Lung CarcinomaNCT06482073
Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care
An observational study of Lung Carcinoma and Metastatic Malignant Neoplasm in the Lung, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates the effectiveness of tumor samples in providing information about hereditary or cancer specific genetic variants that may have a role in diagnosis of cancer and to develop genetic results and medical record databank for future studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoma, Metastatic Malignant Neoplasm in the Lung
- What is being tested?
- Non-Interventional Study
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 1 Jul 2027
- 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: Patients scheduled for a bronchoscopy recruited through Mayo Clinic
Who may be able to join
- Subject age 18 years and older
- Subject is scheduled/was scheduled for a bronchoscopy or surgical resection as part of standard of care
- Subject with a moderate to high risk of lung cancer based on clinical demographic and radiologic information or with suspected metastatic disease
- Ability to provide blood or saliva sample
- Ability to provide archived tissue
- Subject is able to understand and adhere to study requirements and able to provide informed consent
Who cannot join
- Individuals who have situations that would limit compliance with the study requirements
- Institutionalized (i.e. federal medical prison)
- Pregnant
- Prior germline genetic testing with a 40+ multi-gene panel AND/OR prior somatic tissue (250+ gene) testing utilizing the tissue from the bronchoscopy or surgical resection
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 Rochester
Rochester, Minnesota, 55905
Thoracic Research, 507-293-0807, RSTTHORACICRES@mayo.edu
Janani S. Reisenauer, M.D.
About this study
Official title: Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (INTERCEPTioN for Suspected Lung Cancer)for Suspected Lung Cancer)
This study evaluates the effectiveness of tumor samples in providing information about hereditary or cancer specific genetic variants that may have a role in diagnosis of cancer and to develop genetic results and medical record databank for future studies.
Read the detailed description
PRIMARY OBJECTIVES:
- Assessing whether the percentage of samples adequate for WES (Whole Exome Sequencing)/WT (Wild-Type) sequencing is at least 80%.
II. Development of a data bank of WES/WT and germline sequencing data for future analyses.
OUTLINE: This is an observational study.
Patients receive genomic counseling and genomic testing education, undergo blood or saliva collection, provide previously collected tissue sample and have medical records reviewed on study. Patients and healthcare providers receive results of any genetic variants found on testing.
- Being tested
- Non-Interventional Study
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients receive genomic counseling and genomic testing education, undergo blood or saliva collection, provide previously collected tissue sample and have medical records reviewed on study. Patients and healthcare providers receive results of any genetic variants found on testing. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of samples adequate for sequencing
Assessed based on the number of tissue samples determined to be adequate for WES (Whole Exome Sequencing)/WT (wild-type) sequencing.
Measured: Up to 2 years
Secondary outcomes (1)
Data bank of genomic data
A data bank of genomic data will be developed for future analyses.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start24 Jun 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janani S. Reisenauer, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482073
- Sponsor's protocol ID
- 24-000609
- Other IDs
- NCI-2024-04855, 24-000609
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (INTERCEPTioN for Suspected Lung Cancer)for Suspected Lung Cancer)
- ClinicalTrials.gov ID
- NCT06482073
- Acronym / sponsor ID
- 24-000609
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 1 Jul 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 study evaluates the effectiveness of tumor samples in providing information about hereditary or cancer specific genetic variants that may have a role in diagnosis of cancer and to develop genetic results and medical record databank for future studies.
Detailed description
PRIMARY OBJECTIVES:
- Assessing whether the percentage of samples adequate for WES (Whole Exome Sequencing)/WT (Wild-Type) sequencing is at least 80%.
II. Development of a data bank of WES/WT and germline sequencing data for future analyses.
OUTLINE: This is an observational study.
Patients receive genomic counseling and genomic testing education, undergo blood or saliva collection, provide previously collected tissue sample and have medical records reviewed on study. Patients and healthcare providers receive results of any genetic variants found on testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients receive genomic counseling and genomic testing education, undergo blood or saliva collection, provide previously collected tissue sample and have medical records reviewed on study. Patients and healthcare providers receive results of any genetic variants found on testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for a bronchoscopy recruited through Mayo Clinic
Key inclusion criteria (6 listed)
- Subject age 18 years and older
- Subject is scheduled/was scheduled for a bronchoscopy or surgical resection as part of standard of care
- Subject with a moderate to high risk of lung cancer based on clinical demographic and radiologic information or with suspected metastatic disease
- Ability to provide blood or saliva sample
- Ability to provide archived tissue
Key exclusion criteria (4 listed)
- Individuals who have situations that would limit compliance with the study requirements
- Institutionalized (i.e. federal medical prison)
- Pregnant
- Prior germline genetic testing with a 40+ multi-gene panel AND/OR prior somatic tissue (250+ gene) testing utilizing the tissue from the bronchoscopy or surgical resection
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Percent of samples adequate for sequencing
Time frame: Up to 2 years
Assessed based on the number of tissue samples determined to be adequate for WES (Whole Exome Sequencing)/WT (wild-type) sequencing.
1 secondary outcome
Data bank of genomic data
Time frame: Up to 2 years
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 8 Sep 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.
Janani S. Reisenauer, M.D. principal investigator
Mayo Clinic in Rochester
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 Lung Carcinoma and Metastatic Malignant Neoplasm in the Lung, 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 6 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: looking for participants now, as of the sponsor's last update on 8 Sep 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 Thoracic Research (507-293-0807, RSTTHORACICRES@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of samples adequate for sequencing (time frame: Up to 2 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 8 Sep 2026.