Breast Cancer FemaleEARLY-HEARTNCT03297346
Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer
A study testing Cardiac imaging and circulating biomarkers in people with Breast Cancer Female, run by French Nuclear Safety and Radiation Protection Authority (ASNR) at 5 sites in 5 countries.
Trial summary
Breast cancer (BC) radiotherapy leads to coincidental radiation of the heart, resulting in increased risk of a variety of heart diseases. Identifying BC patients with the highest risk of radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Cardiac imaging and circulating biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Sep 2017to 31 May 2021
- 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 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female unilateral breast cancer patients
- Treated with primary breast conserving surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS)
- Age between 40-75 years at time of start radiotherapy
- World Health Organisation (WHO) performance status 0-1
- Planned for radiotherapy alone to the breast with or without the lymph node areas
- Radiotherapy based on planning-CT scan using either three dimensional conformal radiation therapy (3D-CRT), Intensity-modulated radiotherapy (IMRT), or Volumetric Arc Therapy (VMAT/RapidArc)
- Written Informed consent
Who cannot join
- Male breast cancer patients
- Neoadjuvant or adjuvant chemotherapy
- M1 disease (metastatic breast cancer)
- Medical history of coronary artery disease and/or myocardial infarction and/or atrial fibrillation
- Previous thoracic or mediastinal radiation
- Contraindications to injection of iodinated contrast such as allergy or renal failure
Show all 11Show fewer
- Pregnancy or lactation
- Atrial fibrillation detected during electrocardiogram before radiotherapy
- Abnormal echocardiography before radiotherapy defined as: Left Ventricular Ejection Fraction<50%; longitudinal strain ≤ -16%; longitudinal strain rate <-1%, and/or abnormal wall motion
- Presence of myocardial infarction detected during MRI before radiotherapy
- CT or MRI results before radiotherapy requiring revascularisation
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Germany1 site
Klinikum rechts der Isar der Technischen Universität München
Munich
Portugal1 site
Associação para Investigação e Desenvolvimento da Faculdade de Medicina
Lisbon
About this study
Official title: Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer (EARLY HEART Study) in the Frame of the Implications of MEDIcal Low Dose RADiation Exposure (MEDIRAD) European Project
Breast cancer (BC) radiotherapy leads to coincidental radiation of the heart, resulting in increased risk of a variety of heart diseases. Identifying BC patients with the highest risk of radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention. Little has been done on the relationship between dose distribution to different anatomical cardiac structures during radiotherapy and early cardiovascular changes that may lead to cardiac complications.
In the framework of the European project MEDIRAD, the EARLY-HEART multicenter prospective cohort was launched in August 2017, involving 5 investigating centers from France, Netherlands, Germany, Spain and Portugal. With 250 BC patients prospectively followed for 2 years, the main objective is to identify and validate the most important cardiac imaging (echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging) and circulating biomarkers of radiation-induced cardiovascular changes arising in the first 2 years after BC radiotherapy.
Read the detailed description
EARLY-HEART is a multicentre prospective cohort study that will include 250 female primary breast cancer cases aged 40-75 years treated with postoperative radiotherapy (RT) alone after breast-conserving surgery using modern planning-CT based RT technologies and followed for 2 years after RT in one of the 5 participating hospitals. In addition to the standard follow-up, patients will need to give repeated blood samples and will undergo repeated cardiac imaging:
- Functional and anatomical cardiac imaging biomarkers will be based on automated 2D-speckle-tracking echocardiography (ECHO-ST); Computed Tomography Coronary Angiography (CT) and cardiac magnetic resonance imaging (MRI).
- Circulating biomarkers (BLOOD) will be based on a panel of multiple classical or novel blood-based biomarkers.
Imaging and circulating biomarkers measurements will be assessed at baseline before RT (ECHO, CT, MRI, BLOOD); at the end of RT (BLOOD); 6 months after RT (ECHO, MRI, BLOOD) and 24 months after RT (ECHO, CT, MRI, BLOOD).
Changes in functional and anatomical cardiac imaging and circulating biomarkers between unexposed status before RT and exposed status after RT at different time points will be first analysed to evaluate the effects of RT on the heart.
All relevant DICOM-data (including planning-CT scans and the ECHO, MRI and CT) will be centralized to the MEDIRAD-ENACT database managed by University of Groningen for automated segmentation of all cardiac substructures (including coronary arteries) to ensure uniformity of the segmentation procedure between centres. The RT planning CTs will be used to generate dose volume histograms and 3D dose maps of the heart and cardiac substructures in order to correlate the localization of any cardiovascular change with the anatomical dose distribution.
In the presence of a cardiac outcome, a multimetric Normal Tissue Complication Probability (NTCP) individual risk model will be constructed and an integrative clinical-biologic risk score will be developed for individual risk prediction.
