Breast CancerFRONENCT05720910
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
A study testing GERONTE in people with Breast Cancer and Comorbidities and Coexisting Conditions, run by Institut Bergonié at 11 sites in France.
Trial summary
The primary objective of GERONTE STUDY is to evaluate the effectiveness of the GERONTE, ICT-based, integrated care pathway to improve patient 6-month quality of life, in France. Study design is a stepped wedge randomised controlled trial. Read more about this study
- Who is it for?
- Ages 70 to 130 years
- Conditions the study is for
- Breast Cancer, Comorbidities and Coexisting Conditions, Lung Cancer
- What is being tested?
- GERONTE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 11 sitesFrance
- Study dates
- 15 Oct 2024to 14 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 to 130 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- General inclusion criteria
- Age ≥ 70 years old.
- New or progressive cancer (breast, lung, colorectal, prostate), histologically proven or strong clinical suspicion, fulfilling the tumor specific criteria.
- Estimated life expectancy greater than 6 months.
- At least one moderate/severe multimorbidity inclusion criteria other than current cancer (see separate list under 5.3).
- Patients must be willing and able to comply with study procedures.
Show all 49Show fewer
- Voluntarily signed and dated written informed consents prior to any study specific procedure.
- QLQ-C30 Quality of Life Questionnaire fully completed at baseline, before inclusion.
- Patients affiliated with a French social security scheme in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public health).
- Tumor specific inclusion criteria
- Specific inclusion criteria for breast cancer:
- 9.1. Non-metastatic breast cancer (M0):
- No prior treatment for the current breast cancer.
- All 3 criteria required:
- o Clinical staging: cT2-3-4 Nany, or cTany N1-2-3;
- The cancer specialist considers* surgery;
- The cancer specialist considers* radiotherapy and/or chemotherapy. 9.2. Metastatic breast cancer (M1): Both criteria required:
- The cancer specialist considers* chemotherapy or PARP-inhibitors or mTOR-inhibitors / PIK3CA inhibitors; Previous endocrine therapy +/- CDK4/6 inhibitors is allowed;
- The patient received maximum 1 prior line of chemotherapy for metastatic disease.
- 'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.
- Specific inclusion criteria for colorectal cancer:
- 10.1. Non-metastatic colorectal cancer (M0):
- No prior therapy for the current tumor in the recruiting hospital
- At least one of the 3 criteria required:
- o The cancer specialist considers surgery;
- The cancer specialist considers* radiotherapy;
- The cancer specialist considers* chemotherapy and/or immunotherapy. 10.2. Metastatic colorectal cancer (M1):
- The cancer specialist considers* first or second line systemic therapy and/or radiotherapy (+/- surgery). No previous chemotherapy allowed except adjuvant/perioperative chemotherapy stopped for more than 12 months.
- 'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.
- Specific inclusion criteria for lung cancer:
- 11.1. Non-metastatic lung cancer (M0):
- No prior therapy for the current tumor in the recruiting hospital
- At least one of the 3 criteria required:
- The cancer specialist considers* surgery (patients considered for treatment with percutaneous thermoablation alone are not eligible);
- The cancer specialist considers* radiotherapy (except SBRT);
- The cancer specialist considers* systemic therapy. Possible systemic therapies are chemotherapy and/or immune therapy and/or targeted therapy. Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin analog are not eligible.
- 11.2. Metastatic lung cancer (M1):
- The cancer specialist considers* first or second line systemic therapy. Possible systemic therapies are chemotherapy and/or immune therapy and/or targeted therapy. Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin analog are not eligible.
- 'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.
- 12. Specific inclusion criteria for prostate cancer: 12.1. Non-metastatic prostate cancer (M0): one of the following:
- First diagnosis M0 prostate cancer (no therapy received yet for prostate cancer): at least one of the 2 criteria required:
- o The cancer specialist considers radiotherapy;
- o The cancer specialist considers hormone therapy (ADT +/- combination Abiraterone and Prednisone).
- Salvage treatment M0 prostate cancer (received prior surgery at least 6 months before):
- o The cancer specialist considers radiotherapy (+/- ADT)
- Non-metastatic castration resistant prostate cancer:
- The cancer specialist considers* treatment intensification (ADT + Enzalutamide or Apalutamide or Darolutamide).
- 12.2. Metastatic prostate cancer (M1): - The cancer specialist considers treatment with Abiraterone or Enzalutamide or Apalutamide, or Docetaxel or Cabazitaxel or PARP-inhibitors or Lutetium PSMA.
- 'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.
Who cannot join
- Mental illness/cognitive impairment that limits ability to provide consent or complete trial procedures.
