Liquid Biopsy for Lung Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: City of Hope Medical Center
Disqualifiers: Lung cancer symptoms, Recent cancer, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This clinical trial investigates how practical and doable (feasibility) cell-free deoxyribonucleic acid (DNA) liquid biopsy is in screening high-risk patients for lung cancer. Currently, a low dose computed tomography (CT) scan is used to screen for lung cancer, however, due to various factors, few high-risk patients are screened. Liquid biopsy utilizes technology that can detect small amounts of DNA shed by cancer cells and may be able to spot lung cancer at an earlier stage. If a positive result comes back from the liquid biopsy, a patient may be more willing to get a low dose CT (LDCT) scan, possibly confirming the biopsy's findings and thus leading to more early lung cancer detection.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Cell-Free DNA Liquid Biopsy for lung cancer?
Research shows that cell-free DNA (cfDNA) testing is a promising tool for managing non-small-cell lung cancer (NSCLC). It offers a minimally invasive way to detect mutations, monitor treatment response, and assess tumor changes over time, which can help guide therapy decisions and avoid more invasive procedures.
12345Is liquid biopsy safe for humans?
Liquid biopsy, which includes cell-free DNA (cfDNA) testing, is considered safe because it is minimally invasive, involving only a blood test rather than a traditional tissue biopsy.
23467How is the Cell-Free DNA Liquid Biopsy treatment different from other lung cancer treatments?
The Cell-Free DNA Liquid Biopsy is unique because it is a minimally invasive blood test that analyzes cell-free DNA (cfDNA) to provide real-time information about the tumor's genetic makeup, allowing for early diagnosis, monitoring of treatment response, and detection of mutations without needing a traditional tissue biopsy.
23489Eligibility Criteria
This trial is for English-speaking individuals aged 50-80 who are at high risk for lung cancer due to a smoking history of 20 or more pack-years and, if they've quit, it was within the last 15 years. They must consent to screening with liquid biopsy or CT scan and have insurance covering LDCT at specified centers. Excluded are those with any recent cancer diagnosis (except non-melanoma skin cancer) or symptoms of lung cancer.Inclusion Criteria
Documented written informed consent of the participant.
Received referral for counseling for lung cancer screening and would qualify for LDCT.
Health Insurance that will pay for a LDCT for lung cancer screening at either City of Hope Duarte, Newport Beach (Newport Diagnostic Imaging), or Lancaster (Renaissance Imaging/Antelope Valley Outpatient Imaging Center).
+5 more
Exclusion Criteria
Any cancer diagnosis within past 5 years, excluding non-melanoma skin cancer.
Chest CT scan or chest positron emission tomography (PET)/CT within 12 months.
You have signs of lung cancer.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo either a liquid biopsy or low dose CT scan, with optional crossover based on results
4 weeks
1 visit (in-person or at home)
Follow-up
Participants are monitored for follow-through on screening and sociodemographic data collection
6 months
1 visit (in-person or virtual)
Participant Groups
The study is testing the practicality of using cell-free DNA liquid biopsies for early detection of lung cancer in high-risk patients compared to low dose CT scans. It aims to see if positive results from liquid biopsies encourage patients to follow up with CT scans, potentially increasing early detection rates.
2Treatment groups
Experimental Treatment
Group I: Cohort B (LDCT, optional liquid biopsy)Experimental Treatment3 Interventions
Participants undergo low dose CT with optional liquid biopsy on the same day as LDCT.
Group II: Cohort A (liquid biopsy, optional LDCT)Experimental Treatment3 Interventions
Participants undergo collection of blood sample (liquid biopsy), with option to undergo LDCT if liquid biopsy results are positive.
Cell-Free DNA Liquid Biopsy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Liquid Biopsy for:
- Non-small cell lung cancer screening in high-risk patients
🇪🇺 Approved in European Union as Liquid Biopsy for:
- Non-small cell lung cancer screening in high-risk patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
City of Hope Medical CenterDuarte, CA
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Who Is Running the Clinical Trial?
City of Hope Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Treatment of Non-Small-Cell Lung Cancer Based on Circulating Cell-Free DNA and Impact of Variation Allele Frequency. [2022]Next-generation sequencing of circulating cell-free DNA (cfDNA) can identify sensitizing and resistance mutations in non-small-cell lung cancer (NSCLC). cfDNA is helpful when tissue is insufficient for genomic testing or repeat biopsy is not feasible or poses unacceptable risk. Here we report the experience of cfDNA testing at the time of diagnosis and how this intervention can help avoid further invasive interventions, how it can be used to determine initiation of therapy, and how variation allele frequency of the somatic alteration affects response to subsequent treatment.
