CancerINTERCEPTioNNCT06008392
INTERogating Cancer for Etiology, Prevention and Therapy Navigation
An observational study of Cancer and Cancer Gene Mutation, run by Mayo Clinic at 5 sites in United States.
Trial summary
This study is being done to identify markers and causes of cancer by analyzing patient's DNA (i.e., genetic material), RNA, plasma, tissues, or other samples that could be informative for patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer Gene Mutation, PAN Gene Mutation
- What is being tested?
- Pan-genomic Testing
- How many people
- 500 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Oct 2023to Sep 2033
- How long will I take part?
- 50 Years
- Phase
- Observational
- 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
Study population: Participants identified internally to Mayo Clinic will be enrolled. The Mayo Clinic study team and/or subspecialty teams will identify participants that fulfill enrollment criteria. Only individuals with a confirmed cancer diagnosis who know they have cancer will be asked to participate. Group B will enroll patients who do not meet NCCN and CMS guidelines for somatic tissue testing and/or whom have had somatic tissue testing, but not germline testing previously.
Who may be able to join
- GROUP A: Germline and Somatic Testing
- Has Mayo Clinic medical record number
- Confirmed cancer diagnosis
- Germline and/or somatic tumor/blood testing has been ordered by the clinical provider (or clinical delegate)
- Participant aware of cancer diagnosis
- Able to provide informed consent
Show all 43Show fewer
- ≥ 18 years old
- Ability to provide blood, saliva, bone marrow aspirate or hair follicle sample
- Ability to provide archived tissue, if somatic testing has not already been completed
- Note: if tissue unavailable participant may still enroll onto the study for the germline collection, or vice versa, if germline has already been completed may still enroll for somatic tissue/blood testing.
- GROUP B: Germline testing only:
- Has Mayo Clinic medical record number
- Confirmed cancer diagnosis
- Germline testing has been ordered by the clinical provider (or clinical delegate)
- Participant aware of cancer diagnosis
- Able to provide informed consent
- ≥ 18 years old
- Ability to provide blood, saliva, or hair follicle sample
- GROUP C: Somatic tumor testing only:
- Has Mayo Clinic medical record number,
- Confirmed cancer diagnosis,
- Somatic tumor/blood testing has been ordered by the clinical provider (or clinical delegate)
- Participant aware of cancer diagnosis,
- Able to provide informed consent,
- ≥ 18 years old
- Ability to provide archived tissue or blood for somatic tumor genomic profiling, if not already completed.
- Group D: Clinical standard of care germline testing via genetic counselor:
- Has Mayo Clinic medical record number,
- Standard of care clinical visit with genetic counselor
- Confirmed cancer diagnosis,
- Germline testing has been ordered by the clinical provider (or clinical delegate)
- Participant aware of cancer diagnosis,
- Able to provide informed consent,
- ≥ 18 years old
- Ability to provide blood, saliva, or hair follicle sample
- Group E: Previous Enrollment in IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810:
- Enrolled in any of the following studies: IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810
- Completed Riskguard, OncoExtra, Caris Assure, or Caris MI Profile or any combination of these tests.
- Has Mayo Clinic medical record number,
- Confirmed cancer diagnosis,
- Participant aware of cancer diagnosis
- Able to provide informed consent,
- ≥ 18 years old
Who cannot join
- Note: Women who are pregnant or planning to become pregnant can take part in this study.
