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

Recruiting now

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT05585684

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

150

Starts

2023-01-27

Expected to finish

2027-09-01

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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