Hereditary Cancer SyndromeCHARMNCT03426878
Cancer Health Assessments Reaching Many
A study testing Modified genetic counseling and Traditional genetic counseling in people with Hereditary Cancer Syndrome, run by Kaiser Permanente at 2 sites in United States.
Trial summary
The CHARM (Cancer Health Assessment Reaching Many) study will assess the utility of clinical exome sequencing and how it affects care in diverse populations. The study population includes adults at risk for hereditary cancer syndromes. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Hereditary Cancer Syndrome
- What is being tested?
- Modified genetic counseling and Traditional genetic counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 967 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2018to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Kaiser Permanente Northwest or Denver Health patient
- Screens as high risk for a hereditary cancer syndrome via the risk assessment tool algorithms OR have unknown family history on either their mother or father's side of the family (or both)
- No known prior testing for familial mutations predisposing them to Lynch syndrome or hereditary breast and ovarian cancer
- English or Spanish speaker
Who cannot join
- Participant self-reported prior testing for Lynch syndrome (LS) or Hereditary Breast and Ovarian Cancer (HBOC) syndrome or identified as having previous comprehensive testing via Kaiser Permanente data files
- Not an English or Spanish speaker
- Unable to provide informed consent
- Don't want results placed in their medical record
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Denver Health
Denver, Colorado, 80204
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: Exome Sequencing in Diverse Populations in Colorado & Oregon
The CHARM (Cancer Health Assessment Reaching Many) study will assess the utility of clinical exome sequencing and how it affects care in diverse populations. The study population includes adults at risk for hereditary cancer syndromes.
The primary objective is to implement a hereditary cancer risk assessment program in healthy 18-49 year-olds in primary care settings within a vertically integrated health delivery system (Kaiser Permanente) and a federal qualified health center (Denver Health). The investigators will assess clinical exome sequencing implementation and interpretation, as well as tailored interactions for low health literacy including a contextualized consent process, and a modified approach to results disclosure and genetic counseling. The investigators will also assess the clinical utility (healthcare utilization and adherence to recommended care) and personal utility of primary and additional results from clinical exome sequencing, and evaluate the ethical and policy implications of considering personal utility of genomic information decisions for health care coverage.
Read the detailed description
Aim 1. Implement a hereditary cancer risk-assessment program in healthy 18-49-year-old adults in primary care settings, with stakeholder input, and offer exome sequencing to clarify risk.
Aim 1A. Identify and recruit 880 adult participants at-risk of a hereditary cancer syndrome.
Aim 1B: Generate medical exome sequence data and interpret variants. Aim 1C: Disclose findings from medical exome sequencing, incorporate results into the electronic medical record (EMR), and facilitate downstream patient management and coordination of care with the provider.
Aim 1D. Engage stakeholders to tailor and optimize the program in diverse populations.
Aim 2. Evaluate and tailor for diverse populations the critical interactions in the program, including the consent process, choices for reporting additional findings, and the response to results disclosure.
Aim 2A. Design, implement, and assess a contextualized consent process to support informed decision-making about participation in research about medical exome sequencing.
Aim 2B. Design, implement, and compare a novel decision aid in the second half of the study for selecting the optional categories of additional findings with the approach we developed in CSER1 that offered a category checklist.
Aim 2C. Design, implement, and compare a modified (communication-focused) approach to results disclosure, genetic counseling, and decision making with a standard (information-focused) approach.
Aim 3. Evaluate the clinical utility (including personal utility) of using exome sequencing to diagnose individuals with hereditary cancer syndromes and provide additional findings.
Aim 3A: Measure the yield of reportable findings for hereditary cancer syndromes and additional findings.
Aim 3B: Evaluate subsequent healthcare utilization for all study participants and adherence to recommended care among individuals who are identified with a hereditary cancer syndrome in diverse settings.
Aim 3C. Assess the personal utility of exome sequencing, including primary and additional findings.
Aim 4. Address pragmatic and ethical challenges to the integration of genomic medicine into clinical and health systems decision-making.
Aim 4A: Develop and pilot a system that integrates genomic, clinical, and healthcare utilization data to inform clinicians and patients acting on genomic information and to reduce care gaps in patient management.