- GROUP A: Germline and Somatic testing
- Individuals who have situations that would limit compliance with the study requirements
- Institutionalized (i.e. Federal Medical Prison)
- GROUP B: Germline testing only
- Individuals who have situations that would limit compliance with the study requirements
Show all 17Show fewer
- Institutionalized (i.e. Federal Medical Prison)
- Prior germline genetic testing with a 100+ multi-gene panel within the last 1 year of enrollment
- Group C: Somatic tumor testing only:
- Individuals who have situations that would limit compliance with the study requirements,
- Institutionalized (i.e. Federal Medical Prison),
- Group D: Clinical standard of care germline testing via genetic counselor:
- Individuals who have situations that would limit compliance with the study requirements,
- Institutionalized (i.e. Federal Medical Prison)
- Group E: Previous Enrollment in IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810:
- Individuals who have situations that would limit compliance with the study requirements,
- Institutionalized (i.e. Federal Medical Prison)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54703
Cancer Center CRC Team, 507-266-7492, Interception@mayo.edu
Samina Hirani, MBBS
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Cancer Center CRC Team, 507-266-7492, Interception@mayo.edu
Jeremy C. Jones, MD
- Recruiting
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
Cancer Center CRC Team, 507-266-7492, Interception@mayo.edu
Tezo Karedan, MD
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Cancer Center CRC Team, 507-266-7492, Interception@mayo.edu
Mrinal S. Patnaik, MBBS
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Cancer Center CRC Team, 507-266-7492, Interception@mayo.edu
Jewel J. Samadder, MD
About this study
Official title: INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)
This study is being done to identify markers and causes of cancer by analyzing patient's DNA (i.e., genetic material), RNA, plasma, tissues, or other samples that could be informative for patients with cancer. Cancer genetic testing is a series of tests that finds specific changes in cancer cells and normal cells in the body. Researchers may request to access these data as they explore how to better prevent, screen, or treat cancer. This study is also being done to create a biobank (library) of samples and information to learn more about treating cancer. Discovery of genetic variants in patients with cancer could result in opportunities for cancer prevention, earlier diagnosis or better therapy for cancer.
- Conditions
- Cancer, Cancer Gene Mutation, PAN Gene Mutation, Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- Being tested
- Pan-genomic Testing
- Keywords
- Whole Exome Sequencing (WES), Whole Genome Sequencing (WGS), Genetic Testing, Genetic Counseling, Genomics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pan-genomic TestingGenetic
Also called Genetic testing
Participants will be scheduled to review the study specifics, review consent and gather medical information. Once consented, samples will be collected. When the samples are received by Exact Sciences, DNA and RNA will be extracted, and sequencing will be performed. Following pan-genomic testing, participants will receive the full report with results from their care team and results will also be added to the patient's portal. If a germline finding is identified (positive pathogenic variant) the participant will also be referred for a genetic counselor visit. All results from the germline hereditary test will be reviewed by a certified genetic counselor in addition to a review of their pedigree. To help with review of any genetic research findings, the study team may request to obtain genomic data from previous genetic testing (clinical or research based).
| Study group | Role | What they receive |
|---|---|---|
| Group A: Germline and Somatic Testing | Potential participants with a cancer diagnosis may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made. Receives: Genetic: Pan-genomic Testing | |
| Group B: Germline Testing Only | Potential participants with a cancer diagnosis may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made. Receives: Genetic: Pan-genomic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic sequencing of tumor tissue and blood
Genomic sequencing of tumor tissue and blood will be performed to determine genomic alterations in germline and somatic cancer-related genes (SNVs, indels, CNVs from DNA and fusions from RNA) to allow the ordering hematologist/oncologist/provider to determine optimal therapy and clinical trial prospective. Researchers across the field of genomic sequencing report findings about new variations in scientific publications and collect it in databases every day. Consequently, any patient's variant of uncertain significance (VUS) result could be reclassified by emerging findings, turning previously unresolved tests into diagnostic answers. Our Translational Omics Program has a system to re-analyze a patient's exome/genome data against these new genetic findings-reviewing data and comparing it with emerging clinical genetic data to facilitate diagnoses.
