Hematopoietic and Lymphatic System NeoplasmNCT06569316
Genetic Testing for the Prevention of Cancer in American Indian Communities (JUNIPER Trial)
A study testing Biospecimen Collection, Communication Intervention and Genetic Testing in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial is studying the genetic changes in cells associated with different types of cancer in American Indian (AI) populations in the Southwest to improve cancer screening, precision prevention, and therapeutic intervention for individual in these communities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Biospecimen Collection, Communication Intervention and Genetic Testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to 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
- Male or female adults >= 18 years of age
- Cancer patient undergoing active treatment or a cancer survivor
- Self-identify as American Indian
Who cannot join
- Unable to provide informed consent
- Individuals who are under 18 years of age
- Prisoners
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
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Jewel Samadder, MD
About this study
Official title: Journey to Understanding - American Indian Peoples Engagement in Cancer Research Arizona (JUNIPER)
This clinical trial is studying the genetic changes in cells associated with different types of cancer in American Indian (AI) populations in the Southwest to improve cancer screening, precision prevention, and therapeutic intervention for individual in these communities. AI tribes have much lower rates of cancer screening, have more limited access to healthcare, are more often diagnosed at later stages of disease, and have the poorest outcomes in all types of cancer when compared to any other racial and ethnic group in the United States. Due to these significant cancer health disparities, AIs have been understudied and little is known about the molecular characterization of tumors arising in AIs. Undergoing genetic testing of tumors may improve cancer outcomes in AI participants and communities.
Read the detailed description
PRIMARY OBJECTIVES:
- To develop culturally appropriate, respectful, trusted, and collaborative means to engage and recruit American Indians (AIs) affected by cancer (newly diagnosed cancer participants, participants undergoing cancer treatment, and cancer survivors) for molecular characterization of their tumors.
Ia. Conduct direct participant engagement with cancer participants/survivors, community advisors, and partners to refine and optimize methods/processes.
Ib. Identify, recruit, and consent eligible AI cancer participants/survivors. Ic. Implement tissue acquisition, epidemiologic, behavioral, and clinical data collection, conduct continuous assessment of performance benchmarks.
Id. Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select.
Ie. To further understand microbiome diversity alterations associated with tumor initiation, progression, and response to therapy.
SECONDARY OBJECTIVES:
- Translate any discoveries to improved cancer screening, precision prevention, and therapeutic intervention that can be used to enhance cancer screening and precision prevention and improve cancer outcomes in American Indian participants and communities.
II. Determine if microbiome sequencing will elucidate compositions and diversity distinct to these understudied cohorts, and that these microbiome alterations will offer novel diagnostic and therapeutic avenues in these patients.
OUTLINE:
Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from standard of care (SOC) surgical procedure or biopsy, or stored tissue samples for genetic testing as well as mouthwash saliva samples on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
After completion of study intervention, patients are followed up once a year up to 5 years from study registration.
- Being tested
- Biospecimen Collection, Communication Intervention, Genetic Testing, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection, Sample Collection
Undergo blood or saliva, leftover tissue, and mouthwash saliva sample collection
Communication InterventionOther
Receive care plan recommendations
Genetic TestingOther
Also called Genetic Analysis, Genetic Examination, Genetic Test
Undergo genetic testing
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Screening (blood, saliva, tissue collection, genetic testing) | Experimental | Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing as well as mouthwash saliva samples on study. Patients receive the results of their genetic testing and are given resources for counseling and further care. Receives: Procedure: Biospecimen Collection; Other: Communication Intervention; Other: Genetic Testing; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful accrual of American Indian (AI) participants
Assessed by the number of AI participants consented to study.
Measured: Up to 5 years
Return of valuable genetic results to participants
Assessed by the number of participants who receive genetic results. Clinically useful genomic data will be returned to participants with navigation to counseling and clinical resources as warranted and as they select.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start27 Sep 2024
- 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 Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jewel Samadder, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569316
- Sponsor's protocol ID
- MC240902
- Other IDs
- U2CCA252973, 24-006285
- Status last verified
- Jul 2026
- First submitted
- 22 Aug 2024
- Last updated
- 29 Jul 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Journey to Understanding - American Indian Peoples Engagement in Cancer Research Arizona (JUNIPER)
- ClinicalTrials.gov ID
- NCT06569316
- Acronym / sponsor ID
- MC240902
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Aug 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.
