Advanced CancerALIGNNCT06616298
ALIGN for Older Adults With Cancer in SNFs
A study testing Assessing and Listening to Individual Goals and Needs (ALIGN) in people with Advanced Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if it is possible to deliver a palliative care intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) to hospitalized older adults with advanced cancer who are discharged to a skilled nursing facility and their caregivers. Read more about this study
- Who is it for?
- Ages 18 to 98 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Assessing and Listening to Individual Goals and Needs (ALIGN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to 1 Aug 2028
- 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 18 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18-98 years
- Stage I-IV solid tumors
- Discharging from an acute care hospital to a SNF in Colorado
- English speaking
- Receiving or establishing care at the University of Colorado Cancer Center
- If a patient lacks capacity, a legal surrogate decision-maker will be approached to provide proxy consent.
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- Must have access to the technology needed to complete consenting visit and subsequent intervention visits. This includes internet access through a computer, tablet, or smartphone OR cellular service with adequate allowance of cellular minutes to allow virtual visits.
- Must have an email address or caregiver with an email address to facilitate communication during the trial
- Patient-selected
- Age ≥ 18
- English speaking
- Able to complete baseline measures.
- 1. Working at a SNF that cared for a patient who received the ALIGN intervention
- 1. PCSWs who conducted the ALIGN intervention and consent to an interview
Who cannot join
- Discharging with hospice care
- Age less than 18
- Lacking capacity without a legal surrogate decision maker or proxy.
- Limited English proficiency
- Hospitalized for a planned admission or procedure
- Have any pschological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgement of the PI or relevant clinical study staff that would make a participant unsuitable for the study
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- Caregivers
- Discharging with hospice care
- Age ≤ 18
- Caregivers with limited English proficiency will be excluded as ALIGN intervention content and documents have only been validated in an English-speaking population.
- Have any pschological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgement of the PI or relevant clinical study staff that would make a participant unsuitable for the study
- SNF Staff
- 1. Not employed by a community SNF where patients were discharged to during the pilot trial
- PCSW
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Sarguni Singh, MD, 503.703.0797, sarguni.singh@cuanschutz.edu
Sarguni Singh, MD
About this study
Official title: Improving Person-Centered Outcomes for Older Adults With Cancer Discharged to Skilled Nursing Facilities and Their Family Caregivers
The goal of this clinical trial is to learn if it is possible to deliver a palliative care intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) to hospitalized older adults with advanced cancer who are discharged to a skilled nursing facility and their caregivers. The main questions it aims to answer are:
- Can the investigator successfully deliver the ALIGN intervention in different skilled community nursing facilities?
- Can the investigator successfully collect information from participants throughout the study?
- How can the investigator best prepare caregivers to make medical decisions for loved ones that become unable to do so themselves?
Read more
Researchers will compare ALIGN to care as it is usually delivered.
Participants will:
- Visit virtually with an ALIGN palliative care social worker every 1-2 weeks during their skilled nursing facility stay and up to 45 days after discharge from the facility or will see a palliative care clinician if recommended by their oncologist or other involved clinician.
- Participants will provide information about how they are doing 1 month, 3 months, and 6 months after enrolling in the study.
- Conditions
- Advanced Cancer
- Being tested
- Assessing and Listening to Individual Goals and Needs (ALIGN)
- Keywords
- Skilled Nursing Facility, Caregiver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessing and Listening to Individual Goals and Needs (ALIGN)Other
Assessing and Listening to Individual Goals and Needs (ALIGN). ALIGN utilizes the skills of palliative care social workers (PCSWs) trained in family and systems-level theory to address changing preferences for care, family distress, and to facilitate communication across care transitions to improve care aligned with preferences. A patient navigator supports the patient/caregiver and social worker dynamic by helping patients access care and resources. The intervention is implemented virtually in community SNFs and follows patients for 45 days after SNF discharge to reflect real-world patient flow.
| Study group | Role | What they receive |
|---|---|---|
| Older patients with advanced cancer | Experimental | Older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities (SNF). Receives: Other: Assessing and Listening to Individual Goals and Needs (ALIGN) |
| Caregivers of older patients with advanced cancer | Experimental | Caregivers of older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities. Receives: Other: Assessing and Listening to Individual Goals and Needs (ALIGN) |
| Control Arm | No intervention | Control arm participants will receive enhanced usual care. Patients will be provided resources for advance care planning and interact with SNF staff and involved providers who may refer them to palliative care or hospice like previous rigorous palliative care trials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention fidelity as assessed by fidelity checklist
Intervention fidelity will be assessed using a fidelity checklist. ALIGN will be considered feasible if at least one component of ≥ 80% of domains on the fidelity checklist are addressed, ≥ 50% of components of at least 1 intervention domain are delivered in follow up visits, and if a discharge note is entered for enrolled patients.
