Lung; NodeNCT05665504
Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
An observational study of Lung; Node and Adenocarcinoma of Lung, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This study is an observational study of blood and tissue biomarkers. Investigators plan to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung; Node, Adenocarcinoma of Lung
- What is being tested?
- DetermaRX
- Type of treatment
- Pill or oral medicine
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to Feb 2028
- 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 seen in the Moffitt Thoracic Surgery and Lung Diagnosis Clinics.
Who may be able to join
- Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer [clinical stage IA-IB (cT1a-T2aN0), <4cm diameter].
- If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center.
- If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center.
- >18 years old, male or female.
- ECOG performance status 0-1.
- Agree to participate in the follow-up protocol.
- Any suspected primary lung cancer cell type (except a suspected typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma).
- Ability to understand and the willingness to sign a written, informed consent document.
Who cannot join
- Participants who are actively receiving any cancer treatment.
- Participants with uncontrolled intercurrent illness.
- Prior lung cancer within 5 years.
- Current active other major cancer except non-melanoma skin cancer.
- Patients with pure ground glass opacities (nodules) or hilar masses.
- Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma).
Show all 10Show fewer
- Metastatic nodule (suspected) in the lung from an extrapulmonary cancer.
- Patient unable to provide informed consent.
- Prisoner or incarcerated individual.
- For surgical patients, a R1 or R2 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
Moffitt Cancer Center
Tampa, Florida, 33612
Brianna Aponte, 813-745-0787, Brianna.Aponte@moffitt.org
Lary A Robinson, MD
About this study
This study is an observational study of blood and tissue biomarkers. Investigators plan to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Investigators also plan to examine another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer. Finally, investigators plan to determine if one of the blood-based biomarkers can be used to detect any late cancer recurrence.
- Conditions
- Lung; Node, Adenocarcinoma of Lung
- Being tested
- DetermaRX
- Keywords
- Biomarkers, Lung Cancer Biomarkers
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DetermaRXDiagnostic test
A lung tissue biomarker to risk stratify patients immediately after curative lung cancer resections into groups with low risk versus intermediate-high risk for recurrence of cancer. Intermediate-high risk patients will be advised to undergo adjuvant chemotherapy with the expectation of decreasing their chance of recurrence. The effectiveness and toxicity of the adjuvant chemotherapy itself is considered not part of the study-just the decision to recommend adjuvant chemotherapy is the study intervention. Investigators will then evaluate the long-term survival results of low-risk patients (no adjuvant treatment) and intermediate-high risk patients receiving adjuvant treatment versus intermediate-high risk patients who decline adjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| High-Risk for Recurrence That Accept Adjuvant Chemotherapy | Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participants also have a special mutation on the tumor (EGFR), investigators will recommend that the participant also receive the oral anti-EGFR pill (TagrissoTM) daily for 3 years after completing the chemotherapy. The administration of standard postoperative chemotherapy is not considered part of the study. Only the results of the DetermaRx test is a part of this study. Receives: Diagnostic Test: DetermaRX | |
| High-Risk for Recurrence That Decline Adjuvant Chemotherapy | Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participant declines, investigators will followup with participants periodically every 6-12 months over 5 years. Receives: Diagnostic Test: DetermaRX | |
| Low-Risk for Recurrence | Participants whose gene assay show that they are at a lower risk of recurrence will not be offered additional treatment after resection. Investigators will followup with participants periodically every 6-12 months over 5 years. Receives: Diagnostic Test: DetermaRX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
Disease-free survival (DFS) is defined as the time from surgical resection and adjuvant chemotherapy to recurrence of tumor or death
Measured: Up to 5 years
Overall Survival
Overall survival (OS) is defined as the time (days) from the date of surgical resection and adjuvant chemotherapy to the date of death, due to any reason.
Measured: Up to 5 Years
Secondary outcomes (2)
Tumor Malignancy
Fisher exact test will used to test association of both LCDT1™, NodifyXL2®, and CIZ1b™ blood tests with malignancy.
Measured: At 6 Months
Cancer Recurrence
Fisher exact test will used to test association of LCDT-1™ blood test with cancer recurrence.