The role of circulating free DNA in the management of NSCLC. [2019]Circulating cell-free DNA (cfDNA) testing has emerged as an alternative to tumor tissue analyses for the management of metastatic non-small-cell lung cancer (NSCLC) patients. Analysis of cfDNA is a minimally invasive procedure that might better reflect tumor heterogeneity and allows repeated testing over the time. Areas covered: This review article covers the different applications of cfDNA testing in NSCLC: early diagnosis of the disease; detection of minimal residual disease in early lung cancer; identification of predictive and prognostic markers in advanced NSCLC patients; monitoring the response to therapy; assessment of tumor mutation burden. Expert commentary: The use of liquid biopsy is rapidly expanding to different applications. The combination of different circulating biomarkers (cfDNA, protein, miRNA) might improve the sensitivity and specificity of this approach in patients with low tumor burden. cfDNA testing is representing a valid source for molecular profiling in management of metastatic NSCLC patients and is providing important knowledge on tumor heterogeneity. Clinical trials are needed in order to transfer the information deriving from liquid biopsy testing in new therapeutic strategies.
Possible application of circulating free tumor DNA in non-small cell lung cancer patients. [2020]Liquid biopsies have been heralded as a game changer in cancer management. Blood tests offer a minimally invasive, safe and sensitive complementary (or even alternative) approach for tissue biopsies. With lung cancer being the second most commonly diagnosed cancer and the leading cause of cancer deaths worldwide, due to the limitations of tissue sampling, liquid biopsies must urgently materialize in the clinic. In this short review, we will present the current applications of cell-free DNA (cfDNA) in lung cancer management, emphasizing on our own experience and previous work. We will also shortly comment on the challenges and need for a coordinated collaboration combining disciplines and sectors (from academia to health economies) in order to accelerate liquid biopsy development in lung cancer and other cancers.
Noninvasive diagnosis of actionable mutations by deep sequencing of circulating free DNA in lung cancer from never-smokers: a proof-of-concept study from BioCAST/IFCT-1002. [2018]Tumor somatic mutation analysis is part of the standard management of metastatic lung cancer. However, physicians often have to deal with small biopsies and consequently with challenging mutation testing. Circulating free DNA (cfDNA) is a promising tool for accessing the tumor genome as a liquid biopsy. Here, we evaluated next-generation sequencing (NGS) on cfDNA samples obtained from a consecutive series of patients for the screening of a range of clinically relevant mutations.
Liquid biopsies in pediatric oncology: opportunities and obstacles. [2023]Liquid biopsies have emerged as a noninvasive alternative to tissue biopsy with potential applications during all stages of pediatric oncology care. The purpose of this review is to provide a survey of pediatric cell-free DNA (cfDNA) studies, illustrate their potential applications in pediatric oncology, and to discuss technological challenges and approaches to overcome these hurdles.
Monitoring of somatic mutations in circulating cell-free DNA by digital PCR and next-generation sequencing during afatinib treatment in patients with lung adenocarcinoma positive for EGFR activating mutations. [2022]Analysis of circulating cell-free DNA (cfDNA) is under intensive investigation for its potential to identify tumor somatic mutations. We have now explored the usefulness of such liquid biopsy testing with both the digital polymerase chain reaction (dPCR) and next-generation sequencing (NGS) during treatment of patients with the epidermal growth factor receptor (EGFR) inhibitor afatinib.
An Investigation into Cell-Free DNA in Different Common Cancers. [2023]Diagnosis is the most important step in different diseases, especially in cancers and blood malignancies. There are different methods in order to better diagnose of cancer, but many of them are invasive and also, some of them are not useful for immediate diagnosis. Cell-free DNA (cfDNA) or liquid biopsy easily accessible in peripheral blood is one of the non-invasive prognostic biomarkers in various areas of cancer management. In fact, amounts of cfDNA in serum or plasma can be used for diagnosis. In this review, we have considered some cancers such as hepatocellular carcinoma, lung cancer, breast cancer, and hematologic malignancies to compare the various methods of cfDNA diagnosis.
Liquid biopsy tracking of lung tumor evolutions over time. [2020]Introduction: The rise of the personalized era in lung cancer prompted the evaluation of novel diagnostic tools to overcome some of the limits of traditional tumor genotyping. Liquid biopsy refers to a multitude of minimally invasive techniques that can allow a real-time biomolecular characterization of the tumor through the analysis of human body fluids.Areas covered: Herein we provide a comprehensive overview of the role of liquid biopsy in lung cancer, mainly focusing on the most studied members of the liquid biopsy family, cell-free DNA (cfDNA) and circulating tumor cells (CTCs).Expert opinion: Among the different components of the large liquid biopsy family, cfDNA is the most studied and widely adopted source for tumor genotyping in lung cancer, already entered clinical practice for detection of both sensitizing and resistance EGFR mutations. However, the impressive technological advances made in the last few years are expanding its potential applications, allowing a more comprehensive plasma genotyping through next-generation sequencing and moving from advanced/metastatic disease to novel frontiers, such as early detection and minimal residual disease evaluation.
Early Blood-based Liquid Biopsy in Patients with Treatment-naïve Metastatic Adenocarcinoma of the Lung: A Case Series. [2022]Guidelines recommend testing for multiple biomarkers in non-small cell lung cancer (NSCLC) tumors. Blood-based liquid biopsy analyzing cell-free DNA (cfDNA) could be used in addition to tumor biopsy genotyping, especially if tissue/time are limiting.