Pediatric CancerNCT04848142
Psychosocial Impact of Disclosing Cancer Predisposition Genetic Testing Results During Childhood
An observational study of Pediatric Cancer and Predisposition, Genetic, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The participants are being asked to take part in this research study because the participant is a child who has been diagnosed with cancer and has completed genetic testing to find out if the participant has a variant in a gene that may predispose the participant to cancer, and/or the participants are the parents… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Pediatric Cancer, Predisposition, Genetic
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2021to 13 Oct 2023
- Phase
- Observational
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.
Who may be able to join
- Primary Strata
- Patient underwent germline genetic testing as offered through the SJCRH Cancer Predisposition Program with results disclosed to patient and/or parents (i.e., of testing results are not a criterion for eligibility)
- Patient's age at the time of initial germline result disclosure was birth - 17 years of age (inclusive)
- Patient had diagnosis of malignancy (or benign tumor; e.g., craniopharyngioma) prior to germline testing
- A parent/legal guardian/caregiver is willing to participate in the research study and provide consent
- Participant family is fluent in English for completion of questionnaires (able to speak and read)
Show all 14Show fewer
- Patient is currently 8 years of age or older
- Parent Only Strata
- Parent (i.e., guardian/caregiver) of a patient who underwent germline genetic testing as offered through the SJCRH Cancer Predisposition Program with results disclosed to patient and/or parents 1 - 3 years (inclusive) previously (Note- patient's knowledge of testing results are not a criterion for eligibility)
- Parent of a patient whose age at the time of initial germline result disclosure was birth - 17 years of age (inclusive)
- Parent of a patient with a diagnosis of malignancy (or benign tumor; e.g., craniopharyngioma) prior to germline testing
- Parent/caregiver is a legal guardian willing to participate in the research study and provide consent
- Participant family is fluent in English for completion of questionnaires (able to speak and read).
- Parent of a patient currently younger than 8 years of age.
Who cannot join
- Inability or unwillingness of research participant or parent (i.e., guardian/caregiver) to give informed consent
- Parent is under the age of 18 years
- Parent has evidence of significant cognitive deficits (per medical report) that would interfere with the ability to comprehend questionnaires
- Research participant's medical status or condition precludes completion of the study (as determined by the medical team, patient, or parent)
Trial locations and contacts
1 site in 1 country.
United States1 site
St.Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
The participants are being asked to take part in this research study because the participant is a child who has been diagnosed with cancer and has completed genetic testing to find out if the participant has a variant in a gene that may predispose the participant to cancer, and/or the participants are the parents (i.e., guardian/caregiver) of this child. This research is being done to understand how finding out the results of genetic testing during childhood impacts the participant and family. The investigator will compare the emotions and behavior of parents and children based on the genetic testing results.
Primary Objective
Read more
- Examine the impact of genetic testing result disclosure for a pathogenic (P)/likely pathogenic (LP) germline variant in a known cancer predisposing gene versus negative results on parent adjustment (i.e., emotional functioning, cancer worry, symptom interpretation, and genetic testing related worry/distress).
- Examine the impact of genetic testing result disclosure for a P/LP germline variant versus negative results on parenting (i.e., responses to children's symptoms, overprotectiveness, parent-child communication, cohesion, and expressivity in the family).
Exploratory Objectives
- Examine the impact of genetic testing result disclosure (P/LP versus negative results) on child adjustment (i.e. emotional functioning, cancer worry, self-perception, and life meaning and purpose).
- Examine the impact of disclosing a variant of uncertain significance (VUS) on parent adjustment, parenting, and child adjustment.
- Examine the indirect association between genetic testing result disclosure (P/LP versus negative results) and child adjustment through parental adjustment and parenting behavior.
- Qualitatively identify children and parents' perspectives of how disclosure of a cancer predisposition has affected children's emotional, social, personal, and familial functioning.
Read the detailed description
A mixed methods approach, including questionnaires and qualitative interviews with children and their parents. Participants ("Primary Strata:" parents (i.e., guardians/caregivers) and children age ≥ 8 years, n=132; "Parent Only Strata:" parents of children age < 8 years, n=66) will complete questionnaires to examine the impact of germline variant disclosure on parent adjustment, parenting, and child adjustment. Optional qualitative interviews may be completed individually for participants (age ≥ 12 years, n=30) with P/LP variants (and who are aware of their result status) and their parents (n=30) to obtain more open-ended information about the impact of genetic testing result disclosure, family communication about testing results, and their perception of result implications.