- Participating to an interventional clinical trial with a non-registered anticancer drug or to another geriatric intervention trial.
- Patients and caregivers are unable or unwilling to use ICT-devices (tablet,computer, smartphone) or the Internet according to protocol.
- Patient already included in this study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Centre Hospitalier de la Côte Basque
Bayonne, 64109
Institut Bergonié
Bordeaux, 33076
Groupe Hospitalier Rance Emeraude
Dinan, 22100
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000
Centre Léon Bérard
Lyon, 69373
Centre Azuréen de Cancérologie
Mougins, 06250
Centre Hospitalier Universitaire de Nice
Nice, 06000
Centre Antoine Lacassagne
Nice, 06189
Hôpital Tenon AP-HP
Paris, 75020
Centre Eugène Marquis
Rennes, 35042
Groupe Hospitalier Rance Emeraude
St-Malo, 35400
About this study
Official title: Streamlined Geriatric and Oncological Evaluation Based on ic Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients
The primary objective of GERONTE STUDY is to evaluate the effectiveness of the GERONTE, ICT-based, integrated care pathway to improve patient 6-month quality of life, in France.
Study design is a stepped wedge randomised controlled trial. Clusters will be participating hospitals, comprising eight investigating sites in total (Figure 2).
Read more
This is a stepped wedge of cross-over type. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters will implement the intervention. The investigating sites will be randomly drawn to determine the order in which they will implement the intervention, by "steps" of two months.
The primary endpoint is the Quality of Life assessed by the EORTC QLQ-C30 (version 3.0) questionnaire at 6 months after GERONTE implementation. It has 3 sub-scores that will be analysed independently, with alpha risk adjustment.
Read the detailed description
This is a stepped wedge of cross-over type. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters will implement the intervention. The investigating sites will be randomly drawn to determine the order in which they will implement the intervention, by "steps" of two months. A total of 10 patients by step are to be included in each center; these 10 patients must be regularly included along the 2-month period of each step. If 10 patients are already included before the end of the 2 months' step period, the center has to stop the inclusions till the beginning of the subsequent step. If a center, near to the end of a step, is far from reaching of the 10 patients' inclusion, it must increase the speed of its inclusions to be as close as possible of 10 patients included at the end of the step. In each center, patient sample has to be representative of type of cancer managed in the center, along the trial duration. The repartition of cancer types must be homogeneous along the steps and during the trial duration.
All participating investigating sites will have study collaborators in charge of organizing intervention implementation and data collection. The intervention will be prepared prior to the start of the trial, so that each investigating site can implement it as defined by the randomisation. Each center engaged to participate needs to participate till the end of the trial. A center commitment to participate will be requested before each center involvement to avoid center withdrawal after the start of the trial. Quantitative data regarding the myPatientSpace adapted for GERONTE app usage will be collected at each step and in each cluster by study collaborators, from the beginning of GERONTE system implementation. Care outcome data (Quality of life, anxiety, autonomy, additional hospitalisation, mortality...) will be collected by local referents at 3, 6, 9 and 12 months after inclusion in GERONTE. The data necessary to calculate the real cost of the intervention, of its implementation and of resource use data of patient management will be continuously collected during follow-up. GERONTE patient-centered system implementation and usage will be collected by the local referents in each center. Qualitative analysis will be performed in each center at GERONTE system implementation and during follow-up.
- Conditions
- Breast Cancer, Comorbidities and Coexisting Conditions, Lung Cancer, Colorectal Cancer, Prostate Cancer
- Being tested
- GERONTE
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GERONTEOther
The clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway
| Study group | Role | What they receive |
|---|---|---|
| GERONTE | Experimental | The clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway; Receives: Other: GERONTE |
| CONTROL ARM | No intervention | Patients included in the control arm will be managed according to the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
Quality of life assessed by the quality of life questionnaire (EORTC QLQ-C30) questionnaire at 6 months after inclusion:
- Normalised global health status score
- Normalised score of the physical functioning scale
- Normalised score of the emotional functioning scale the minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result.
Measured: 6 months
Secondary outcomes (14)
Quality of life of elders cancer patients
Scores of the quality of life questionnaire for elderly cancer patients.(QLQ-ELD14). The minimum value is 14 and the maximum value is 40, and higher scores mean a worse result.
Measured: baseline 3, 9 and 12 months
Quality of life by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
The quality of life questionnaire (QLQ-C30) scores. The minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result.
