plug: It will be used to collect data about use home appliances and thereby data about active daily living.
Selected study participant clinical and demographic data from the local EHRs will be collected and loaded onto the LifeChamps analytics engine. The data will be loaded by technical partners via the LifeChamps dashboard for processing and analysis. Data regarding recruitment rate (patients consenting / patients approached), participant retention in the study, reasons for study discontinuation (if offered), participant adherence with technology, issues with technology and need for troubleshooting will be recorded. These data will (a) be recorded by local researchers using bespoke 'recording logs' in the form of an Excel spreadsheet, and (b) remotely monitored and logged by technical partners involved in the distribution / management of the technology to be used in the trial as described above."
- Conditions
- Breast Cancer, Prostate Cancer
- Being tested
- LifeChamps Platform HCP, LifeChamps Platform
- Keywords
- Cancer, mHealth App, Ambient Sensors, Wearables, Smartwatch, Smart scale, Analytics Engine
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeChamps Platform HCPDevice
Healthcare professionals that will participate in the study will be introduced will have access to the LifeChamps Dashboard, which will display the data monitored from the patients, thus potentially facilitating patients' follow-up between clinical consultations. The LC Dashboard will provide pseudonymised information regarding the patients' physical activity and PROMs for the purpose of the pilot feasibility trial. They will not be able to view real time processed information, such as risk of frailty, QoL, risk of dependency and psychological condition, from the LIFECHAMPS analytics engine. They will be shown the anonymised outputs of the engine per patient and asked their opinions on the usability, acceptability and on whether such information would have helped better manage their patients' supportive care.
LifeChamps PlatformDevice
Participants will be asked to provide 5 endpoints (PROMS) and will be provided with the study equipment, i.e., a mobile app, smartwatch, smart scale, location home sensor, a smart plug, and a micro-computer, with which they will need to interact with the devices for three months. Specifically, participants should wear the activity tracker wristband (Fitbit Charge 4) as much as possible. Additionally, participants should use the smart scale to weigh themselves and the mobile app to fill in selected PROMs monthly, while the ambient home sensors will be passively collecting information about their everyday living during these three months. At the end of the 3 month period, the participants will return the devices and will be asked to provide the 5 endpoints and their opinions regarding the usability and acceptability of the platform using structured questionnaires
| Study group | Role | What they receive |
|---|---|---|
| LifeChamps Platform | Experimental | Participants will be asked to use the LifeChamps platform and will be provided with the study equipment. Receives: Device: LifeChamps Platform |
| LifeChamps Platform HCP | Experimental | Participating Healthcare professionals will be asked to use the LifeChamps Dashboard Receives: Device: LifeChamps Platform HCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
This outcome will be calculated by dividing the number of participants consented over the number of approached participants. It is a ratio between 0 and 1, with 1 being the best outcome.
Measured: 7 months
Participant retention rate
This outcome will be calculated by dividing the number of participants that finished the study over the number of participants that entered the study. It is a ratio between 0 and 1, with 1 being the best outcome.
Measured: 7 months
Technology Adherence rate
This outcome will be calculated by dividing the number of times the technology was used over the maximum times that technology can be used over the course of the study. It is a ratio between 0 and 1, with 1 being the best outcome.
Measured: 7 months
Secondary outcomes (4)
Quality of life Assessment
This outcome will be measured using the EQ-5D-5L questionnaire. It is using 5-Level Likert scale, with 0 being the best. Also, it includes a self-report of health status using a 0 to 100 scale, 100 being best.
Measured: 3 months
Functional Assessment
This outcome will be measured using the Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) Questionnaire. It uses a 5-Level Likert scale, 0 being the best.
Measured: 3 months
Frailty
This outcome will be measured using the Tilburg Frailty Indicator. It uses Yes-No questions to calculate a score between 0 and 15, with 0 being the best.
Measured: 3 months
Quality of Life Utility Measure
This outcome will be measured using the EORTC QUALITY OF LIFE UTILITY - CORE 10 DIMENSIONS (QLU-C10D) Questionnaire. It uses a 4-Level Likert scale, with 4 being the best.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start15 Jan 2023
- Primary completion30 Nov 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel: Clinical trials with a two arms: A prospective, pre-post design will be employed, whereby the LifeChamps platform will be deployed for a total of 3 months
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Region Stockholm, Hospital Universitario La Fe
- Responsible party
- Principal investigator, Panos Bamidis, Aristotle University Of Thessaloniki
- Investigators
- Panos D Bamidis, PhD, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797727
- Sponsor's protocol ID
- 875329B
- Acronym
- LC_RLP
- Status last verified
- Feb 2024
- First submitted
- 22 Mar 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected during the Real-Life pilot study, will be made available for sharing via open access repositories, according to the Final Version of the Data Managements Plan of the project.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFECHAMPS: A Collective Intelligence Platform to Support Cancer Champions Real-Life Pilot
- ClinicalTrials.gov ID
- NCT05797727
- Acronym / sponsor ID
- LC_RLP / 875329B
- Conditions
- Breast Cancer, Prostate Cancer
- Keywords
- Cancer, mHealth App, Ambient Sensors, Wearables, Smartwatch, Smart scale, Analytics Engine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- University of Glasgow, Region Stockholm, Hospital Universitario La Fe
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 4 Apr 2023 (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.
