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Observational Study of Liquid Biopsy for Solid Tumors

This study is looking at how a "liquid biopsy" (a blood test) can help doctors choose the best treatments for people with solid tumors, including certain lung, breast, and head & neck cancers. The liquid biopsy, called Non-invasive Comprehensive Genomic Profiling, checks your blood for tiny pieces of cancer DNA to find specific changes (variants) that might respond to certain therapies. Doctors will then discuss these findings in a "molecular tumor board" (MTB) to recommend treatments. The study aims to see how often these variants are found, how often doctors make treatment recommendations based on them, and how often patients receive those recommended treatments. You would need to be at least 18 years old and have a good performance status (ECOG 0-1) to participate. This is an observational study, meaning researchers will watch and collect information without giving new treatments.

Study design
This is an observational study with a planned enrollment of 150 participants. It is not specified if it is randomized or blinded.
What's involved
You would need to provide 20-30ml of blood at the start of the study, within 1-3 weeks of starting treatment, and at other times not fully specified. The study will track information for up to 2 years after you enroll.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years after enrollment to assess the prevalence of variants, MTB recommendations, and treatment adherence.

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NCT05585684

Liquid Biopsy-informed Precision Oncology Study to Evaluate Utility of Plasma Genomic Profiling for Therapy Selection

Recruiting
Not specifiedAges 18+Observational
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~150 participants
Updated 2025-11-20 on ClinicalTrials.gov
What's tested:Non-invasive Comprehensive Genomic Profiling for Cancer Treatment Selection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of variants in ctDNA with clinical significance across different levels of evidence
Measured over Up to 2 years after enrollment
+4 more outcomes measured

Conditions

Solid Tumor

Explore related trials

Breast CarcinomaEsophageal CarcinomaLung Neuroendocrine CancerLung Non-Small Cell CarcinomaLung Small Cell CarcinomaMalignant Head and Neck NeoplasmMesothelial NeoplasmSolid Neoplasm

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Valsamo Anagnostou, MD, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Valsamo Anagnostou, MD, PhD
[email protected]
410-955-8964
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Prevalence of variants in ctDNA with clinical significance across different levels of evidenceUp 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 recommendationUp 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 recommendationUp to 2 years after enrollment

    To determine percentage of patients treated according to MTB recommendation.

  • Turnaround time from collection of liquid biopsy to MTB recommendationUp to 2 years after enrollment

    To determine turnaround time from collection of liquid biopsy to MTB recommendation.

  • Time from MTB recommendation to treatment initiationUp to 2 years after enrollment

    To determine the time from MTB recommendation to treatment initiation.