RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-27

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05585684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Valsamo Anagnostou, MD, PhD

CONTACT

410-614-8948

vanagno@jhmi.edu

Peggy Fitzpatrick, RN

CONTACT

410-550-5848

mfitzpa7@jhmi.edu

Principal Investigator

Valsamo Anagnostou, MD, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Valsamo Anagnostou, MD, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-27

Study Completion Date2025-09

Study Record Updates

Study Start Date2023-01-27

Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

Solid Tumor