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Genetic Testing on Blood Samples for Treatment Suggestions in Patients with Advanced or Metastatic Cancer
Trial Status: active
This clinical trial studies whether genetic information obtained from blood is similar to genetic information obtained from tumor and if the information can be used to make treatment suggestions for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Genetic testing measures the circulating tumor deoxyribonucleic acid (ctDNA) in a sample, which is specific to the tumor cells or cancer. Most cancers release ctDNA into the circulation. This deoxyribonucleic acid (DNA) is separate from that found in blood and tissue samples which serve as the "instruction book" or “genetic code” for the cells that make up a person's body. The ctDNA helps to identify the genes that are important to the tumor cells, which can be used to identify standard of care (SOC) or research-based recommendations for therapy. Typically, genetic testing is performed on tumor samples, but tumor samples can be difficult to collect, which can prevent patients from undergoing this important testing. Obtaining genetic information from a blood sample may be similar to the information obtained from a tumor sample and may be an effective way to make treatment suggestions for patients with advanced or metastatic cancer.
Inclusion Criteria
Male or female
18 years of age or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Patients with solid tumors, including esophageal cancer, non-adenocarcinoma non-small cell lung cancer (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
Women who are known to be pregnant are excluded
No 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
Able to voluntarily provide informed consent
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05585684.
I. To determine the number and prevalence of variants in ctDNA with clinical significance across different levels of evidence (stratified by gene and alteration type).
II. 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.
III. To determine percentage of patients treated according to MTB recommendation.
IV. To determine turnaround time from collection of liquid biopsy to MTB recommendation.
V. To determine the timing from MTB recommendation to treatment initiation.
SECONDARY OBJECTIVES:
I. To determine time to subsequent cancer therapy for patients who are and are not treated according to MTB recommendation.
II. To determine the progression free-survival of patients who are and are not treated according to the MTB recommendations.
III. To determine the overall survival of patients who do and do not receive treatment according to the MTB recommendations.
IV. To determine MTB-based treatment recommendations stratified by therapeutic class (SOC, clinical trials, off-label use).
V. To determine the proportion of deviations from treatment recommendations and 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.).
VI. 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.
VII. To determine the cell-free deoxyribonucleic acid (cfDNA) yield and ctDNA amount obtained through liquid biopsy analyses by tumor type.
VIII. To determine the liquid biopsy assay success rate by tumor type and by pre-specified pre-analytical variables.
EXPLORATORY OBJECTIVES:
I. To determine the correlation of changes in ctDNA levels with radiologic response by Response Evaluation Criteria in Solid Tumors (RECIST).
II. To determine the correlation of changes in ctDNA levels to progression-free survival and overall survival.
OUTLINE:
Patients undergo collection of a blood sample and next generation sequencing (NGS) at baseline. After NGS results are available, patients undergo molecular tumor board (MTB) review and may receive tailored treatment recommendations based on identified actionable alterations. Patients also undergo collection of additional blood samples and tumor imaging throughout the study as well as collection of archival tissues samples on study.
After completion of study intervention, patients are followed up every 3 months until withdrawal from study or for 5 years from enrollment.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