Aim 4B: Advance the analysis of the ethical and policy implications of incorporating personal utility of genomic information into the decision framework for healthcare coverage.
- Conditions
- Hereditary Cancer Syndrome
- Being tested
- Modified genetic counseling, Traditional genetic counseling
- Keywords
- Lynch syndrome, Hereditary breast and ovarian cancer
- Medical subject headings
- Neoplastic Syndromes, Hereditary, Colorectal Neoplasms, Hereditary Nonpolyposis, Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified genetic counselingOther
After participants at high risk for a hereditary cancer syndrome receive exome sequencing, they will receive modified genetic counseling to help them understand the results.
Traditional genetic counselingOther
After participants at high risk for a hereditary cancer syndrome receive exome sequencing, they will receive traditional genetic counseling to help them understand the results.
| Study group | Role | What they receive |
|---|---|---|
| Traditional genetic counseling | Active comparator | This will be typical genetic counseling that a patient would receive in a traditional genetic counseling setting. Receives: Other: Traditional genetic counseling |
| Modified genetic counseling | Experimental | This will be genetic counseling that is modified for a lower literacy patient and will include fewer technical terms and less complicated genetic information. Receives: Other: Modified genetic counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Findings for Hereditary Cancer Syndromes
Number of people found to have a pathogenic (P) or likely pathogenic (LP) variant in one of the cancer genes associated with Lynch syndrome or hereditary breast and ovarian cancer
Measured: For each person, the test result was available within approximately one month of the receipt of that person's specimen at the laboratory.
Secondary outcomes (8)
Positive Findings for Other Medically Actionable Genetic Conditions
Number of people with pathogenic variants found in genes related to medically actionable hereditary conditions (other than cancer)
Measured: For each person, the test result was available within approximately one month of the receipt of that person's specimen at the laboratory.
Positive Findings for a Selected List of Carrier Conditions
Number of people with pathogenic variants found in genes related to common carrier conditions
Measured: For each person, the test result was available within approximately one month of the receipt of that person's specimen at the laboratory.
Number of Participants With Healthcare Utilization Measured Via Electronic Medical Record (EMR) Data
Downstream healthcare utilization of specific recommended procedures (e.g., colonoscopy, mammography, surgery) will be compared between CHARM participants who received at least one actionable risk management recommendation from study genetic counselors and those who did not receive an actionable risk management recommendation.
Measured: Within 12 months of participant receiving information about their hereditary cancer syndrome risk
Participant Understanding of Recommended Care
Measurement of participant's understanding of the recommended care based on their genetic test result will be assessed using a validated survey tool
Measured: 2 weeks post result disclosure, 6 months post result disclosure
Participant Understanding of Genetic Test Results
"Perceived understanding of results" This novel 5-item measure asked, "Thinking about only your cancer genetic test result, please rate how strongly you agree or disagree with each of the following statements." The 5 items were assessed on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). A principal-axis factor analysis strongly supported a 1 factor solution (accounting for 65.4% of the variance in these items), providing evidence for structural validity, and a Cronbach's α of 0.90, providing strong evidence for internal consistency. The scale was scored using the mean; thus, the possible scores can range from 1 to 5, with higher scores indicating greater understanding.
Measured: 2 weeks post genetic result disclosure
Participant Satisfaction of Genetic Counseling
This novel measure consisted of 4 items adapted from the Patient Assessment of Communication Effectiveness scale, 8 items developed by the consortium related to participants' overall satisfaction with the results and experience of results disclosures, and 6 items that focused on key elements of modified genetic counseling. Items were measured on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Using principal-axis factor analyses using oblique rotation, we found the 3-factor solution (accounting for 62.5% of the variance in the items) to provide adequate simple structure with conceptually meaningful factors and thus, created subscale scores for each set of items (6 loaded on each factor): "genetic counseling relationship score", "communication difficulty score", and "communication ease score". The possible mean scores can range from 1 to 5, with higher scores indicating a better outcome.