- Conditions
- Breast Cancer Female
- Being tested
- Cardiac imaging and circulating biomarkers
- Keywords
- radiotherapy, cardiovascular changes, cardiac imaging, circulating biomarkers, dosimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac imaging and circulating biomarkersOther
Automated 2D-speckle-tracking echocardiography (ECHO-ST); Computed tomography coronary angiography (CT); Cardiac magnetic resonance imaging (MRI); Blood samples for circulating biomarkers measurements (BLOOD)
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients treated with RT | Other | Cardiac imaging and circulating biomarkers measurements to evaluate:
* myocardial dysfunction and deformation (ECHO-ST)
* coronary artery lesions and coronary artery calcium score (CT)
* myocardium including tissue abnormalities, cardiac morphology and function (MRI)
* blood-based biomarkers of cardiovascular changes (BLOOD) Receives: Other: Cardiac imaging and circulating biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with decreased myocardial function assessed by echocardiography
Number of patients with an increased of at least 2.5% in the Global Longitudinal Strain (GLS) between baseline and 2 years after radiotherapy
Measured: 2 years after radiotherapy (baseline measurements performed before radiotherapy)
Secondary outcomes (4)
Changes in myocardial function measurements assessed by echocardiography
Increase of the segmental strain measurements (unit of measures:%)
Measured: 6 months and 2 years after radiotherapy (baseline measurements performed before radiotherapy)
Anatomical changes in coronary arteries assessed by cardiac CT
Increase of the number of coronary segments containing any plaque or increase of the calcium score
Measured: 2 years after radiotherapy (baseline measurements performed before radiotherapy)
Myocardial tissue abnormalities assessed by cardiac MRI
Increase of the native mean myocardial T1 mapping value
Measured: 6 months and 2 years after radiotherapy (baseline measurements performed before radiotherapy)
Changes in circulating biomarkers measurements
Significant increase or decrease in the following biomarkers:
classical biomarkers of cardiac injury (C-reactive protein, Troponin I, Troponin T, B-type natriuretic peptide (BNP), N-terminal pro-brain natriuretic peptide (NT-Pro BNP), beta2-Microglobulin, Galectin 3); Inflammatory cytokines; biomarkers of endothelial activation and dysfunction; Microparticles; MicroRNAs; circulating DNA methylation
Measured: at the end of radiotherapy (through radiotherapy completion, an average of 5 weeks after starting date of radiotherapy), 6 months and 2 years after radiotherapy (baseline measurements performed before radiotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Oct 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Nuclear Safety and Radiation Protection Authority (ASNR)
- Sponsor type
- Other government
- Collaborators
- Academisch Ziekenhuis Groningen, Technical University of Munich, Institut Català d'Oncologia, Hospital de Santa Maria, Portugal, University of Paris 5 - Rene Descartes
- Responsible party
- Principal investigator, Sophie JACOB, French Nuclear Safety and Radiation Protection Authority (ASNR)
- Investigators
- Sophie Jacob, PhD, Study chair, Institut de Radioprotection et de Sûreté Nucléaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297346
- Sponsor's protocol ID
- MEDIRAD EARLY-HEART_1.2
- Acronym
- EARLY-HEART
- Status last verified
- Nov 2023
- First submitted
- 21 Sep 2017
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mousseaux E, Craiem D, Vliegenthart R, Jacob S, Eraso A, Constantino Rosa Santos S, Borm K, Langendijk JA, Locquet M, Ventura M, Fiuza M, Combs SE, Spoor DS, Crijns APG; MEDIRAD EARLY-HEART investigators. Cardiac Radiation Dose and Subclinical Coronary Artery Disease Progression after Breast Cancer Radiotherapy: 2-year Cardiac CT Results from the EARLY-HEART Study. Radiol Cardiothorac Imaging. 2026 Jun;8(3):e250342. doi: 10.1148/ryct.250342.
PubMed 42165741Lamy J, Spoor DS, Langendijk JA, Vliegenthart R, Eraso A, Ventura M, Constantino Rosa Santos S, Fiuza M, Kachenoura N, Crijns APG, Mousseaux E; MEDIRAD EARLY-HEART investigators. Cardiac MRI-based Subclinical Cardiac Dysfunction during 2 Years after Breast Cancer Irradiation: The MEDIRAD EARLY-HEART Study. Radiol Cardiothorac Imaging. 2025 Apr;7(2):e240231. doi: 10.1148/ryct.240231.
PubMed 40178396Locquet M, Spoor D, Crijns A, van der Harst P, Eraso A, Guedea F, Fiuza M, Santos SCR, Combs S, Borm K, Mousseaux E, Gencer U, Frija G, Cardis E, Langendijk H, Jacob S. Subclinical Left Ventricular Dysfunction Detected by Speckle-Tracking Echocardiography in Breast Cancer Patients Treated With Radiation Therapy: A Six-Month Follow-Up Analysis (MEDIRAD EARLY-HEART study). Front Oncol. 2022 Jun 28;12:883679. doi: 10.3389/fonc.2022.883679. eCollection 2022.
