Educational Materials for Genetic TestingIMAGINENCT04751435
Developing New Educational Materials About Genetic Testing for a Diverse Group of Cancer Patients
A study testing Cognitive interview and LCAM intervention in people with Educational Materials for Genetic Testing and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
Genetic testing is a type of test that detects changes to the genes-the DNA instructions that are passed on from the mother and father. The results of a genetic test can confirm whether the participant has a genetic disorder, which is a disease caused in whole or in part by changes to the genes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Educational Materials for Genetic Testing, Breast Cancer, Ovarian Cancer
- What is being tested?
- Cognitive interview and LCAM intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 445 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Nov 2021to 31 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1
- Age ≥ 18 years as per self-report
- Current or previous diagnosis of breast, ovarian, pancreatic, or prostate cancer as per self-report
- Self-identification as Black, Latino, and/or neither Black nor Latino (i.e.,non-Latino, Non black)
- Fluency in English, Haitian Creole, or Spanish as per self-report (for Spanish, we will attempt to recruit a cohort representing a variety of regions where Spanish is spoken, as informed by current data from participating sites, to achieve neutrality in the language) Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken and reading ability.
- Phase 2:
Show all 24Show fewer
- Age ≥ 18 years as per the medical record and/or clinician referral
- Current or previous diagnosis of breast, colorectal, ovarian, pancreatic, or prostate cancer meeting at least one of the applicable criteria for the cancer type as per the medical record and/or clinician referral:
- Breast cancer criteria:
- any diagnosis age 65 or younger;
- diagnosis of triple negative breast cancer at any age;
- multiple primary breast cancers at any age;
- under consideration for PARP therapy;
- any family history (1st, 2nd, or 3rd degree relatives) of ovarian or pancreas cancer, or 1 relative with breast cancer who meets the above criteria, or 2 relatives with breast cancer at any age; or clinician discretion)
- colorectal cancer
- Ovarian cancer criteria:
- invasive ovarian cancer
- Pancreatic cancer criteria:
- pancreatic adenocarcinoma
- Prostate cancer criteria:
- castrate-resistant, metastatic prostate cancer;
- high-risk prostate cancer (pending pathology definition)
- Fluency in English, Haitian Creole, or Spanish as per self-report. Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken ability
- No prior cancer genetic counseling or germline testing for cancer risk as per self-report clinician's note, and/or no clinical documentation
Who cannot join
- Phase 1:
- Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment.
- Subjects who indicate level of fluency as "not at all" or "not well".
- Phase 2:
- Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment.
- Subjects who indicate level of fluency as "not at all" or "not well".
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Hay, PhD contact
United States4 sites, 4 recruiting
- Recruiting
Kings County Hopsital Center
Brooklyn, New York, 11203
Jason Gonsky, MD, (718) 245-2847
- Recruiting
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Linda Bulone, RN, OCN, CCRC, (718) 883-2958
- Recruiting
Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
New York, New York, 10035
Jada Hamilton, PhD, MPH, 646-888-0049
- Recruiting
Jamaica Hospital Medical Center (Data Collection Only)
Richmond Hill, New York, 11418
Rosa Nouvini, MD, (718) 206-6000
About this study
Official title: IMAGINE: IMproving Access to Genetic INformation for Everyone - A Prospective Trial of a Linguistically and Culturally Appropriate Mainstreaming Model for Hereditary Cancer Multigene Panel Testing Among Diverse Cancer Patients
Genetic testing is a type of test that detects changes to the genes-the DNA instructions that are passed on from the mother and father. The results of a genetic test can confirm whether the participant has a genetic disorder, which is a disease caused in whole or in part by changes to the genes. Genetic testing can also help determine a person's chance of getting or passing on a genetic disorder. Genetic tests use a sample of blood, hair, skin, or other tissue, and they can look at one gene or multiple genes at the same time. Genetic testing may change the options for treating people with certain types of cancer. For example, some medications are more helpful for the treatment of cancer in people with certain gene changes (mutations).
The researchers are doing this study to develop new educational materials about genetic testing for people who speak different languages and have diverse cultural and educational backgrounds. During the study, the staff will interview participants with diverse cultural and educational backgrounds and ask them to review a sample of the educational materials that have been developed so far. Participants will give their opinions on these materials, and the researchers will use participants' feedback to improve the materials.