Measured: At 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start11 Jan 2023
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung; NodeStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lary A Robinson, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665504
- Sponsor's protocol ID
- MCC-21767
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
- ClinicalTrials.gov ID
- NCT05665504
- Acronym / sponsor ID
- MCC-21767
- Conditions
- Lung; Node, Adenocarcinoma of Lung
- Keywords
- Biomarkers, Lung Cancer Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 27 Dec 2022 (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 an observational study of blood and tissue biomarkers. Investigators plan to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Investigators also plan to examine another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer. Finally, investigators plan to determine if one of the blood-based biomarkers can be used to detect any late cancer recurrence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Risk for Recurrence That Accept Adjuvant Chemotherapy | – | Diagnostic Test: DetermaRXParticipants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participants also have a special mutation on the tumor (EGFR), investigators will recommend that the participant also receive the oral anti-EGFR pill (TagrissoTM) daily for 3 years after completing the chemotherapy. The administration of standard postoperative chemotherapy is not considered part of the study. Only the results of the DetermaRx test is a part of this study. |
| High-Risk for Recurrence That Decline Adjuvant Chemotherapy | – | Diagnostic Test: DetermaRXParticipants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participant declines, investigators will followup with participants periodically every 6-12 months over 5 years. |
| Low-Risk for Recurrence | – | Diagnostic Test: DetermaRXParticipants whose gene assay show that they are at a lower risk of recurrence will not be offered additional treatment after resection. Investigators will followup with participants periodically every 6-12 months over 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in the Moffitt Thoracic Surgery and Lung Diagnosis Clinics.
Key inclusion criteria (8 listed)
- Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer [clinical stage IA-IB (cT1a-T2aN0), <4cm diameter].
- If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center.
- If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center.
- >18 years old, male or female.
- ECOG performance status 0-1.
Key exclusion criteria (10 listed)
- Participants who are actively receiving any cancer treatment.
- Participants with uncontrolled intercurrent illness.
- Prior lung cancer within 5 years.
- Current active other major cancer except non-melanoma skin cancer.
- Patients with pure ground glass opacities (nodules) or hilar masses.
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 |
|---|---|---|
| DetermaRXA lung tissue biomarker to risk stratify patients immediately after curative lung cancer resections into groups with low risk versus intermediate-high risk for recurrence of cancer. Intermediate-high risk patients will be advised to undergo adjuvant chemotherapy with the expectation of decreasing their chance of recurrence. The effectiveness and toxicity of the adjuvant chemotherapy itself is considered not part of the study-just the decision to recommend adjuvant chemotherapy is the study intervention. Investigators will then evaluate the long-term survival results of low-risk patients (no adjuvant treatment) and intermediate-high risk patients receiving adjuvant treatment versus intermediate-high risk patients who decline adjuvant therapy. | Diagnostic test | High-Risk for Recurrence That Accept Adjuvant Chemotherapy, High-Risk for Recurrence That Decline Adjuvant Chemotherapy, Low-Risk for Recurrence |
Primary outcome
Disease Free Survival
Time frame: Up to 5 years
Disease-free survival (DFS) is defined as the time from surgical resection and adjuvant chemotherapy to recurrence of tumor or death
Overall Survival
Time frame: Up to 5 Years
Overall survival (OS) is defined as the time (days) from the date of surgical resection and adjuvant chemotherapy to the date of death, due to any reason.
2 secondary outcomes
Tumor Malignancy
Time frame: At 6 Months
Cancer Recurrence
Time frame: At 6 Months
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 1 Apr 2026.
- Moffitt Cancer Center Clinical Trial SearchLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lung; Node
Active, not recruiting
Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules
Lung Cancer, Lung; Node
RecruitingPhase 2
A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment
Lung Non-Small Cell Carcinoma
Recruiting
Robotic Systems Evaluation for Peripheral Pulmonary Lesions (RISE Trial)
Lung; Node
RecruitingPhase 2
Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node or Other High Risk Features
Non-small Cell Lung Cancer Stage III
RecruitingObservational study
Augmented Endobronchial Ultrasound (EBUS-TBNA) With Artificial Intelligence
Artificial Intelligence, Endobronchial Ultrasound
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.
Lary A Robinson, MD principal investigator
Moffitt Cancer Center
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; Node and Adenocarcinoma of Lung, run by H. Lee Moffitt Cancer Center and Research Institute 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 8 inclusion and 10 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 1 Apr 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 Brianna Aponte (813-745-0787, Brianna.Aponte@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (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 1 Apr 2026.