Lung NeoplasmsNCT01946100
Treatment of Multifocal Lung Adenocarcinoma
A study testing Multifocal Lung Adenocarcinoma in people with Lung Neoplasms and Carcinoma Non-small-cell Lung, run by Mayo Clinic at 1 site in United States.
Trial summary
To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Carcinoma Non-small-cell Lung, Adenocarcinoma
- What is being tested?
- Multifocal Lung Adenocarcinoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2013to 29 May 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Patient must be > 18 years of age
- Two or more GGO's or solid lesions suspicious for multifocal disease.
- Clinical diagnosis of N0
- No evidence of distant metastases
- No prior intra-thoracic radiation therapy (NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted.), previous chemotherapy, or surgical resection for non-small cell lung cancer (NSCLC).
- No other cancer in the past 5 years except early stage prostate cancer, or basal cell of skin.
- PFT's that show patient is capable of tolerating a lung resection.
- Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study.
- Patient must be able to understand and willing to sign an IRB-approved informed consent document.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Clinical Pathway for the Treatment of Multifocal Lung Adenocarcinoma Using Genome Sequencing
To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC.
Read the detailed description
Lung bronchoalveolar carcinoma (BAC) or adenocarcinoma in situ (AIS) continues to represent a poorly understood clinical entity. A frequent clinical dilemma in lung cancer care is the management of a documented or suspected invasive adenocarcinoma in the setting of multifocal ground glass opacity (GGO) consistent with multifocal AIS. These patients are typically classified as stage IV disease, and treated with palliative chemotherapy. No existing pathologic or molecular test is currently capable of making the distinction between independent primary versus metastatic tumors, a distinction for which substantial treatment impact exists. Many treating physicians suspect that outcomes for this specific patient subgroup are better than norms for stage IV disease, as such patients are frequently node-negative and without distant metastases despite multiple lesions present. To address this issue, we will evaluate a multimodality treatment protocol using aggressive local and targeted systemic therapy for multifocal lung adenocarcinoma, incorporating information from tumor genome sequencing for individualized treatment planning. The results will have significant impact in advancing the biologic understanding and treatment approach for lung adenocarcinoma in the setting of multifocal AIS.
- Being tested
- Multifocal Lung Adenocarcinoma
- Keywords
- multifocal, genetic, bronchoalveolar carcinoma, adenocarcinoma in situ, ground glass opacity, next generation sequencing
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Adenocarcinoma, Bronchiolo-Alveolar, Adenocarcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifocal Lung AdenocarcinomaGenetic
Tissue collection at the time of surgery for genetic testing and blood sample for germ line DNA.
| Study group | Role | What they receive |
|---|---|---|
| Multifocal Lung Adenocarcinoma | Other | Not described Receives: Genetic: Multifocal Lung Adenocarcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival compared to survival for Stage IV NSCLC on NCCTG trials
Measured: 2 years
Secondary outcomes (3)
Progressive free survival
Progressive free survival
Measured: Every 3 months for 2 years
Treatment Morbidity and Mortality
Treatment Morbidity and Mortality
Measured: 2 years
Post-treatment Pulmonary Function
Post-treatment Pulmonary Function measured by pulmonary function testing (spirometry)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study start6 Nov 2013
- Primary completion29 May 2025
- Study completion29 May 2025
Why it stopped: Funding ended prior to completion of enrollment.
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 Lung NeoplasmsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Wigle, Mayo Clinic
- Investigators
- Dennis Wigle, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946100
- Sponsor's protocol ID
- 12-007569
- Status last verified
- Nov 2025
- First submitted
- 16 Sep 2013
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saddoughi SA, Powell C, Stroh GR, Rajagopalan S, Bartholmai BJ, Boland JM, Aubry MC, Harmsen WS, Blackmon SH, Cassivi SD, Nichols FC, Reisenauer JS, Shen KR, Mansfield AS, Maldonado F, Peikert T, Wigle DA. Long-Term Survival and CANARY-Based Artificial Intelligence for Multifocal Lung Adenocarcinoma. Mayo Clin Proc Digit Health. 2024 Jan 11;2(1):44-52. doi: 10.1016/j.mcpdig.2023.10.006. eCollection 2024 Mar.
PubMed 40206677
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pathway for the Treatment of Multifocal Lung Adenocarcinoma Using Genome Sequencing
- ClinicalTrials.gov ID
- NCT01946100
- Acronym / sponsor ID
- 12-007569
- Keywords
- multifocal, genetic, bronchoalveolar carcinoma, adenocarcinoma in situ, ground glass opacity, next generation sequencing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended prior to completion of enrollment.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Nov 2013 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 19 Sep 2013 (estimated)
- 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.
To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC.
Detailed description
Lung bronchoalveolar carcinoma (BAC) or adenocarcinoma in situ (AIS) continues to represent a poorly understood clinical entity. A frequent clinical dilemma in lung cancer care is the management of a documented or suspected invasive adenocarcinoma in the setting of multifocal ground glass opacity (GGO) consistent with multifocal AIS. These patients are typically classified as stage IV disease, and treated with palliative chemotherapy. No existing pathologic or molecular test is currently capable of making the distinction between independent primary versus metastatic tumors, a distinction for which substantial treatment impact exists. Many treating physicians suspect that outcomes for this specific patient subgroup are better than norms for stage IV disease, as such patients are frequently node-negative and without distant metastases despite multiple lesions present. To address this issue, we will evaluate a multimodality treatment protocol using aggressive local and targeted systemic therapy for multifocal lung adenocarcinoma, incorporating information from tumor genome sequencing for individualized treatment planning. The results will have significant impact in advancing the biologic understanding and treatment approach for lung adenocarcinoma in the setting of multifocal AIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multifocal Lung Adenocarcinoma | Other | Genetic: Multifocal Lung Adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Multifocal Lung AdenocarcinomaTissue collection at the time of surgery for genetic testing and blood sample for germ line DNA. | Genetic | Multifocal Lung Adenocarcinoma |
Primary outcome
Overall Survival
Time frame: 2 years
Overall survival compared to survival for Stage IV NSCLC on NCCTG trials
3 secondary outcomes
Progressive free survival
Time frame: Every 3 months for 2 years
Treatment Morbidity and Mortality
Time frame: 2 years
Post-treatment Pulmonary Function
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Funding ended prior to completion of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 40206677Saddoughi SA, Powell C, Stroh GR, Rajagopalan S, Bartholmai BJ, Boland JM, Aubry MC, Harmsen WS, Blackmon SH, Cassivi SD, Nichols FC, Reisenauer JS, Shen KR, Mansfield AS, Maldonado F, Peikert T, Wigle DA. Long-Term Survival and CANARY-Based Artificial Intelligence for Multifocal Lung Adenocarcinoma. Mayo Clin Proc Digit Health. 2024 Jan 11;2(1):44-52. doi: 10.1016/j.mcpdig.2023.10.006. eCollection 2024 Mar.
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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.
Dennis Wigle, MD, PhD 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 Multifocal Lung Adenocarcinoma in people with Lung Neoplasms and Carcinoma Non-small-cell 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?
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: stopped early, as of the sponsor's last update on 20 Nov 2025. 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 was stopped early (reason given: Funding ended prior to completion of enrollment.). Results are not available in the source record.
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?
Overall Survival (time frame: 2 years). 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 NCT01946100, 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 20 Nov 2025.