PubMed 35837099Walker V, Crijns A, Langendijk J, Spoor D, Vliegenthart R, Combs SE, Mayinger M, Eraso A, Guedea F, Fiuza M, Constantino S, Tamarat R, Laurier D, Ferrieres J, Mousseaux E, Cardis E, Jacob S. Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer: Protocol for a European Multicenter Prospective Cohort Study (MEDIRAD EARLY HEART Study). JMIR Res Protoc. 2018 Oct 1;7(10):e178. doi: 10.2196/resprot.9906.
PubMed 30274965
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer (EARLY HEART Study) in the Frame of the Implications of MEDIcal Low Dose RADiation Exposure (MEDIRAD) European Project
- ClinicalTrials.gov ID
- NCT03297346
- Acronym / sponsor ID
- EARLY-HEART / MEDIRAD EARLY-HEART_1.2
- Conditions
- Breast Cancer Female
- Keywords
- radiotherapy, cardiovascular changes, cardiac imaging, circulating biomarkers, dosimetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- French Nuclear Safety and Radiation Protection Authority (ASNR)Other government
- Collaborators
- Academisch Ziekenhuis Groningen, Technical University of Munich, Institut Català d'Oncologia, Hospital de Santa Maria, Portugal, University of Paris 5 - Rene Descartes
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 29 Sep 2017 (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.
Breast cancer (BC) radiotherapy leads to coincidental radiation of the heart, resulting in increased risk of a variety of heart diseases. Identifying BC patients with the highest risk of radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention. Little has been done on the relationship between dose distribution to different anatomical cardiac structures during radiotherapy and early cardiovascular changes that may lead to cardiac complications.
In the framework of the European project MEDIRAD, the EARLY-HEART multicenter prospective cohort was launched in August 2017, involving 5 investigating centers from France, Netherlands, Germany, Spain and Portugal. With 250 BC patients prospectively followed for 2 years, the main objective is to identify and validate the most important cardiac imaging (echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging) and circulating biomarkers of radiation-induced cardiovascular changes arising in the first 2 years after BC radiotherapy.
Detailed description
EARLY-HEART is a multicentre prospective cohort study that will include 250 female primary breast cancer cases aged 40-75 years treated with postoperative radiotherapy (RT) alone after breast-conserving surgery using modern planning-CT based RT technologies and followed for 2 years after RT in one of the 5 participating hospitals. In addition to the standard follow-up, patients will need to give repeated blood samples and will undergo repeated cardiac imaging:
- Functional and anatomical cardiac imaging biomarkers will be based on automated 2D-speckle-tracking echocardiography (ECHO-ST); Computed Tomography Coronary Angiography (CT) and cardiac magnetic resonance imaging (MRI).
- Circulating biomarkers (BLOOD) will be based on a panel of multiple classical or novel blood-based biomarkers.
Imaging and circulating biomarkers measurements will be assessed at baseline before RT (ECHO, CT, MRI, BLOOD); at the end of RT (BLOOD); 6 months after RT (ECHO, MRI, BLOOD) and 24 months after RT (ECHO, CT, MRI, BLOOD).
Changes in functional and anatomical cardiac imaging and circulating biomarkers between unexposed status before RT and exposed status after RT at different time points will be first analysed to evaluate the effects of RT on the heart.
All relevant DICOM-data (including planning-CT scans and the ECHO, MRI and CT) will be centralized to the MEDIRAD-ENACT database managed by University of Groningen for automated segmentation of all cardiac substructures (including coronary arteries) to ensure uniformity of the segmentation procedure between centres. The RT planning CTs will be used to generate dose volume histograms and 3D dose maps of the heart and cardiac substructures in order to correlate the localization of any cardiovascular change with the anatomical dose distribution.
