Liquid Biopsy-informed Precision Oncology Study to Evaluate Utility of Plasma Genomic Profiling for Therapy Selection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Oncology Patients All participants in the study. |
Other: 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.
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Outcome Measures
Primary Outcome Measures
- Prevalence of variants in ctDNA with clinical significance across different levels of evidence [Up to 2 years after enrollment]
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.
- Percentage of patients with a molecular tumor board (MTB) treatment recommendation [Up to 2 years after enrollment]
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.
- Percentage of patients treated according to MTB recommendation [Up to 2 years after enrollment]
To determine percentage of patients treated according to MTB recommendation.
- Turnaround time from collection of liquid biopsy to MTB recommendation [Up to 2 years after enrollment]
To determine turnaround time from collection of liquid biopsy to MTB recommendation.
- Time from MTB recommendation to treatment initiation [Up to 2 years after enrollment]
To determine the time from MTB recommendation to treatment initiation.
Secondary Outcome Measures
- Time to cancer therapy for patients who are treated according to MTB recommendation [Up to 2 years after enrollment]
To determine time to subsequent cancer therapy for patients who are treated according to MTB recommendation.
- Time to cancer therapy for patients who are not treated according to MTB recommendation [Up to 2 years after enrollment]
To determine time to subsequent cancer therapy for patients who are not treated according to MTB recommendation.
- Progression free-survival of patients who are treated according to the MTB recommendations [Up to 2 years after enrollment]
To determine the progression free-survival of patients who are treated according to the MTB recommendations.
- Progression free-survival of patients who are not treated according to the MTB recommendations [Up to 2 years after enrollment]
To determine the progression free-survival of patients who are not treated according to the MTB recommendations.
- Overall survival of patients who do receive treatment according to the MTB recommendations [Up to 2 years after enrollment]
To determine the overall survival of patients who do receive treatment according to the MTB recommendations.
- Overall survival of patients who do not receive treatment according to the MTB recommendations [Up to 2 years after enrollment]
To determine the overall survival of patients who do not receive treatment according to the MTB recommendations.
- MTB-based treatment recommendations stratified by therapeutic class [Up to 2 years after enrollment]
To determine MTB-based treatment recommendations stratified by therapeutic class (SOC, clinical trials, off-label use).
- Proportion of deviations from treatment recommendations [Up to 2 years after enrollment]
To determine the proportion of deviations from treatment recommendations.
- Reasons for deviations from treatment recommendations [Up to 2 years after enrollment]
To determine the reasons (clinical deterioration, other protocol, patient ineligible, off-label treatment unavailable, clinical trial not feasible (e.g. physical distance), clinical trial not recruiting, physician's decision, patient's choice, etc.) for deviations from treatment recommendations.
- Concordance of detected alterations obtained through liquid biopsy analyses [Up to 2 years after enrollment]
To determine the concordance of detected alterations obtained through liquid biopsy analyses at baseline compared to next generation sequencing of time-matched or archival tissue specimens.
- cfDNA yield obtained [Up to 2 years after enrollment]
To determine the cfDNA yield obtained through liquid biopsy analyses by tumor type.
- ctDNA amount obtained [Up to 2 years after enrollment]
To determine the ctDNA amount obtained through liquid biopsy analyses by tumor type.
- Liquid biopsy assay success rate [Up to 2 years after enrollment]
To determine the liquid biopsy assay success rate by tumor type and by pre-specified pre-analytical variables.
Other Outcome Measures
- Correlation of changes in ctDNA levels with radiologic response [Up to 2 years after enrollment]
To determine the correlation of changes in ctDNA levels with radiologic response by RECIST.
- Correlation of changes in ctDNA levels to progression-free survival [Up to 2 years after enrollment]
To determine the correlation of changes in ctDNA levels to progression-free survival.
- Correlation of changes in ctDNA levels to overall survival [Up to 2 years after enrollment]
To determine the correlation of changes in ctDNA levels to overall survival.
Eligibility Criteria
Criteria
Inclusion Criteria:
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ECOG performance status of 0-1.
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Patients with solid tumors, including esophageal cancer, non-adenocarcinoma NSCLC, small-cell lung cancer, head & neck cancer, mesothelioma, breast cancer and lung neuroendocrine cancer.
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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.
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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.
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Patients must have disease evaluable for progression assessment; measurable disease is not required to participate in the study.
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Able to voluntarily provide informed consent.
Exclusion Criteria:
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Women who are known to be pregnant
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Personal Genome Diagnostics
Investigators
- Principal Investigator: Valsamo Anagnostou, MD, PhD, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- J2271
- IRB00333925