Read the detailed description
The objective of this proposal is to develop, test and evaluate a mainstreaming (LCAM) model for hereditary cancer multigene panel testing (MGPT) among many different types of cancer patients. The central hypothesis is that this LCAM genetic testing model will lead to better patient decision-making, psychosocial, and behavioral outcomes than a traditional model of genetic services represented by our standard-of-care arm. In Phase 1, the researchers will first conduct formative research including transcreation and cognitive interviewing to adapt our existing educational materials (brochure and video) and clinical communication materials (clinic visit summary and family dissemination messaging) for the LCAM model to be useful for patients of many different backgrounds. In Phase 2, the researchers will conduct a randomized clinical trial (RCT) to test and evaluate effects of the LCAM model for hereditary cancer MGPT as compared to standard-of-care among the patients treated at local community hospitals. Patients diagnosed with breast, colorectal, ovarian, pancreatic, or prostate cancer will be offered hereditary cancer MGPT through either: i) standard-of-care wherein in-depth pre-test and post-test genetic counseling are provided via telegenetics (videoconferencing), or ii) LCAM intervention wherein patients receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials. Participants will be followed prospectively and will complete assessments consisting of validated and investigator-designed measures. Phase 2 primary outcomes include genetic test decision satisfaction and genetic counseling satisfaction. Secondary outcomes include additional decision-making, psychosocial, and behavioral outcomes.
For Phase 2, participants will be recruited from our partnering sites, which include Kings County Hospital Center, Queens Cancer Center, Jamaica Hospital Medical Center, and the MSK Ralph Lauren Center for Cancer Care as well via referrals from underserved community sites through the MSK RLCCC network. Study staff will identify eligible patients from review of clinic lists and patient medical records, and will also receive direct study referrals from clinicians located at the partnering sites. Study staff will approach eligible patients in order to describe the study, screen them for eligibility (including assessing language proficiency via self-report and prior experience with cancer genetic counseling/testing), and obtain informed consent and collect their contact information.
- Conditions
- Educational Materials for Genetic Testing, Breast Cancer, Ovarian Cancer, Prostate Cancer, Pancreatic Cancer, Colorectal Cancer
- Being tested
- Cognitive interview, LCAM intervention, Standard of care
- Keywords
- Educational Materials, Genetic Testing, Hereditary Cancer, Diverse Cancer Patients, Colorectal Cancer, 20-458
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive interviewOther
Researchers will use formative methods to adapt our previously-developed mainstreaming pre-genetic test educational materials plus standard post-test clinical communication materials used by the MSK CGS for use with the diverse patients. Specifically, it will adapt these materials to be responsive to patients' linguistic and literacy needs, and sensitive to their cultural diversity.
LCAM interventionBehavioural
Participants will receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials.
Standard of careBehavioural
Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics
| Study group | Role | What they receive |
|---|---|---|
| Cognitive interview intervention for Phase 1 | Experimental | There is no treatment or intervention for Phase 1 of this study. Participants will be asked to participate in a cognitive interview.
This section will be amended to include the Phase 2 intervention information once the Phase 1 portion of the study is complete. The Phase 1 materials developed, and results obtained, will directly be part of and inform the intervention for Phase 2.Phase 2: participants will be randomized to the standard-of-care arm or the LCAM intervention arm. Receives: Other: Cognitive interview |
| Standard of care (Phase II only randomization) | Active comparator | Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics Receives: Behavioral: Standard of care |
| LCAM Intervention (Phase II only randomization) | Active comparator | Participants will receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials. Receives: Behavioral: LCAM intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who complete the cognitive interview (Phase I)
the number of patients who complete the cognitive interview
Measured: 1 year
Genetic test decision (Phase II) satisfaction
is measured with the validated Satisfaction with Decisions scale.
