Using blood tests to guide cancer treatment decisions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ThoracicCancerTrials@jhmi.edu
• Phone: 410-955-8964

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.