- Conditions
- Pediatric Cancer, Predisposition, Genetic
- Medical subject headings
- Neoplasms, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Group (parent-child) | parents (i.e., guardians/caregivers) and children age ≥ 8 years,will complete questionnaires to examine the impact of germline variant disclosure on parent adjustment, parenting, and child adjustment. Optional qualitative interviews may be completed individually for participants (age ≥ 12 years with P/LP variant and aware of results, or their parent) | |
| Parent Only Group | parents of children age < 8 years, will complete questionnaires to examine the impact of germline variant disclosure on parent adjustment, parenting, and child adjustment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Cancer Recurrence
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Fear of Cancer Recurrence - Short Form. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Cancer Information Questionnaire for Parents
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the Cancer Information Questionnaire for Parents. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Multidimensional Impact of Cancer Risk Assessment
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Multidimensional Impact of Cancer Risk Assessment. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Brief Symptom Inventory 18
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Brief Symptom Inventory 18. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Impact of Event Scale
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Impact of Event Scale - Revised. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Psychological Adaptation to Genetic Information Scale
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Psychological Adaptation to Genetic Information Scale-Modified. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Symptom Interpretation Questionnaire-Parent Report
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the Symptom Interpretation Questionnaire-Parent Report. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Parent-Adolescent Communication Scale
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) of parent- and child-reports on the Parent-Adolescent Communication Scale. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Family Environment Scale
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Family Environment Scale-Revised. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Parental Bonding Instrument
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the child-reported Parental Bonding Instrument. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Parent Protection Scale
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Parent Protection Scale. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Openness to Discuss Cancer in the Family
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Openness to Discuss Cancer in the Family. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Child Vulnerability Scale
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Child Vulnerability Scale. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Adult Responses to Children's Symptoms
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Adult Responses to Children's Symptoms. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start7 May 2021
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
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 Pediatric CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katianne Sharp, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848142
- Sponsor's protocol ID
- PSYGEN
- Status last verified
- Oct 2023
- First submitted
- 12 Apr 2021
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Howard Sharp KM, Blake A, Humphrey C, Flynn JS, Harrison L, McGee RB, Mandrell BN, Nichols KE. A Qualitative Analysis of Parent-AYA Communication About Cancer Predisposition Diagnosed During Pediatric Cancer Care. Pediatr Blood Cancer. 2026 Jul 25:e70530. doi: 10.1002/1545-5017.70530. Online ahead of print.
PubMed 42499274
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Impact of Disclosing Cancer Predisposition Genetic Testing Results During Childhood
- ClinicalTrials.gov ID
- NCT04848142
- Acronym / sponsor ID
- PSYGEN
- Conditions
- Pediatric Cancer, Predisposition, Genetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 19 Apr 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.
The participants are being asked to take part in this research study because the participant is a child who has been diagnosed with cancer and has completed genetic testing to find out if the participant has a variant in a gene that may predispose the participant to cancer, and/or the participants are the parents (i.e., guardian/caregiver) of this child. This research is being done to understand how finding out the results of genetic testing during childhood impacts the participant and family. The investigator will compare the emotions and behavior of parents and children based on the genetic testing results.
Primary Objective
- Examine the impact of genetic testing result disclosure for a pathogenic (P)/likely pathogenic (LP) germline variant in a known cancer predisposing gene versus negative results on parent adjustment (i.e., emotional functioning, cancer worry, symptom interpretation, and genetic testing related worry/distress).
- Examine the impact of genetic testing result disclosure for a P/LP germline variant versus negative results on parenting (i.e., responses to children's symptoms, overprotectiveness, parent-child communication, cohesion, and expressivity in the family).
Exploratory Objectives
- Examine the impact of genetic testing result disclosure (P/LP versus negative results) on child adjustment (i.e. emotional functioning, cancer worry, self-perception, and life meaning and purpose).
- Examine the impact of disclosing a variant of uncertain significance (VUS) on parent adjustment, parenting, and child adjustment.
- Examine the indirect association between genetic testing result disclosure (P/LP versus negative results) and child adjustment through parental adjustment and parenting behavior.
- Qualitatively identify children and parents' perspectives of how disclosure of a cancer predisposition has affected children's emotional, social, personal, and familial functioning.