Measured: baseline 3, 9 and 12 months
Survival
Overall survival and progression-free survival
Measured: at 12 months
Patient frailty
Score of the Clinical frailty scale
Measured: baseline, 3, 6, 9 and 12 months
Patient autonomy,
Dependence score of the Activities of Daily Living scale (ADL); Proportion of patients living at home; Number of completed chair stands in 30 seconds
Measured: baseline, 3, 6, 9 and 12 months
Patient weight evolution
Weight in Kilograms
Measured: baseline, 3, 6, 9 and 12 months
Patient anxiety
Score of Hospital Anxiety and Depression (HAD) scale. The minimum value is 0 and the maximum value is 21, and higher scores mean a worse result.
Measured: baseline, 3, 6, 9 and 12 months
institutionalisation
Proportion of patient institutionalised per participants
Measured: 6 and 12 months
unscheduled hospitalisations
Proportion of unscheduled hospitalisations per participants
Measured: 6 and 12 months
Cost per life years gained
using utility assessed through normalised scores of EQ-5D-5L questionnaire
Measured: baseline, 3, 6, 9 and 12 months
Caregiver burden in health, psychological well-being, finances, social life and relationship with patient
Zarit Burden Interview
Measured: baseline, 3, 6, 9 and 12 months
Patient experience of person-centered coordinated care
Person-Centered Coordinated Care Experience Questionnaire (P3CEQ)The minimum value is 0 and the maximum value is 45, and higher scores mean a better result.
Measured: 6 and 12 months
Patient, physician and health-professionals-reported overall satisfaction with the IC technology of the GERONTE system
Score derived from the mHealth App Usability Questionnaire (MAUQ) for standalone mHealth Apps using the Patient version for patient satisfaction and the provider version for physician and health-professional.The minimum value is 0 and the maximum value is 126, and higher scores mean a better result.
Measured: 6 and 12 months
GERONTE patient-centered system implementation and usage
use of the myPatientSpace adapted for GERONTE app measures, for instance: number and frequency of connections.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start15 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completion14 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- EUCLID Clinical Trial Platform, University of Bordeaux
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720910
- Sponsor's protocol ID
- IB2022-03
- Other IDs
- 2022-A01285-38
- Acronym
- FRONE
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hamaker ME, Wildiers H, Ardito V, Arsandaux J, Barthod-Malat A, Davies P, Degol L, Ferrara L, Fourrier C, Kenis C, Kret M, Lalet C, Pelissier SM, O'Hanlon S, Rostoft S, Seghers N, Saillour-Glenisson F, Staines A, Schwimmer C, Thevenet V, Wallet C, Soubeyran P. Study protocol for two stepped-wedge interventional trials evaluating the effects of holistic information technology-based patient-oriented management in older multimorbid patients with cancer: The GERONTE trials. J Geriatr Oncol. 2024 May;15(4):101761. doi: 10.1016/j.jgo.2024.101761. Epub 2024 Apr 5.
PubMed 38581958
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streamlined Geriatric and Oncological Evaluation Based on ic Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients
- ClinicalTrials.gov ID
- NCT05720910
- Acronym / sponsor ID
- FRONE / IB2022-03
- Conditions
- Breast Cancer, Comorbidities and Coexisting Conditions, Lung Cancer, Colorectal Cancer, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- EUCLID Clinical Trial Platform, University of Bordeaux
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- 14 Apr 2027 (estimated)
- First posted
- 9 Feb 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 primary objective of GERONTE STUDY is to evaluate the effectiveness of the GERONTE, ICT-based, integrated care pathway to improve patient 6-month quality of life, in France.
Study design is a stepped wedge randomised controlled trial. Clusters will be participating hospitals, comprising eight investigating sites in total (Figure 2).
This is a stepped wedge of cross-over type. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters will implement the intervention. The investigating sites will be randomly drawn to determine the order in which they will implement the intervention, by "steps" of two months.
The primary endpoint is the Quality of Life assessed by the EORTC QLQ-C30 (version 3.0) questionnaire at 6 months after GERONTE implementation. It has 3 sub-scores that will be analysed independently, with alpha risk adjustment.
Detailed description
This is a stepped wedge of cross-over type. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters will implement the intervention. The investigating sites will be randomly drawn to determine the order in which they will implement the intervention, by "steps" of two months. A total of 10 patients by step are to be included in each center; these 10 patients must be regularly included along the 2-month period of each step. If 10 patients are already included before the end of the 2 months' step period, the center has to stop the inclusions till the beginning of the subsequent step. If a center, near to the end of a step, is far from reaching of the 10 patients' inclusion, it must increase the speed of its inclusions to be as close as possible of 10 patients included at the end of the step. In each center, patient sample has to be representative of type of cancer managed in the center, along the trial duration. The repartition of cancer types must be homogeneous along the steps and during the trial duration.