Measured: 2.5 years
Intervention fidelity as assessed by audio-recordings
Intervention visits will be recorded and reviewed to assess fidelity to the core intervention components of ALIGN.
Measured: 2.5 years
Assessment of treatment contamination in community skilled nursing facilities
The investigators will determine the proportion (% total) of caregivers in the control arm who reported that they received components of the ALIGN intervention during the skilled nursing facility stay. ALIGN will be considered feasible if contamination where ALIGN effects usual care is less than 10%.
Measured: 2.5 years
The proportion (% total) of screened patients that are eligible for enrollment in the trial
The investigators will determine the proportion of screened patients (% total) who meet the inclusion criteria
Measured: 2.5 years
The proportion (% total) of enrolled patients that are assessed for patient-centered outcomes
The investigators will determine the proportion of (% total) of enrolled patients that are succesfully assessed for patient-reported and patient-centered outcomes (please see secondary outcomes below)
Measured: 2.5 years
The proportion (% total) of enrolled caregivers that are assessed for person-centered outcomes
The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully assessed for person-centered outcomes (please see secondary outcomes below)
Measured: 2.5 years
The proportion (% total) of enrolled patients that are randomized
The investigators will determine the proportion of (% total) of enrolled patients that are succesfully randomized
Measured: 2.5 years
The proportion (% total) of enrolled caregivers that are randomized
The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully randomized
Measured: 2.5 years
Secondary outcomes (15)
Assessing changes in days at home
In this exploratory outcome measure, days at home will be calculated as 180 days minus the number of inpatient days in an acute care facility, an inpatient rehabilitation facility, a skilled nursing facility, or an inpatient hospice unit.
Measured: 6 months after randomization
Assessing Changes in hospice length of stay
In this exploratory outcome measures, changes in the length of a hospice stay in both arms of the clinical trial will be measured
Measured: 6 months after randomization
Health Care Utilization
Rehospitalization and emergency department visits for any cause and receipt of chemotherapy within 14 days of death will be collected
Measured: 6 months after randomization
Change in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-PAL-14)
In this exploratory outcome measure, patients will be asked to complete this 14 item Likert-type scale that measures four primary quality of life domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and spiritual well-being. Scores range from 0-56. Lower scores indicate lower quality of life.
Measured: At enrollment and then at 1, 3, and 6 months after randomization
Changes in agreement with health-related outcome statements as assessed by the Attitude Scale
In this exploratory outcome measure, patients will be asked to complete the Attitude Scale which is a 5-point Likert scale that identifies the extent to which patients agree with 8 health-related outcome statements such as: The most important thing to me is living as long as I can, no matter what my quality of life is. Changes in agreement will be measured in both groups of the trial.
Measured: From enrollment and then 1, 3 and 6 months after randomization
Change in frailty as assessed by the Practical Geriatric Assessment
In this exploratory outcome measure, patients and caregivers will be asked to complete this 19 item assessment measures individual domain impairments in areas of physical function, nutrition/weight loss, social support, psychological, comorbidities, and cognitive functioning to guide treatment decisions. There is no composite score for this measure, rather scores from each domain help identify impairments. Higher scores in the physical function, comorbidities, psychological health, domain suggest greater impairment. Lower scores in cognitive and nutritional domains suggest greater impairment.
Measured: From enrollment and then 1, 3, and 6 months after randomization
Change in Advance Care Planning Documentation
Advance Care Planning documents such as Medical Durable Power of Attorney (MDPOA) forms, cardiopulmonary resuscitation (CPR) directives, and the Medical Orders for Scope of Treatment (MOST) forms are documents that communicate end of life wishes for patients and also who they would designate to make medical decisions on their behalf if they are unable to do so themselves. We are measuring completion rates and changes to wishes expressed in these documents in all patients who participate in the trial.
Measured: From enrollment and then at 6 months after randomization
Changes in the Perception of Patient Centeredness of Care Delivered as assessed by the Perception of Patient Centeredness of Care Measure
In this exploratory outcome measure, patients and caregivers will be asked to complete this 18-item instrument using a 4-point Likert scale. Scores range from 18 -72. Higher scores indicate a greater perception of patient-centeredness of care.
Measured: At enrollment and then 1, 3, and 6 months after randomization
Changes in caregiver coping as assessed by the Brief-Cope Questionaire
This scale ascertains how people are responding emotionally to a serious circumstance and will be completed by caregivers in this study as an exploratory outcome measure. Scores are presented over three overarching coping styles (problem-focused, emotion-focused, and avoidant) as average scores indicating the degree to which the respondent has been engaging in that coping style. Scores for each coping strategy can range from 2-8. We will measure changes in coping styles over the course of the trial.
Measured: At enrollment and 1, 3, and 6 months after randomization
Changes in illness understanding and coping support as assessed by the Advanced Illness Coordinating Care Survey
In this exploratory outcome measure, this 5 question survey assesses perceived illness understanding and coping support. The range of scores is from 0 - 24 with higher scores indicating increased illness understanding and coping support.
Measured: At enrollment and then 1, 3, and 6 months after randomization
Changes in the experience of feeling heard and understood as assessed by the Heard and Understood Survey
In this exploratory outcome measure, this 4 question Likert scale survey will be completed by patients and caregivers to assess how well they felt heard and understood by their oncology team of clinicians. Scores can range from 0-16. Higher scores indicate delivery of higher quality care.
Measured: At enrollment and then 1, 3, and 6 months after randomization
Change in the burden or benefits of caregiving as assessed by the Caregiver Reaction Assessment
In this exploratory outcome measure, caregivers will be asked to complete this 24 item instrument designed to measure the reactions of family members to caring for adults with a variety of illness. The instrument focuses on five dimensions: caregiver esteem, lack of family support, impact on finances, impact on schedule, and impact on health. The minimum score is 0 and the maximum score is 24. A higher score indicates greater caregiver burden.
Measured: At enrollment and then at 1, 3 and 6 months after randomization
Changes in congruence between patient and oncologist understanding of the goals of treatment
In this exploratory outcome measure, patients, caregivers, and oncologists will be asked a focus of treatment question (Please select one of the options below that best describes your current focus of treatment) and asked to select from the following options: curative, life prolonging/rehabilitative, or comfort focused. Patients, caregivers, and oncologists will be asked this question at enrollment and when patients are discharged from ALIGN after the protocol has been completed. We are measuring whether there is increased congruence in the response between patient and their oncologists.
Measured: At enrollment and then post-intervention protocol completion
Assessing Oncology Clinican Acceptability
Involved oncology clinicians will be asked using a Likert scale survey their experience working with the ALIGN social worker conducting the intervention in this exploratory outcome measure.
Measured: After completion of the ALIGN protocol
Assessing the Bereaved Caregivers Satisfaction with Care During the Last Month of Life
In this exploratory outcome, bereaved caregivers will be asked to complete a 10-item validated bereaved family survey assessing their satisfaction with end-of-life care received by the patient. Domains assessed will include physical and emotional support, focus on the individual, and shared decision making. Higher scores indicate greater satisfaction with care.
Measured: 1 month or later after patient death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start24 Feb 2025
- Primary completion24 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sarguni Singh, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616298
- Sponsor's protocol ID
- 24-0548.cc
- Other IDs
- K23AG076866
- Acronym
- ALIGN
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Person-Centered Outcomes for Older Adults With Cancer Discharged to Skilled Nursing Facilities and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT06616298
- Acronym / sponsor ID
- ALIGN / 24-0548.cc
- Conditions
- Advanced Cancer
- Keywords
- Skilled Nursing Facility, Caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 24 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 27 Sep 2024 (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 goal of this clinical trial is to learn if it is possible to deliver a palliative care intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) to hospitalized older adults with advanced cancer who are discharged to a skilled nursing facility and their caregivers. The main questions it aims to answer are:
- Can the investigator successfully deliver the ALIGN intervention in different skilled community nursing facilities?
- Can the investigator successfully collect information from participants throughout the study?
- How can the investigator best prepare caregivers to make medical decisions for loved ones that become unable to do so themselves?
Researchers will compare ALIGN to care as it is usually delivered.
Participants will:
- Visit virtually with an ALIGN palliative care social worker every 1-2 weeks during their skilled nursing facility stay and up to 45 days after discharge from the facility or will see a palliative care clinician if recommended by their oncologist or other involved clinician.
- Participants will provide information about how they are doing 1 month, 3 months, and 6 months after enrolling in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Older patients with advanced cancer | Experimental | Other: Assessing and Listening to Individual Goals and Needs (ALIGN)Older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities (SNF). |
| Caregivers of older patients with advanced cancer | Experimental | Other: Assessing and Listening to Individual Goals and Needs (ALIGN)Caregivers of older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities. |
| Control Arm | No intervention | –Control arm participants will receive enhanced usual care. Patients will be provided resources for advance care planning and interact with SNF staff and involved providers who may refer them to palliative care or hospice like previous rigorous palliative care trials. |
Who may qualify
- Ages
- 18 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adults between 18-98 years
- Stage I-IV solid tumors
- Discharging from an acute care hospital to a SNF in Colorado
- English speaking
- Receiving or establishing care at the University of Colorado Cancer Center
Key exclusion criteria (14 listed)
- Discharging with hospice care
- Age less than 18
- Lacking capacity without a legal surrogate decision maker or proxy.