Measured: 6 months
Genetic counseling satisfaction (Phase II)
is measured with the validated Genetic Counseling Satisfaction scale
Measured: 6 months
Secondary outcomes (9)
Test uptake (Phase II)
the number of patients who complete multigene panel testing
Measured: 6 months
Knowledge (Phase II)
measured with items from the validated KnowGene scale (scores range from 0 to 6, higher scores indicate greater knowledge)
Measured: 6 months
Empowerment (Phase II)
measured with the validated Genomics Outcome Scale (scores range from 6 to 30, higher scores indicate greater empowerment)
Measured: 6 months
Distress (Phase II)
measured with the validated Hospital Anxiety and Depression Scale (total scale scores range from 0 to 42, higher scores indicate greater distress)
Measured: 6 months
Concerns about genetic testing (Phase II)
measured with the validated Multidimensional Impact of Cancer Risk Assessment questionnaire (total scale scores range from 0 to 95, higher scores indicate greater concerns about genetic testing)
Measured: 6 months
Family communication (Phase II)
measured with investigator-designed items
Measured: 6 months
Family cascade testing (Phase II)
the number of first-degree relatives who complete genetic testing
Measured: 6 months
Intentions to adopt risk management behaviors (Phase II)
measured with items derived from the Behavioral Risk Factor Surveillance System and National Health Interview Survey
Measured: 6 months
Long term engagement and understanding (Phase II)
measured with investigator-designed items
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 posted12 Feb 2021
- Study start16 Nov 2021
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational Materials for Genetic TestingStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 445 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jada Hamilton, PhD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751435
- Sponsor's protocol ID
- 20-458
- Acronym
- IMAGINE
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMAGINE: IMproving Access to Genetic INformation for Everyone - A Prospective Trial of a Linguistically and Culturally Appropriate Mainstreaming Model for Hereditary Cancer Multigene Panel Testing Among Diverse Cancer Patients
- ClinicalTrials.gov ID
- NCT04751435
- Acronym / sponsor ID
- IMAGINE / 20-458
- Conditions
- Educational Materials for Genetic Testing, Breast Cancer, Ovarian Cancer, Prostate Cancer, Pancreatic Cancer, Colorectal Cancer
- Keywords
- Educational Materials, Genetic Testing, Hereditary Cancer, Diverse Cancer Patients, Colorectal Cancer, 20-458
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 445 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 Feb 2021 (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.
Genetic testing is a type of test that detects changes to the genes-the DNA instructions that are passed on from the mother and father. The results of a genetic test can confirm whether the participant has a genetic disorder, which is a disease caused in whole or in part by changes to the genes. Genetic testing can also help determine a person's chance of getting or passing on a genetic disorder. Genetic tests use a sample of blood, hair, skin, or other tissue, and they can look at one gene or multiple genes at the same time. Genetic testing may change the options for treating people with certain types of cancer. For example, some medications are more helpful for the treatment of cancer in people with certain gene changes (mutations).
The researchers are doing this study to develop new educational materials about genetic testing for people who speak different languages and have diverse cultural and educational backgrounds. During the study, the staff will interview participants with diverse cultural and educational backgrounds and ask them to review a sample of the educational materials that have been developed so far. Participants will give their opinions on these materials, and the researchers will use participants' feedback to improve the materials.
Detailed description
The objective of this proposal is to develop, test and evaluate a mainstreaming (LCAM) model for hereditary cancer multigene panel testing (MGPT) among many different types of cancer patients. The central hypothesis is that this LCAM genetic testing model will lead to better patient decision-making, psychosocial, and behavioral outcomes than a traditional model of genetic services represented by our standard-of-care arm. In Phase 1, the researchers will first conduct formative research including transcreation and cognitive interviewing to adapt our existing educational materials (brochure and video) and clinical communication materials (clinic visit summary and family dissemination messaging) for the LCAM model to be useful for patients of many different backgrounds. In Phase 2, the researchers will conduct a randomized clinical trial (RCT) to test and evaluate effects of the LCAM model for hereditary cancer MGPT as compared to standard-of-care among the patients treated at local community hospitals. Patients diagnosed with breast, colorectal, ovarian, pancreatic, or prostate cancer will be offered hereditary cancer MGPT through either: i) standard-of-care wherein in-depth pre-test and post-test genetic counseling are provided via telegenetics (videoconferencing), or ii) LCAM intervention wherein patients receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials. Participants will be followed prospectively and will complete assessments consisting of validated and investigator-designed measures. Phase 2 primary outcomes include genetic test decision satisfaction and genetic counseling satisfaction. Secondary outcomes include additional decision-making, psychosocial, and behavioral outcomes.