The LifeChamps Real-Life pilot's objective is to ascertain the feasibility of the use of the LifeChamps solution, previously developed in another clinical trial, in a real-world environment. This solution integrates a health advisory system, and technical intelligence, based on behavioural science, to provide personalized recommendations to follow a healthier lifestyle, to act as a nutrition and physical activity coach, and to guide on social inclusion, among other issues, with the aim of increasing the quality of life. This study is conducted to investigate the feasibility of such an undertaking, assess the clinical impact it may have, as well as evaluate the applicability, usability, and effectiveness of the solution.
Detailed description
"The LifeChamps project (https://lifechamps.eu/) is creating a digital platform to support clinical teams to provide more integrated follow-up care to older patients with cancer. The digital platform will integrate data coming directly from the patient (patient-reported outcomes and sensor data from wearable devices), from the home environment (home sensors, weight scales), and from the clinical environment (data routinely collected via the Electronic Health Record). The digital platform will use big data analytics (machine learning) to process all data as part of predictive clinical algorithms for frailty and quality of life for older patients with cancer. Development of each clinical algorithm requires that the prototype model (or analytics engine) is trained using abundant real-world data to help consolidate the predictive ability and validity of the algorithms before the algorithms are deployed in a larger scale feasibility trial.
A pre-post design will be employed, whereby the LifeChamps platform will be deployed for a total of 3 months.
The main research questions of the study are:
- Is patient recruitment possible in terms of numbers and rates within the recruitment period?
- Is participant retention in the study possible in terms of numbers and rates?
- Do participants adhere to the protocol?
- What are the views/experiences of study participants (patients and healthcare professionals) using the Lifechamps solution (mHealth app and dashboard respectively)?
- What is the adherence with the usage of the different digital health patients' tools (e.g., usage of mHealth app, smartwatch, smart weight scale)?
Healthcare professionals related to oncology (oncologists, nurses etc.) will also be recruited to use the LifeChamps dashboard and evaluate its usefulness, usability and acceptability. They will have access to and asked to use the LC Dashboard. The LC Dashboard will provide pseudonymised information regarding the patients' physical activity and PROMs for the purpose of the pilot feasibility trial. They will not be able to view real time processed information. After the patients have exited the study, the HCPs will be shown the anonymised outputs of the engine per patient and asked their opinions.
Older patients with a cancer diagnosis will be the target population for this study. Target number of participants is 200. Each study participant will be involved in the study for 3 months in total. A 4-month recruitment period will be allowed, bringing the total study duration to 7 months (from first patient being enrolled until last patient finishing data collection).
After written informed consent has been provided, the mini-COG will be used to evaluate study participants' cognitive function and impairment at baseline. The mini-COG consists of a 3-word recall and a clock-drawing test, and can be completed within 5 minutes. A score of less than 3/5 indicates the need to refer the patient for full cognitive assessment. Study endpoints will be collected at this point.
The researcher will also arrange for study participants to receive study equipment, i.e. home sensors, wearable activity sensors, smart weight scale, and mobile app. The researcher will arrange a suitable time for a home visit to install the home sensors and test functionality. The researcher will demonstrate use of study equipment to the participant, and reiterate that support with use of the technology will be available.
Data collection will involve a variety of sources, including the patient (patient-reported outcomes and sensor data from wearable devices), the home environment (home sensors, weight scales), and the clinical site (data routinely collected via the Electronic Health Record).
The following technology will be used:
Mobile devices:
Activity tracker wristband (FitBit charge 4). It will be used to passively monitor and collect data on heart rate, heart rate variability, steps, activity tracking, sleep monitoring, breathing rate, skin temperature and SpO2.
mHealth app (SALUMEDIA). It will be used to enable collection of patient-reported outcome measures (PROMs) and to forward this information along with the data gathered by the activity tracker and the smart scale to the Raspberry Pi Kit at home.
At home sensors / devices:
LOCS Home sensors: They will be used to monitor participants' daily activities e.g., to track ambulation and functioning. Study participants will be provided with 4 motion sensors, 1 door contact sensor, 2 corridor sensors, and a tag device.
Smart Scale (Withings Body+): It will be used to measure weekly body weight, body composition and body mass index.
