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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 below

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I have a lung nodule between 8-40 mm suspected to be early-stage cancer.

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My lung cancer is not a typical carcinoid, carcinoma in situ, or minimally-invasive.

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I am fully active or can carry out light work.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,245 Total Patients Enrolled

Lary A Robinson, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

DetermaRX (Biomarker Test) Clinical Trial Eligibility Overview. Trial Name: NCT05665504 — N/A

Lung Adenocarcinoma Research Study Groups: High-Risk for Recurrence That Decline Adjuvant Chemotherapy, Low-Risk for Recurrence, High-Risk for Recurrence That Accept Adjuvant Chemotherapy

Lung Adenocarcinoma Clinical Trial 2023: DetermaRX Highlights & Side Effects. Trial Name: NCT05665504 — N/A

DetermaRX (Biomarker Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05665504 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participants in this experiment?

"Indeed, the clinicaltrials.gov website indicates that recruitment for this medical trial is open. The study was posted on December 19th 2022 and its most recent update occurred on the same date. 250 individuals are sought from a single clinical site."

Answered by AI

Is this research endeavor currently seeking volunteers?

"Affirmative. According to the information found on clinicaltrials.gov, this experiment is currently recruiting participants and was initially posted on December 19th 2022 with its latest update also being made that day. It needs 250 people to be recruited from one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer

2023. "Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05665504.

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