Measured: Baseline; 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start12 Oct 2023
- Primary completionSep 2033 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jewel J. Samadder, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008392
- Sponsor's protocol ID
- 22-008878
- Other IDs
- NCI-2024-03113
- Acronym
- INTERCEPTioN
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2023
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)
- ClinicalTrials.gov ID
- NCT06008392
- Acronym / sponsor ID
- INTERCEPTioN / 22-008878
- Conditions
- Cancer, Cancer Gene Mutation, PAN Gene Mutation, Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- Keywords
- Whole Exome Sequencing (WES), Whole Genome Sequencing (WGS), Genetic Testing, Genetic Counseling, Genomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- Sep 2033 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 23 Aug 2023 (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 study is being done to identify markers and causes of cancer by analyzing patient's DNA (i.e., genetic material), RNA, plasma, tissues, or other samples that could be informative for patients with cancer. Cancer genetic testing is a series of tests that finds specific changes in cancer cells and normal cells in the body. Researchers may request to access these data as they explore how to better prevent, screen, or treat cancer. This study is also being done to create a biobank (library) of samples and information to learn more about treating cancer. Discovery of genetic variants in patients with cancer could result in opportunities for cancer prevention, earlier diagnosis or better therapy for cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Germline and Somatic Testing | – | Genetic: Pan-genomic TestingPotential participants with a cancer diagnosis may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made. |
| Group B: Germline Testing Only | – | Genetic: Pan-genomic TestingPotential participants with a cancer diagnosis may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants identified internally to Mayo Clinic will be enrolled. The Mayo Clinic study team and/or subspecialty teams will identify participants that fulfill enrollment criteria. Only individuals with a confirmed cancer diagnosis who know they have cancer will be asked to participate. Group B will enroll patients who do not meet NCCN and CMS guidelines for somatic tissue testing and/or whom have had somatic tissue testing, but not germline testing previously.
Key inclusion criteria (43 listed)
- GROUP A: Germline and Somatic Testing
- Has Mayo Clinic medical record number
- Confirmed cancer diagnosis
- Germline and/or somatic tumor/blood testing has been ordered by the clinical provider (or clinical delegate)
- Participant aware of cancer diagnosis
Key exclusion criteria (17 listed)
- Note: Women who are pregnant or planning to become pregnant can take part in this study.
- GROUP A: Germline and Somatic testing
- Individuals who have situations that would limit compliance with the study requirements
- Institutionalized (i.e. Federal Medical Prison)
- GROUP B: Germline testing only
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 |
|---|---|---|
| Pan-genomic TestingAlso: Genetic testingParticipants will be scheduled to review the study specifics, review consent and gather medical information. Once consented, samples will be collected. When the samples are received by Exact Sciences, DNA and RNA will be extracted, and sequencing will be performed. Following pan-genomic testing, participants will receive the full report with results from their care team and results will also be added to the patient's portal. If a germline finding is identified (positive pathogenic variant) the participant will also be referred for a genetic counselor visit. All results from the germline hereditary test will be reviewed by a certified genetic counselor in addition to a review of their pedigree. To help with review of any genetic research findings, the study team may request to obtain genomic data from previous genetic testing (clinical or research based). | Genetic | Group A: Germline and Somatic Testing, Group B: Germline Testing Only |
Primary outcome
Genomic sequencing of tumor tissue and blood
Time frame: Baseline; 50 years
Genomic sequencing of tumor tissue and blood will be performed to determine genomic alterations in germline and somatic cancer-related genes (SNVs, indels, CNVs from DNA and fusions from RNA) to allow the ordering hematologist/oncologist/provider to determine optimal therapy and clinical trial prospective. Researchers across the field of genomic sequencing report findings about new variations in scientific publications and collect it in databases every day. Consequently, any patient's variant of uncertain significance (VUS) result could be reclassified by emerging findings, turning previously unresolved tests into diagnostic answers. Our Translational Omics Program has a system to re-analyze a patient's exome/genome data against these new genetic findings-reviewing data and comparing it with emerging clinical genetic data to facilitate diagnoses.
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 16 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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 J. Samadder, MD principal investigator
Mayo Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cancer Gene Mutation, run by Mayo Clinic at 5 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 43 inclusion and 17 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 16 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 5 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 Cancer Center CRC Team (507-266-7492, Interception@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic sequencing of tumor tissue and blood (time frame: Baseline; 50 years). 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 16 Oct 2026.