Measured: 2 weeks post genetic results disclosure
Family Communication
Measurement of the degree to which participants shared their genetic test results with various family members will be assessed using a validated survey tool
Measured: Assessed 6 months post result disclosure
Personal Utility of Genomic Sequencing (Qualitative Interview Only)
Participant's perceived utility of obtaining genetic testing and genetic counseling were assessed. Data collection used semi-structured qualitative interviews. Analyses were conducted using a modified grounded theory approach and explored the five utility domains of the model: clinical, emotional, behavioral, cognitive, and social. The analysis examined how well this multifaceted perceived utility model applied to the responses provided during the interviews. The qualitative data was not quantified in any way and can not be represented in a tabular format.
Measured: Qualitative interviews were conducted within 1 month of results disclosure; a subset of these participants were interviewed again at 6 months post-results disclosure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start15 Aug 2018
- Primary completion20 Aug 2020
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hereditary Cancer SyndromeStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will receive exome sequencing. The randomization will be into one of two types of genetic counseling - traditional and modified.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 967 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), University of Washington, Seattle Children's Hospital, University of California, San Francisco, Denver Health and Hospital Authority, Emory University, Dana-Farber Cancer Institute, Columbia University
- Responsible party
- Sponsor
- Investigators
- Michael Leo, PhD, Principal investigator, Center for Health Research, Kaiser Permanente NorthwestBenjamin S Wilfond, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426878
- Sponsor's protocol ID
- 2U01HG007292-05
- Other IDs
- 2U01HG007292-05
- Acronym
- CHARM
- Status last verified
- Mar 2025
- First submitted
- 11 Jan 2018
- Last updated
- 11 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Genotype and Phenotype data will be uploaded to ANVIL. Variant data will be uploaded to ClinVar.
Publications
Okuyama S, White LL, Anderson KP, Medina E, Deutsch S, Ransom C, Jackson P, Kauffman TL, Mittendorf KF, Leo MC, Bulkley JE, Wilfond BS, Goddard KA, Feigelson HS. Evaluating cancer genetic services in a safety net system: overcoming barriers for a lasting impact beyond the CHARM research project. J Community Genet. 2023 Jun;14(3):329-336. doi: 10.1007/s12687-023-00647-x. Epub 2023 May 1.
PubMed 37126135Mittendorf KF, Lewis HS, Duenas DM, Eubanks DJ, Gilmore MJ, Goddard KAB, Joseph G, Kauffman TL, Kraft SA, Lindberg NM, Reyes AA, Shuster E, Syngal S, Ukaegbu C, Zepp JM, Wilfond BS, Porter KM. Literacy-adapted, electronic family history assessment for genetics referral in primary care: patient user insights from qualitative interviews. Hered Cancer Clin Pract. 2022 Jun 10;20(1):22. doi: 10.1186/s13053-022-00231-3.
PubMed 35689290Mittendorf KF, Kauffman TL, Amendola LM, Anderson KP, Biesecker BB, Dorschner MO, Duenas DM, Eubanks DJ, Feigelson HS, Gilmore MJ, Hunter JE, Joseph G, Kraft SA, Lee SSJ, Leo MC, Liles EG, Lindberg NM, Muessig KR, Okuyama S, Porter KM, Riddle LS, Rolf BA, Rope AF, Zepp JM, Jarvik GP, Wilfond BS, Goddard KAB; CHARM study team. Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations. Contemp Clin Trials. 2021 Jul;106:106432. doi: 10.1016/j.cct.2021.106432. Epub 2021 May 11.
PubMed 33984519
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exome Sequencing in Diverse Populations in Colorado & Oregon
- ClinicalTrials.gov ID
- NCT03426878
- Acronym / sponsor ID
- CHARM / 2U01HG007292-05
- Conditions
- Hereditary Cancer Syndrome
- Keywords
- Lynch syndrome, Hereditary breast and ovarian cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 967 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), University of Washington, Seattle Children's Hospital, University of California, San Francisco, Denver Health and Hospital Authority, Emory University, Dana-Farber Cancer Institute, Columbia University
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CHARM (Cancer Health Assessment Reaching Many) study will assess the utility of clinical exome sequencing and how it affects care in diverse populations. The study population includes adults at risk for hereditary cancer syndromes.
