NCT05585684RecruitingNot Applicable

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country150 target enrollmentStarted: January 27, 2023Last updated: November 20, 2025

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Enrollment: 150
Locations: 1
Primary Endpoint: Prevalence of variants in ctDNA with clinical significance across different levels of evidence

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Detailed Description

Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.

All information will be collected on study-specific case report forms (CRFs) hosted in Redcap and/or directly entered into a study database. The following measures will be taken to protect patient information:

The database will be password protected; only authorized staff may enter and view project data.
Passwords and system IDs will not be shared.
Physical security of the workstations/files will be maintained. Workstations with the database open will not be left unattended.
Staff will be trained on the data entry system and on security procedures.
The study data will be reviewed/monitored by the Sidney Kimmel Comprehensive Cancer Center Clinical Research Office and the Cancer Center Safety committee.

Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Data checks will be performed per SKCCC SOP DM-01-04 CRF Documentation Standards.

Case Report Form (CRF): A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. ICH GCP 1.11 Source Documents: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at the medicotechnical departments involved in the clinical trial). ICH GCP 1.52 3. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (for example, medical records, paper or electronic case report forms, or interactive voice response systems).

All study data will be reviewed for completeness and accuracy by the Protocol Chair who will ensure the completeness and accuracy of the data generated. The designated research coordinator(s) participating in this project will collect clinical information associated with each participant. Such data could include, but is not limited to: medical record number, age, sex, treatment history, circulating tumor markers, tumor size, tumor grade, tumor receptor status, pathology report, smoking history, hormonal history, concomitant medications, and parity. Such information will be retrieved from existing clinical databases/EMR (e.g., EPIC) and patient questionnaire information, and may also include electronic scheduling and prescription systems.

Study Design

Study Type: Observational
Observational Model: Other
Time Perspective: Prospective

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•ECOG performance status of 0-
•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.