Using blood tests to guide cancer treatment decisions

Liquid Biopsy-informed Precision Oncology Study to Evaluate the Clinical Utility of Non-invasive Comprehensive Genomic Profiling for Cancer Treatment Selection

This study tests if blood tests can help doctors find the best cancer treatments for patients with solid tumors and see how well those treatments are working.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05585684 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the feasibility of using liquid biopsies to detect actionable mutations in patients with solid tumors. It will assess whether following molecular profiling recommendations can improve patient outcomes, specifically progression-free and overall survival. Additionally, the study will investigate the effectiveness of serial plasma tests in monitoring patient responses to chemotherapy or targeted treatments. Data will be collected through secure case report forms and monitored for quality assurance.

Who should consider this trial

Good fit: Ideal candidates include patients with solid tumors who have an ECOG performance status of 0-1 and can provide the necessary blood samples.

Not a fit: Patients with non-solid tumors or those who are unable to provide the required blood samples may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective cancer treatment strategies for patients.

How similar studies have performed: Other studies have shown promise in using liquid biopsies for precision oncology, indicating that this approach is gaining traction in the field.

Eligibility criteria

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 this trial is running

Baltimore, Maryland

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

Study contacts

• Principal investigator: Valsamo Anagnostou, MD, PhD — Johns Hopkins University
• Study coordinator: Valsamo Anagnostou, MD, PhD

Conditions Solid Tumor