Raspberry Pi (RPI) kit: As an edge gateway, RPI is hosting LOCS gateway, Movesense Gateway and data ingestion service. RPI will enable data collection and edge analytics and transfer of data to the LIFECHAMPS platform.
Smart plug: It will be used to collect data about use home appliances and thereby data about active daily living.
Selected study participant clinical and demographic data from the local EHRs will be collected and loaded onto the LifeChamps analytics engine. The data will be loaded by technical partners via the LifeChamps dashboard for processing and analysis. Data regarding recruitment rate (patients consenting / patients approached), participant retention in the study, reasons for study discontinuation (if offered), participant adherence with technology, issues with technology and need for troubleshooting will be recorded. These data will (a) be recorded by local researchers using bespoke 'recording logs' in the form of an Excel spreadsheet, and (b) remotely monitored and logged by technical partners involved in the distribution / management of the technology to be used in the trial as described above."
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel: Clinical trials with a two arms: A prospective, pre-post design will be employed, whereby the LifeChamps platform will be deployed for a total of 3 months
| Arm | Type | Receives |
|---|---|---|
| LifeChamps Platform | Experimental | Device: LifeChamps PlatformParticipants will be asked to use the LifeChamps platform and will be provided with the study equipment. |
| LifeChamps Platform HCP | Experimental | Device: LifeChamps Platform HCPParticipating Healthcare professionals will be asked to use the LifeChamps Dashboard |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Breast or prostate cancer.
- Diagnosed with early stage (I-III) cancer (breast, prostate) and living beyond initial cancer treatment (curative/incurable).
- Diagnosed with advanced or metastatic disease with life expectancy >12 months.
- At least 1 month after a) local treatment with curative intent (surgery, radiotherapy) or b) initiation of systemic treatment (hormone treatment, CDK4/6 or new generation antiandrogens).
- Absence of diagnosed secondary malignancy.
Key exclusion criteria (5 listed)
- Currently receiving chemotherapy.
- Terminal cancer stage on palliative care.
- Survival prognosis of <18 months from the time of recruitment.
- Unwilling to provide written informed consent.
- Presence of internal medical device (e.g. pacemaker etc.)
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 |
|---|---|---|
| LifeChamps Platform HCPHealthcare professionals that will participate in the study will be introduced will have access to the LifeChamps Dashboard, which will display the data monitored from the patients, thus potentially facilitating patients' follow-up between clinical consultations. The LC Dashboard will provide pseudonymised information regarding the patients' physical activity and PROMs for the purpose of the pilot feasibility trial. They will not be able to view real time processed information, such as risk of frailty, QoL, risk of dependency and psychological condition, from the LIFECHAMPS analytics engine. They will be shown the anonymised outputs of the engine per patient and asked their opinions on the usability, acceptability and on whether such information would have helped better manage their patients' supportive care. | Device | LifeChamps Platform HCP |
| LifeChamps PlatformParticipants will be asked to provide 5 endpoints (PROMS) and will be provided with the study equipment, i.e., a mobile app, smartwatch, smart scale, location home sensor, a smart plug, and a micro-computer, with which they will need to interact with the devices for three months. Specifically, participants should wear the activity tracker wristband (Fitbit Charge 4) as much as possible. Additionally, participants should use the smart scale to weigh themselves and the mobile app to fill in selected PROMs monthly, while the ambient home sensors will be passively collecting information about their everyday living during these three months. At the end of the 3 month period, the participants will return the devices and will be asked to provide the 5 endpoints and their opinions regarding the usability and acceptability of the platform using structured questionnaires | Device | LifeChamps Platform |
Primary outcome
Recruitment rate
Time frame: 7 months
This outcome will be calculated by dividing the number of participants consented over the number of approached participants. It is a ratio between 0 and 1, with 1 being the best outcome.
Participant retention rate
Time frame: 7 months
This outcome will be calculated by dividing the number of participants that finished the study over the number of participants that entered the study. It is a ratio between 0 and 1, with 1 being the best outcome.
Technology Adherence rate
Time frame: 7 months
This outcome will be calculated by dividing the number of times the technology was used over the maximum times that technology can be used over the course of the study. It is a ratio between 0 and 1, with 1 being the best outcome.
4 secondary outcomes
Quality of life Assessment
Time frame: 3 months
Functional Assessment
Time frame: 3 months
Frailty
Time frame: 3 months
Quality of Life Utility Measure
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: Yes. Data collected during the Real-Life pilot study, will be made available for sharing via open access repositories, according to the Final Version of the Data Managements Plan of the project.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Panos D Bamidis, PhD principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeChamps Platform HCP and LifeChamps Platform in people with Breast Cancer and Prostate Cancer, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 10 inclusion and 5 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: finished, as of the sponsor's last update on 1 Mar 2024. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 7 months). The study lists 3 primary outcomes in all. 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 1 Mar 2024.