For Phase 2, participants will be recruited from our partnering sites, which include Kings County Hospital Center, Queens Cancer Center, Jamaica Hospital Medical Center, and the MSK Ralph Lauren Center for Cancer Care as well via referrals from underserved community sites through the MSK RLCCC network. Study staff will identify eligible patients from review of clinic lists and patient medical records, and will also receive direct study referrals from clinicians located at the partnering sites. Study staff will approach eligible patients in order to describe the study, screen them for eligibility (including assessing language proficiency via self-report and prior experience with cancer genetic counseling/testing), and obtain informed consent and collect their contact information.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive interview intervention for Phase 1 | Experimental | Other: Cognitive interviewThere is no treatment or intervention for Phase 1 of this study. Participants will be asked to participate in a cognitive interview. This section will be amended to include the Phase 2 intervention information once the Phase 1 portion of the study is complete. The Phase 1 materials developed, and results obtained, will directly be part of and inform the intervention for Phase 2.Phase 2: participants will be randomized to the standard-of-care arm or the LCAM intervention arm. |
| Standard of care (Phase II only randomization) | Active comparator | Behavioral: Standard of careParticipants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics |
| LCAM Intervention (Phase II only randomization) | Active comparator | Behavioral: LCAM interventionParticipants will receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Phase 1
- Age ≥ 18 years as per self-report
- Current or previous diagnosis of breast, ovarian, pancreatic, or prostate cancer as per self-report
- Self-identification as Black, Latino, and/or neither Black nor Latino (i.e.,non-Latino, Non black)
- Fluency in English, Haitian Creole, or Spanish as per self-report (for Spanish, we will attempt to recruit a cohort representing a variety of regions where Spanish is spoken, as informed by current data from participating sites, to achieve neutrality in the language) Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken and reading ability.
Key exclusion criteria (6 listed)
- Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment.
- Subjects who indicate level of fluency as "not at all" or "not well".
- Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment.
- Subjects who indicate level of fluency as "not at all" or "not well".
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 |
|---|---|---|
| Cognitive interviewResearchers will use formative methods to adapt our previously-developed mainstreaming pre-genetic test educational materials plus standard post-test clinical communication materials used by the MSK CGS for use with the diverse patients. Specifically, it will adapt these materials to be responsive to patients' linguistic and literacy needs, and sensitive to their cultural diversity. | Other | Cognitive interview intervention for Phase 1 |
| LCAM interventionParticipants will receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials. | Behavioural | LCAM Intervention (Phase II only randomization) |
| Standard of careParticipants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics | Behavioural | Standard of care (Phase II only randomization) |
Primary outcome
Number of patients who complete the cognitive interview (Phase I)
Time frame: 1 year
the number of patients who complete the cognitive interview
Genetic test decision (Phase II) satisfaction
Time frame: 6 months
is measured with the validated Satisfaction with Decisions scale.
Genetic counseling satisfaction (Phase II)
Time frame: 6 months
is measured with the validated Genetic Counseling Satisfaction scale
9 secondary outcomes
Test uptake (Phase II)
Time frame: 6 months
Knowledge (Phase II)
Time frame: 6 months
Empowerment (Phase II)
Time frame: 6 months
Distress (Phase II)
Time frame: 6 months
Concerns about genetic testing (Phase II)
Time frame: 6 months
Family communication (Phase II)
Time frame: 6 months
Family cascade testing (Phase II)
Time frame: 6 months
Intentions to adopt risk management behaviors (Phase II)
Time frame: 6 months
Long term engagement and understanding (Phase II)
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 5 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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.
Jennifer Hay, PhD contact
Jada Hamilton, PhD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive interview and LCAM intervention in people with Educational Materials for Genetic Testing and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites 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 24 inclusion and 6 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 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 4 sites 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 Jada Hamilton, PhD, MPH (646-888-0049, hamiltoj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who complete the cognitive interview (Phase I) (time frame: 1 year). 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 5 Oct 2026.