In the presence of a cardiac outcome, a multimetric Normal Tissue Complication Probability (NTCP) individual risk model will be constructed and an integrative clinical-biologic risk score will be developed for individual risk prediction.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients treated with RT | Other | Other: Cardiac imaging and circulating biomarkersCardiac imaging and circulating biomarkers measurements to evaluate: * myocardial dysfunction and deformation (ECHO-ST) * coronary artery lesions and coronary artery calcium score (CT) * myocardium including tissue abnormalities, cardiac morphology and function (MRI) * blood-based biomarkers of cardiovascular changes (BLOOD) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female unilateral breast cancer patients
- Treated with primary breast conserving surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS)
- Age between 40-75 years at time of start radiotherapy
- World Health Organisation (WHO) performance status 0-1
- Planned for radiotherapy alone to the breast with or without the lymph node areas
Key exclusion criteria (11 listed)
- Male breast cancer patients
- Neoadjuvant or adjuvant chemotherapy
- M1 disease (metastatic breast cancer)
- Medical history of coronary artery disease and/or myocardial infarction and/or atrial fibrillation
- Previous thoracic or mediastinal radiation
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 |
|---|---|---|
| Cardiac imaging and circulating biomarkersAutomated 2D-speckle-tracking echocardiography (ECHO-ST); Computed tomography coronary angiography (CT); Cardiac magnetic resonance imaging (MRI); Blood samples for circulating biomarkers measurements (BLOOD) | Other | Breast cancer patients treated with RT |
Primary outcome
Number of patients with decreased myocardial function assessed by echocardiography
Time frame: 2 years after radiotherapy (baseline measurements performed before radiotherapy)
Number of patients with an increased of at least 2.5% in the Global Longitudinal Strain (GLS) between baseline and 2 years after radiotherapy
4 secondary outcomes
Changes in myocardial function measurements assessed by echocardiography
Time frame: 6 months and 2 years after radiotherapy (baseline measurements performed before radiotherapy)
Anatomical changes in coronary arteries assessed by cardiac CT
Time frame: 2 years after radiotherapy (baseline measurements performed before radiotherapy)
Myocardial tissue abnormalities assessed by cardiac MRI
Time frame: 6 months and 2 years after radiotherapy (baseline measurements performed before radiotherapy)
Changes in circulating biomarkers measurements
Time frame: at the end of radiotherapy (through radiotherapy completion, an average of 5 weeks after starting date of radiotherapy), 6 months and 2 years after radiotherapy (baseline measurements performed before radiotherapy)
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 7 Nov 2023.
- Derived from this study: PubMed 42165741Mousseaux E, Craiem D, Vliegenthart R, Jacob S, Eraso A, Constantino Rosa Santos S, Borm K, Langendijk JA, Locquet M, Ventura M, Fiuza M, Combs SE, Spoor DS, Crijns APG; MEDIRAD EARLY-HEART investigators. Cardiac Radiation Dose and Subclinical Coronary Artery Disease Progression after Breast Cancer Radiotherapy: 2-year Cardiac CT Results from the EARLY-HEART Study. Radiol Cardiothorac Imaging. 2026 Jun;8(3):e250342. doi: 10.1148/ryct.250342.
- Derived from this study: PubMed 40178396Lamy J, Spoor DS, Langendijk JA, Vliegenthart R, Eraso A, Ventura M, Constantino Rosa Santos S, Fiuza M, Kachenoura N, Crijns APG, Mousseaux E; MEDIRAD EARLY-HEART investigators. Cardiac MRI-based Subclinical Cardiac Dysfunction during 2 Years after Breast Cancer Irradiation: The MEDIRAD EARLY-HEART Study. Radiol Cardiothorac Imaging. 2025 Apr;7(2):e240231. doi: 10.1148/ryct.240231.
- Derived from this study: PubMed 35837099Locquet M, Spoor D, Crijns A, van der Harst P, Eraso A, Guedea F, Fiuza M, Santos SCR, Combs S, Borm K, Mousseaux E, Gencer U, Frija G, Cardis E, Langendijk H, Jacob S. Subclinical Left Ventricular Dysfunction Detected by Speckle-Tracking Echocardiography in Breast Cancer Patients Treated With Radiation Therapy: A Six-Month Follow-Up Analysis (MEDIRAD EARLY-HEART study). Front Oncol. 2022 Jun 28;12:883679. doi: 10.3389/fonc.2022.883679. eCollection 2022.
- Derived from this study: PubMed 30274965Walker V, Crijns A, Langendijk J, Spoor D, Vliegenthart R, Combs SE, Mayinger M, Eraso A, Guedea F, Fiuza M, Constantino S, Tamarat R, Laurier D, Ferrieres J, Mousseaux E, Cardis E, Jacob S. Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer: Protocol for a European Multicenter Prospective Cohort Study (MEDIRAD EARLY HEART Study). JMIR Res Protoc. 2018 Oct 1;7(10):e178. doi: 10.2196/resprot.9906.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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.
Sophie Jacob, PhD study chair
Institut de Radioprotection et de Sûreté Nucléaire
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac imaging and circulating biomarkers in people with Breast Cancer Female, run by French Nuclear Safety and Radiation Protection Authority (ASNR) at 5 sites in 5 countries.
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 7 inclusion and 11 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany, Netherlands, Portugal, Spain. 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?
Number of patients with decreased myocardial function assessed by echocardiography (time frame: 2 years after radiotherapy (baseline measurements performed before radiotherapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297346, which also lists 4 linked publications.
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 7 Nov 2023.