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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05585684.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins Bayview Medical CenterStatus: Active
Contact: Valsamo Anagnostou
Phone: 410-614-8948
Johns Hopkins University/Sidney Kimmel Cancer CenterStatus: Active
Contact: Valsamo Anagnostou
Phone: 410-614-8948
Lutherville
Johns Hopkins at Green Spring StationStatus: Active
Contact: Valsamo Anagnostou
Phone: 410-614-8948
PRIMARY OBJECTIVES:
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
Principal InvestigatorValsamo Anagnostou