The primary objective is to implement a hereditary cancer risk assessment program in healthy 18-49 year-olds in primary care settings within a vertically integrated health delivery system (Kaiser Permanente) and a federal qualified health center (Denver Health). The investigators will assess clinical exome sequencing implementation and interpretation, as well as tailored interactions for low health literacy including a contextualized consent process, and a modified approach to results disclosure and genetic counseling. The investigators will also assess the clinical utility (healthcare utilization and adherence to recommended care) and personal utility of primary and additional results from clinical exome sequencing, and evaluate the ethical and policy implications of considering personal utility of genomic information decisions for health care coverage.
Detailed description
Aim 1. Implement a hereditary cancer risk-assessment program in healthy 18-49-year-old adults in primary care settings, with stakeholder input, and offer exome sequencing to clarify risk.
Aim 1A. Identify and recruit 880 adult participants at-risk of a hereditary cancer syndrome.
Aim 1B: Generate medical exome sequence data and interpret variants. Aim 1C: Disclose findings from medical exome sequencing, incorporate results into the electronic medical record (EMR), and facilitate downstream patient management and coordination of care with the provider.
Aim 1D. Engage stakeholders to tailor and optimize the program in diverse populations.
Aim 2. Evaluate and tailor for diverse populations the critical interactions in the program, including the consent process, choices for reporting additional findings, and the response to results disclosure.
Aim 2A. Design, implement, and assess a contextualized consent process to support informed decision-making about participation in research about medical exome sequencing.
Aim 2B. Design, implement, and compare a novel decision aid in the second half of the study for selecting the optional categories of additional findings with the approach we developed in CSER1 that offered a category checklist.
Aim 2C. Design, implement, and compare a modified (communication-focused) approach to results disclosure, genetic counseling, and decision making with a standard (information-focused) approach.
Aim 3. Evaluate the clinical utility (including personal utility) of using exome sequencing to diagnose individuals with hereditary cancer syndromes and provide additional findings.
Aim 3A: Measure the yield of reportable findings for hereditary cancer syndromes and additional findings.
Aim 3B: Evaluate subsequent healthcare utilization for all study participants and adherence to recommended care among individuals who are identified with a hereditary cancer syndrome in diverse settings.
Aim 3C. Assess the personal utility of exome sequencing, including primary and additional findings.
Aim 4. Address pragmatic and ethical challenges to the integration of genomic medicine into clinical and health systems decision-making.
Aim 4A: Develop and pilot a system that integrates genomic, clinical, and healthcare utilization data to inform clinicians and patients acting on genomic information and to reduce care gaps in patient management.
Aim 4B: Advance the analysis of the ethical and policy implications of incorporating personal utility of genomic information into the decision framework for healthcare coverage.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants will receive exome sequencing. The randomization will be into one of two types of genetic counseling - traditional and modified.
| Arm | Type | Receives |
|---|---|---|
| Traditional genetic counseling | Active comparator | Other: Traditional genetic counselingThis will be typical genetic counseling that a patient would receive in a traditional genetic counseling setting. |
| Modified genetic counseling | Experimental | Other: Modified genetic counselingThis will be genetic counseling that is modified for a lower literacy patient and will include fewer technical terms and less complicated genetic information. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Kaiser Permanente Northwest or Denver Health patient
- Screens as high risk for a hereditary cancer syndrome via the risk assessment tool algorithms OR have unknown family history on either their mother or father's side of the family (or both)
- No known prior testing for familial mutations predisposing them to Lynch syndrome or hereditary breast and ovarian cancer
- English or Spanish speaker
Key exclusion criteria (4 listed)
- Participant self-reported prior testing for Lynch syndrome (LS) or Hereditary Breast and Ovarian Cancer (HBOC) syndrome or identified as having previous comprehensive testing via Kaiser Permanente data files
- Not an English or Spanish speaker
- Unable to provide informed consent
- Don't want results placed in their medical record
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 |
|---|---|---|
| Modified genetic counselingAfter participants at high risk for a hereditary cancer syndrome receive exome sequencing, they will receive modified genetic counseling to help them understand the results. | Other | Modified genetic counseling |
| Traditional genetic counselingAfter participants at high risk for a hereditary cancer syndrome receive exome sequencing, they will receive traditional genetic counseling to help them understand the results. | Other | Traditional genetic counseling |
Primary outcome
Positive Findings for Hereditary Cancer Syndromes
Time frame: For each person, the test result was available within approximately one month of the receipt of that person's specimen at the laboratory.