This clinical trial is studying the genetic changes in cells associated with different types of cancer in American Indian (AI) populations in the Southwest to improve cancer screening, precision prevention, and therapeutic intervention for individual in these communities. AI tribes have much lower rates of cancer screening, have more limited access to healthcare, are more often diagnosed at later stages of disease, and have the poorest outcomes in all types of cancer when compared to any other racial and ethnic group in the United States. Due to these significant cancer health disparities, AIs have been understudied and little is known about the molecular characterization of tumors arising in AIs. Undergoing genetic testing of tumors may improve cancer outcomes in AI participants and communities.
Detailed description
PRIMARY OBJECTIVES:
- To develop culturally appropriate, respectful, trusted, and collaborative means to engage and recruit American Indians (AIs) affected by cancer (newly diagnosed cancer participants, participants undergoing cancer treatment, and cancer survivors) for molecular characterization of their tumors.
Ia. Conduct direct participant engagement with cancer participants/survivors, community advisors, and partners to refine and optimize methods/processes.
Ib. Identify, recruit, and consent eligible AI cancer participants/survivors. Ic. Implement tissue acquisition, epidemiologic, behavioral, and clinical data collection, conduct continuous assessment of performance benchmarks.
Id. Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select.
Ie. To further understand microbiome diversity alterations associated with tumor initiation, progression, and response to therapy.
SECONDARY OBJECTIVES:
- Translate any discoveries to improved cancer screening, precision prevention, and therapeutic intervention that can be used to enhance cancer screening and precision prevention and improve cancer outcomes in American Indian participants and communities.
II. Determine if microbiome sequencing will elucidate compositions and diversity distinct to these understudied cohorts, and that these microbiome alterations will offer novel diagnostic and therapeutic avenues in these patients.
OUTLINE:
Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from standard of care (SOC) surgical procedure or biopsy, or stored tissue samples for genetic testing as well as mouthwash saliva samples on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
After completion of study intervention, patients are followed up once a year up to 5 years from study registration.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (blood, saliva, tissue collection, genetic testing) | Experimental | Procedure: Biospecimen Collection, Other: Communication Intervention, Other: Genetic Testing, Other: Survey AdministrationPatients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing as well as mouthwash saliva samples on study. Patients receive the results of their genetic testing and are given resources for counseling and further care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adults >= 18 years of age
- Cancer patient undergoing active treatment or a cancer survivor
- Self-identify as American Indian
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Individuals who are under 18 years of age
- Prisoners
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen Collection, Sample CollectionUndergo blood or saliva, leftover tissue, and mouthwash saliva sample collection | Procedure or surgery | Screening (blood, saliva, tissue collection, genetic testing) |
| Communication InterventionReceive care plan recommendations | Other | Screening (blood, saliva, tissue collection, genetic testing) |
| Genetic TestingAlso: Genetic Analysis, Genetic Examination, Genetic TestUndergo genetic testing | Other | Screening (blood, saliva, tissue collection, genetic testing) |
| Survey AdministrationAncillary studies | Other | Screening (blood, saliva, tissue collection, genetic testing) |
Primary outcome
Successful accrual of American Indian (AI) participants
Time frame: Up to 5 years
Assessed by the number of AI participants consented to study.
Return of valuable genetic results to participants
Time frame: Up to 5 years
Assessed by the number of participants who receive genetic results. Clinically useful genomic data will be returned to participants with navigation to counseling and clinical resources as warranted and as they select.
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 29 Jul 2026.
- Mayo Clinic Clinical TrialsLink 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.
Jewel Samadder, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Communication Intervention and Genetic Testing in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic 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 3 inclusion and 3 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 29 Jul 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful accrual of American Indian (AI) participants (time frame: Up to 5 years). The study lists 2 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 29 Jul 2026.