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

NCT05585684 | Recruiting

• 2 other identifiers: J2271IRB00333925
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Prevalence of variants in ctDNA with clinical significance across different levels of evidence

  To determine the prevalence of variants in ctDNA with clinical significance across different levels of evidence (stratified by gene and alteration type). In cases where tumor next-generation sequencing has been performed, tumor mutational profiles will be evaluated in conjunction with the liquid biopsy results.

  Up to 2 years after enrollment

• Percentage of patients with a molecular tumor board (MTB) treatment recommendation

  To determine the percentage of patients with a molecular tumor board (MTB) treatment recommendation tailored to an actionable alteration according to the mutation profiles detected by liquid biopsies.

  Up to 2 years after enrollment

• Percentage of patients treated according to MTB recommendation

  To determine percentage of patients treated according to MTB recommendation.

  Up to 2 years after enrollment

• Turnaround time from collection of liquid biopsy to MTB recommendation

  To determine turnaround time from collection of liquid biopsy to MTB recommendation.

  Up to 2 years after enrollment

• Time from MTB recommendation to treatment initiation

  To determine the time from MTB recommendation to treatment initiation.

  Up to 2 years after enrollment

Secondary Outcomes (13)

• Time to cancer therapy for patients who are treated according to MTB recommendation

  Up to 2 years after enrollment

• Time to cancer therapy for patients who are not treated according to MTB recommendation

  Up to 2 years after enrollment

• Progression free-survival of patients who are treated according to the MTB recommendations

  Up to 2 years after enrollment

• Progression free-survival of patients who are not treated according to the MTB recommendations

  Up to 2 years after enrollment

• Overall survival of patients who do receive treatment according to the MTB recommendations

  Up to 2 years after enrollment

Other Outcomes (3)

• Correlation of changes in ctDNA levels with radiologic response

  Up to 2 years after enrollment

• Correlation of changes in ctDNA levels to progression-free survival

  Up to 2 years after enrollment

• Correlation of changes in ctDNA levels to overall survival

  Up to 2 years after enrollment

Study Arms (1)

Oncology Patients

All participants in the study.

Other: Non-invasive Comprehensive Genomic Profiling for Cancer Treatment Selection

Interventions

Non-invasive Comprehensive Genomic Profiling for Cancer Treatment Selection OTHER

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

Oncology Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with solid tumors, including esophageal cancer, non-adenocarcinoma NSCLC, small-cell lung cancer, head \& neck cancer, mesothelioma, breast cancer and lung neuroendocrine cancer.

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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Personal Genome Diagnostics: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, tissue

Study Officials

• Valsamo Anagnostou, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valsamo Anagnostou, MD, PhD

CONTACT

410-955-8964; ThoracicCancerTrials@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 19, 2022
• Study Start: January 27, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)