Number of people found to have a pathogenic (P) or likely pathogenic (LP) variant in one of the cancer genes associated with Lynch syndrome or hereditary breast and ovarian cancer
8 secondary outcomes
Positive Findings for Other Medically Actionable Genetic Conditions
Time frame: For each person, the test result was available within approximately one month of the receipt of that person's specimen at the laboratory.
Positive Findings for a Selected List of Carrier Conditions
Time frame: For each person, the test result was available within approximately one month of the receipt of that person's specimen at the laboratory.
Number of Participants With Healthcare Utilization Measured Via Electronic Medical Record (EMR) Data
Time frame: Within 12 months of participant receiving information about their hereditary cancer syndrome risk
Participant Understanding of Recommended Care
Time frame: 2 weeks post result disclosure, 6 months post result disclosure
Participant Understanding of Genetic Test Results
Time frame: 2 weeks post genetic result disclosure
Participant Satisfaction of Genetic Counseling
Time frame: 2 weeks post genetic results disclosure
Family Communication
Time frame: Assessed 6 months post result disclosure
Personal Utility of Genomic Sequencing (Qualitative Interview Only)
Time frame: Qualitative interviews were conducted within 1 month of results disclosure; a subset of these participants were interviewed again at 6 months post-results disclosure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37126135Okuyama S, White LL, Anderson KP, Medina E, Deutsch S, Ransom C, Jackson P, Kauffman TL, Mittendorf KF, Leo MC, Bulkley JE, Wilfond BS, Goddard KA, Feigelson HS. Evaluating cancer genetic services in a safety net system: overcoming barriers for a lasting impact beyond the CHARM research project. J Community Genet. 2023 Jun;14(3):329-336. doi: 10.1007/s12687-023-00647-x. Epub 2023 May 1.
- Derived from this study: PubMed 35689290Mittendorf KF, Lewis HS, Duenas DM, Eubanks DJ, Gilmore MJ, Goddard KAB, Joseph G, Kauffman TL, Kraft SA, Lindberg NM, Reyes AA, Shuster E, Syngal S, Ukaegbu C, Zepp JM, Wilfond BS, Porter KM. Literacy-adapted, electronic family history assessment for genetics referral in primary care: patient user insights from qualitative interviews. Hered Cancer Clin Pract. 2022 Jun 10;20(1):22. doi: 10.1186/s13053-022-00231-3.
- Derived from this study: PubMed 33984519Mittendorf KF, Kauffman TL, Amendola LM, Anderson KP, Biesecker BB, Dorschner MO, Duenas DM, Eubanks DJ, Feigelson HS, Gilmore MJ, Hunter JE, Joseph G, Kraft SA, Lee SSJ, Leo MC, Liles EG, Lindberg NM, Muessig KR, Okuyama S, Porter KM, Riddle LS, Rolf BA, Rope AF, Zepp JM, Jarvik GP, Wilfond BS, Goddard KAB; CHARM study team. Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations. Contemp Clin Trials. 2021 Jul;106:106432. doi: 10.1016/j.cct.2021.106432. Epub 2021 May 11.
- Individual participant dataSharing planned: Yes. Genotype and Phenotype data will be uploaded to ANVIL. Variant data will be uploaded to ClinVar.
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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.
Michael Leo, PhD principal investigator
Center for Health Research, Kaiser Permanente Northwest
Benjamin S Wilfond, MD principal investigator
Seattle Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified genetic counseling and Traditional genetic counseling in people with Hereditary Cancer Syndrome, run by Kaiser Permanente at 2 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 4 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Positive Findings for Hereditary Cancer Syndromes (time frame: For each person, the test result was available within approximately one month of the receipt of that person's specimen at the laboratory.). 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 NCT03426878, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.