Recruiting

Precision Oncology

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT05585684

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-invasive Comprehensive Genomic Profiling for Cancer Treatment Selection

Study Details

Brief summary:

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

Solid Tumor

Study ID

NCT05585684

Start date

Jan 27, 2023

Status verified date

Nov, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Oncology Patients

All participants in the study.

Interventions

Non-invasive Comprehensive Genomic Profiling for Cancer Treatment Selection

Use of liquid biopsy to evaluate the clinical utility of non-invasive comprehensive genomic profiling for cancer treatment selection.

Primary outcome measure

  • Prevalence of variants in ctDNA with clinical significance across different levels of evidence [ Time Frame: Up to 2 years after enrollment ]
  • Percentage of patients with a molecular tumor board (MTB) treatment recommendation [ Time Frame: Up to 2 years after enrollment ]
  • Percentage of patients treated according to MTB recommendation [ Time Frame: Up to 2 years after enrollment ]
  • Turnaround time from collection of liquid biopsy to MTB recommendation [ Time Frame: Up to 2 years after enrollment ]
  • Time from MTB recommendation to treatment initiation [ Time Frame: Up to 2 years after enrollment ]

Central Contacts and Locations

Central contacts

Valsamo Anagnostou, MD, PhD

410-955-8964ThoracicCancerTrials@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Valsamo Anagnostou, MD, PhD

410-955-8964ThoracicCancerTrials@jhmi.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2025-11-20.