NCT05585684 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Liquid Biopsy-informed Precision Oncology Study to Evaluate Utility of Plasma Genomic Profiling for Therapy Selection
What this study is about
Overall, this project has three main goals: first, to ascertain the feasibility of the approach and identify whether liquid biopsies can detect actionable mutations that can be utilized to generate precision oncology treatment recommendations.
View original scientific description
Overall, this project has three main goals: first, to ascertain the feasibility of the approach and identify whether liquid biopsies can detect actionable mutations that can be utilized to generate precision oncology treatment recommendations. Second, the investigators will investigate whether enacting upon MTB recommendations would improve outcomes in terms of progression-free and overall survival. Third, the investigators aim to determine if molecular profiling via serial plasma tests after initiation of chemotherapy or other targeted treatment is sufficient to determine whether or not a patient is responding to therapy.
Interventions
OTHER
Non-invasive Comprehensive Genomic Profiling for Cancer Treatment Selection
Use of liquid biopsy to evaluate the clinical utility of non-invasive comprehensive genomic profiling for cancer treatment selection.
Primary outcome measures
Prevalence of variants in ctDNA with clinical significance across different levels of evidence
Time frame: Up to 2 years after enrollment
To determine the prevalence of variants in ctDNA with clinical significance across different levels of evidence (stratified by gene and alteration type). In cases where tumor next-generation sequencing has been performed, tumor mutational profiles will be evaluated in conjunction with the liquid biopsy results.
Percentage of patients with a molecular tumor board (MTB) treatment recommendation
Time frame: Up to 2 years after enrollment
To determine the percentage of patients with a molecular tumor board (MTB) treatment recommendation tailored to an actionable alteration according to the mutation profiles detected by liquid biopsies.
Percentage of patients treated according to MTB recommendation
Time frame: Up to 2 years after enrollment
To determine percentage of patients treated according to MTB recommendation.
Turnaround time from collection of liquid biopsy to MTB recommendation
Time frame: Up to 2 years after enrollment
To determine turnaround time from collection of liquid biopsy to MTB recommendation.
Time from MTB recommendation to treatment initiation
Time frame: Up to 2 years after enrollment
To determine the time from MTB recommendation to treatment initiation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ECOG performance status of 0-1.
- Patients with solid tumors, including esophageal cancer, non-adenocarcinoma NSCLC, small-cell lung cancer, head \& neck cancer, mesothelioma, breast cancer and lung neuroendocrine cancer.
- Patients who can provide whole blood collection to meet minimum of 20-30ml of blood at baseline, within 1-3 weeks from treatment initiation, at first radiographic imaging and at progression. Acquisition of an archival or time-matched tumor tissue specimen which meets the minimum sample input requirements (at least 20% tumor content and 100 ng) is preferred but not required.
- Patients with metastatic disease will have progressed on the most recent treatment prior to enrollment. Patient can also be enrolled if their oncologist believes progression is imminent and test results would be used to inform next line of therapy. Patients considered for first-line SOC therapeutic options may be enrolled if the clinical efficacy of these therapies is not encouraging.
- Patients must have disease evaluable for progression assessment; measurable disease is not required to participate in the study.
- Able to voluntarily provide informed consent.
Exclusion criteria
- Women who are known to be pregnant
- History of another primary malignancy in the last 5 years prior to registration unless approved by the Protocol Chair/designee. Patients with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.
Where
- Baltimore, Maryland
Collaborators
Personal Genome Diagnostics
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 20, 2025 · Source of record for eligibility and locations