Detailed description
A mixed methods approach, including questionnaires and qualitative interviews with children and their parents. Participants ("Primary Strata:" parents (i.e., guardians/caregivers) and children age ≥ 8 years, n=132; "Parent Only Strata:" parents of children age < 8 years, n=66) will complete questionnaires to examine the impact of germline variant disclosure on parent adjustment, parenting, and child adjustment. Optional qualitative interviews may be completed individually for participants (age ≥ 12 years, n=30) with P/LP variants (and who are aware of their result status) and their parents (n=30) to obtain more open-ended information about the impact of genetic testing result disclosure, family communication about testing results, and their perception of result implications.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Group (parent-child) | – | –parents (i.e., guardians/caregivers) and children age ≥ 8 years,will complete questionnaires to examine the impact of germline variant disclosure on parent adjustment, parenting, and child adjustment. Optional qualitative interviews may be completed individually for participants (age ≥ 12 years with P/LP variant and aware of results, or their parent) |
| Parent Only Group | – | –parents of children age < 8 years, will complete questionnaires to examine the impact of germline variant disclosure on parent adjustment, parenting, and child adjustment. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants who meet eligibility criteria and consent to enrollment on the study.
Key inclusion criteria (14 listed)
- Primary Strata
- Patient underwent germline genetic testing as offered through the SJCRH Cancer Predisposition Program with results disclosed to patient and/or parents (i.e., of testing results are not a criterion for eligibility)
- Patient's age at the time of initial germline result disclosure was birth - 17 years of age (inclusive)
- Patient had diagnosis of malignancy (or benign tumor; e.g., craniopharyngioma) prior to germline testing
- A parent/legal guardian/caregiver is willing to participate in the research study and provide consent
Key exclusion criteria (4 listed)
- Inability or unwillingness of research participant or parent (i.e., guardian/caregiver) to give informed consent
- Parent is under the age of 18 years
- Parent has evidence of significant cognitive deficits (per medical report) that would interfere with the ability to comprehend questionnaires
- Research participant's medical status or condition precludes completion of the study (as determined by the medical team, patient, or parent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fear of Cancer Recurrence
Time frame: Day 0
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Fear of Cancer Recurrence - Short Form. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Cancer Information Questionnaire for Parents
Time frame: Day 0
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the Cancer Information Questionnaire for Parents. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Multidimensional Impact of Cancer Risk Assessment
Time frame: Day 0
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Multidimensional Impact of Cancer Risk Assessment. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Brief Symptom Inventory 18
Time frame: Day 0
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Brief Symptom Inventory 18. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Impact of Event Scale
Time frame: Day 0
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Impact of Event Scale - Revised. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Psychological Adaptation to Genetic Information Scale
Time frame: Day 0
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Psychological Adaptation to Genetic Information Scale-Modified. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Symptom Interpretation Questionnaire-Parent Report
Time frame: Day 0
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the Symptom Interpretation Questionnaire-Parent Report. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Parent-Adolescent Communication Scale
Time frame: Day 0
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) of parent- and child-reports on the Parent-Adolescent Communication Scale. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Family Environment Scale
Time frame: Day 0
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Family Environment Scale-Revised. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Parental Bonding Instrument
Time frame: Day 0
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the child-reported Parental Bonding Instrument. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Parent Protection Scale
Time frame: Day 0
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Parent Protection Scale. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Openness to Discuss Cancer in the Family
Time frame: Day 0
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Openness to Discuss Cancer in the Family. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Child Vulnerability Scale
Time frame: Day 0
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Child Vulnerability Scale. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Adult Responses to Children's Symptoms
Time frame: Day 0
Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Adult Responses to Children's Symptoms. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
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 18 Oct 2023.
- Derived from this study: PubMed 42499274Howard Sharp KM, Blake A, Humphrey C, Flynn JS, Harrison L, McGee RB, Mandrell BN, Nichols KE. A Qualitative Analysis of Parent-AYA Communication About Cancer Predisposition Diagnosed During Pediatric Cancer Care. Pediatr Blood Cancer. 2026 Jul 25:e70530. doi: 10.1002/1545-5017.70530. Online ahead of print.
- St.Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Katianne Sharp, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer and Predisposition, Genetic, run by St. Jude Children's Research Hospital 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 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: finished, as of the sponsor's last update on 18 Oct 2023. 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?
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?
Fear of Cancer Recurrence (time frame: Day 0). The study lists 14 primary outcomes in all. 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 NCT04848142, 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 18 Oct 2023.