Your session is about to expire
← Back to Search
Biomarker Test
Biomarker Testing with DetermaRX for Lung Cancer Monitoring
N/A
Recruiting
Led By Lary A Robinson, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Potentially-resectable lung nodule 8-40 mm diameter suspected of being a clinically node-negative lung cancer (clinical stage IA-IB)
Any suspected primary lung cancer cell type (except typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial evaluates the accuracy of blood biomarkers to detect lung cancer & to identify high-risk patients after surgery & detect late recurrence.
Who is the study for?
This trial is for adults who may have early-stage lung cancer, with a lung nodule sized 8-40 mm and no spread to lymph nodes. They must be fit enough for surgery or radiotherapy at Moffitt Cancer Center, able to follow up, and consent to the study. Excluded are those with certain types of nodules, other active major cancers, prior lung cancer within 5 years, ongoing cancer treatment, inability to consent or incarceration.Check my eligibility
What is being tested?
The study observes blood and tissue biomarkers in patients. It aims to assess if blood biomarkers can accurately diagnose lung nodules as benign or malignant; identify high recurrence risk post-surgery using tissue biomarkers; and monitor late recurrence through blood markers.See study design
What are the potential side effects?
Since this is an observational study focusing on diagnostic biomarkers rather than treatments like drugs or surgeries (beyond standard care), it does not introduce additional side effects related directly to the interventions being studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a lung nodule between 8-40 mm suspected to be early-stage cancer.
Select...
My lung cancer is not a typical carcinoid, carcinoma in situ, or minimally-invasive.
Select...
I am fully active or can carry out light work.
Select...
I am recommended to have SBRT at Moffitt Cancer Center instead of surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Free Survival
Overall Survival
Secondary outcome measures
Cancer Recurrence
Tumor Malignancy
Trial Design
3Treatment groups
Experimental Treatment
Group I: Low-Risk for RecurrenceExperimental Treatment1 Intervention
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.
Group II: High-Risk for Recurrence That Decline Adjuvant ChemotherapyExperimental Treatment1 Intervention
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.
Group III: High-Risk for Recurrence That Accept Adjuvant ChemotherapyExperimental Treatment1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Lung Adenocarcinoma include targeted therapies and immunotherapies. Targeted therapies, such as EGFR tyrosine kinase inhibitors, block the activity of specific proteins that are mutated and overactive in cancer cells, thereby inhibiting tumor growth.
Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the immune system's ability to recognize and destroy cancer cells by preventing the interaction between PD-1 on immune cells and PD-L1 on cancer cells. These treatments are particularly important for patients with specific genetic mutations or high PD-L1 expression, as they can offer more effective and personalized treatment options with potentially fewer side effects compared to traditional chemotherapy.
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
548 Previous Clinical Trials
135,378 Total Patients Enrolled
Lary A Robinson, MDPrincipal InvestigatorMoffitt Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lung nodule between 8-40 mm suspected to be early-stage cancer.I am currently undergoing cancer treatment.My surgery left some cancer cells behind.I am unable to understand and give consent for treatment.My tumor is suspected to be a typical carcinoid.My lung cancer is not a typical carcinoid, carcinoma in situ, or minimally-invasive.My scans show nodules or masses near my lung's air passages.I am over 18 years old.I am fully active or can carry out light work.I do not have any active cancer except for non-melanoma skin cancer.I had lung cancer within the last 5 years.I am willing to have surgery at Moffitt Cancer Center if advised.I do not have any uncontrolled illnesses.I am recommended to have SBRT at Moffitt Cancer Center instead of surgery.My cancer has spread to my lung from another part of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Low-Risk for Recurrence
- Group 2: High-Risk for Recurrence That Decline Adjuvant Chemotherapy
- Group 3: High-Risk for Recurrence That Accept Adjuvant Chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger