Actively Recruiting

Age: 18Years +
All Genders
NCT05585684

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

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-11-20

150

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

Sponsors

S

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

P

Personal Genome Diagnostics

Collaborating Sponsor

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ECOG performance status of 0-1
  • Diagnosis of solid tumors including esophageal cancer, non-adenocarcinoma NSCLC, small-cell lung cancer, head and neck cancer, mesothelioma, breast cancer, or lung neuroendocrine cancer
  • Ability to provide whole blood samples totaling 20-30ml at baseline, 1-3 weeks after treatment starts, at first imaging, and at progression
  • Archival or time-matched tumor tissue sample preferred but not required, with at least 20% tumor content and 100 ng
  • For metastatic disease, progression on most recent treatment prior to enrollment or imminent progression expected by oncologist
  • Patients eligible for first-line standard treatments if efficacy is uncertain
  • Disease evaluable for progression; measurable disease not required
  • Able to give informed consent voluntarily
Not Eligible

You will not qualify if you...

  • Known pregnancy
  • History of another primary cancer within the last 5 years unless approved by the Protocol Chair
  • Prior in situ cancer or basal or localized squamous cell skin cancer are allowed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

V

Valsamo Anagnostou, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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