- Limited English proficiency
- Hospitalized for a planned admission or procedure
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 |
|---|---|---|
| Assessing and Listening to Individual Goals and Needs (ALIGN)Assessing and Listening to Individual Goals and Needs (ALIGN). ALIGN utilizes the skills of palliative care social workers (PCSWs) trained in family and systems-level theory to address changing preferences for care, family distress, and to facilitate communication across care transitions to improve care aligned with preferences. A patient navigator supports the patient/caregiver and social worker dynamic by helping patients access care and resources. The intervention is implemented virtually in community SNFs and follows patients for 45 days after SNF discharge to reflect real-world patient flow. | Other | Caregivers of older patients with advanced cancer, Older patients with advanced cancer |
Primary outcome
Intervention fidelity as assessed by fidelity checklist
Time frame: 2.5 years
Intervention fidelity will be assessed using a fidelity checklist. ALIGN will be considered feasible if at least one component of ≥ 80% of domains on the fidelity checklist are addressed, ≥ 50% of components of at least 1 intervention domain are delivered in follow up visits, and if a discharge note is entered for enrolled patients.
Intervention fidelity as assessed by audio-recordings
Time frame: 2.5 years
Intervention visits will be recorded and reviewed to assess fidelity to the core intervention components of ALIGN.
Assessment of treatment contamination in community skilled nursing facilities
Time frame: 2.5 years
The investigators will determine the proportion (% total) of caregivers in the control arm who reported that they received components of the ALIGN intervention during the skilled nursing facility stay. ALIGN will be considered feasible if contamination where ALIGN effects usual care is less than 10%.
The proportion (% total) of screened patients that are eligible for enrollment in the trial
Time frame: 2.5 years
The investigators will determine the proportion of screened patients (% total) who meet the inclusion criteria
The proportion (% total) of enrolled patients that are assessed for patient-centered outcomes
Time frame: 2.5 years
The investigators will determine the proportion of (% total) of enrolled patients that are succesfully assessed for patient-reported and patient-centered outcomes (please see secondary outcomes below)
The proportion (% total) of enrolled caregivers that are assessed for person-centered outcomes
Time frame: 2.5 years
The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully assessed for person-centered outcomes (please see secondary outcomes below)
The proportion (% total) of enrolled patients that are randomized
Time frame: 2.5 years
The investigators will determine the proportion of (% total) of enrolled patients that are succesfully randomized
The proportion (% total) of enrolled caregivers that are randomized
Time frame: 2.5 years
The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully randomized
15 secondary outcomes
Assessing changes in days at home
Time frame: 6 months after randomization
Assessing Changes in hospice length of stay
Time frame: 6 months after randomization
Health Care Utilization
Time frame: 6 months after randomization
Change in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-PAL-14)
Time frame: At enrollment and then at 1, 3, and 6 months after randomization
Changes in agreement with health-related outcome statements as assessed by the Attitude Scale
Time frame: From enrollment and then 1, 3 and 6 months after randomization
Change in frailty as assessed by the Practical Geriatric Assessment
Time frame: From enrollment and then 1, 3, and 6 months after randomization
Change in Advance Care Planning Documentation
Time frame: From enrollment and then at 6 months after randomization
Changes in the Perception of Patient Centeredness of Care Delivered as assessed by the Perception of Patient Centeredness of Care Measure
Time frame: At enrollment and then 1, 3, and 6 months after randomization
Changes in caregiver coping as assessed by the Brief-Cope Questionaire
Time frame: At enrollment and 1, 3, and 6 months after randomization
Changes in illness understanding and coping support as assessed by the Advanced Illness Coordinating Care Survey
Time frame: At enrollment and then 1, 3, and 6 months after randomization
Changes in the experience of feeling heard and understood as assessed by the Heard and Understood Survey
Time frame: At enrollment and then 1, 3, and 6 months after randomization
Change in the burden or benefits of caregiving as assessed by the Caregiver Reaction Assessment
Time frame: At enrollment and then at 1, 3 and 6 months after randomization
Changes in congruence between patient and oncologist understanding of the goals of treatment
Time frame: At enrollment and then post-intervention protocol completion
Assessing Oncology Clinican Acceptability
Time frame: After completion of the ALIGN protocol
Assessing the Bereaved Caregivers Satisfaction with Care During the Last Month of Life
Time frame: 1 month or later after patient death
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 5 May 2026.
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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.
Sarguni Singh, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessing and Listening to Individual Goals and Needs (ALIGN) in people with Advanced Cancer, run by University of Colorado, Denver at 1 site in United States.
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 14 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 United States. 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?
Contact Sarguni Singh, MD (503.703.0797, sarguni.singh@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention fidelity as assessed by fidelity checklist (time frame: 2.5 years). The study lists 8 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 5 May 2026.