All participating investigating sites will have study collaborators in charge of organizing intervention implementation and data collection. The intervention will be prepared prior to the start of the trial, so that each investigating site can implement it as defined by the randomisation. Each center engaged to participate needs to participate till the end of the trial. A center commitment to participate will be requested before each center involvement to avoid center withdrawal after the start of the trial. Quantitative data regarding the myPatientSpace adapted for GERONTE app usage will be collected at each step and in each cluster by study collaborators, from the beginning of GERONTE system implementation. Care outcome data (Quality of life, anxiety, autonomy, additional hospitalisation, mortality...) will be collected by local referents at 3, 6, 9 and 12 months after inclusion in GERONTE. The data necessary to calculate the real cost of the intervention, of its implementation and of resource use data of patient management will be continuously collected during follow-up. GERONTE patient-centered system implementation and usage will be collected by the local referents in each center. Qualitative analysis will be performed in each center at GERONTE system implementation and during follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GERONTE | Experimental | Other: GERONTEThe clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway; |
| CONTROL ARM | No intervention | –Patients included in the control arm will be managed according to the standard of care. |
Who may qualify
- Ages
- 70 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (49 listed)
- General inclusion criteria
- Age ≥ 70 years old.
- New or progressive cancer (breast, lung, colorectal, prostate), histologically proven or strong clinical suspicion, fulfilling the tumor specific criteria.
- Estimated life expectancy greater than 6 months.
- At least one moderate/severe multimorbidity inclusion criteria other than current cancer (see separate list under 5.3).
Key exclusion criteria (4 listed)
- Mental illness/cognitive impairment that limits ability to provide consent or complete trial procedures.
- Participating to an interventional clinical trial with a non-registered anticancer drug or to another geriatric intervention trial.
- Patients and caregivers are unable or unwilling to use ICT-devices (tablet,computer, smartphone) or the Internet according to protocol.
- Patient already included in this study.
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 |
|---|---|---|
| GERONTEThe clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway | Other | GERONTE |
Primary outcome
Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
Time frame: 6 months
Quality of life assessed by the quality of life questionnaire (EORTC QLQ-C30) questionnaire at 6 months after inclusion: * Normalised global health status score * Normalised score of the physical functioning scale * Normalised score of the emotional functioning scale the minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result.
14 secondary outcomes
Quality of life of elders cancer patients
Time frame: baseline 3, 9 and 12 months
Quality of life by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
Time frame: baseline 3, 9 and 12 months
Survival
Time frame: at 12 months
Patient frailty
Time frame: baseline, 3, 6, 9 and 12 months
Patient autonomy,
Time frame: baseline, 3, 6, 9 and 12 months
Patient weight evolution
Time frame: baseline, 3, 6, 9 and 12 months
Patient anxiety
Time frame: baseline, 3, 6, 9 and 12 months
institutionalisation
Time frame: 6 and 12 months
unscheduled hospitalisations
Time frame: 6 and 12 months
Cost per life years gained
Time frame: baseline, 3, 6, 9 and 12 months
Caregiver burden in health, psychological well-being, finances, social life and relationship with patient
Time frame: baseline, 3, 6, 9 and 12 months
Patient experience of person-centered coordinated care
Time frame: 6 and 12 months
Patient, physician and health-professionals-reported overall satisfaction with the IC technology of the GERONTE system
Time frame: 6 and 12 months
GERONTE patient-centered system implementation and usage
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 38581958Hamaker ME, Wildiers H, Ardito V, Arsandaux J, Barthod-Malat A, Davies P, Degol L, Ferrara L, Fourrier C, Kenis C, Kret M, Lalet C, Pelissier SM, O'Hanlon S, Rostoft S, Seghers N, Saillour-Glenisson F, Staines A, Schwimmer C, Thevenet V, Wallet C, Soubeyran P. Study protocol for two stepped-wedge interventional trials evaluating the effects of holistic information technology-based patient-oriented management in older multimorbid patients with cancer: The GERONTE trials. J Geriatr Oncol. 2024 May;15(4):101761. doi: 10.1016/j.jgo.2024.101761. Epub 2024 Apr 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GERONTE in people with Breast Cancer and Comorbidities and Coexisting Conditions, run by Institut Bergonié at 11 sites in France.
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 49 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 ) (time frame: 6 months). 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 NCT05720910, which also lists 1 linked publication.
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 13 Oct 2026.