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About
This pilot clinical trial studies patients' genomic sequencing in determining specific treatments, also called Precision Medicine, in patients with cancer that has spread to other parts of the body (metastatic) and/or cannot be removed by surgery. Examining the genetic code of a patient's tumor, a mutation (a change in the deoxyribonucleic acid [DNA] sequence of a cell or gene) may be identified and matched with available treatment that targets the mutated gene or an alternative treatment that may provide benefit for the patient with the mutation identified. Precision medicine may impacts patient's response to treatment by targeting specific mutations and may increase survival and improve quality of life.
Full description
PRIMARY OBJECTIVES:
I. To assess the feasibility of implementing a Precision Oncology protocol in the treatment of patients who undergo genomic sequencing.
SECONDARY OBJECTIVES:
I. To determine treatment response rates in patients who receive targeted treatment versus those who do not receive targeted treatment.
II. To assess survival in patients who receive targeted treatment versus those who do not receive targeted treatment.
III. To assess changes in patient-reported outcomes in patients who receive targeted treatment versus those who do not receive targeted treatment.
IV. To perform exploratory statistical genetic and bioinformatics analyses using the data derived from the genomic sequencing to catalogue additional important variants and determine whether there are any patterns or associations among patient level risk factors, their outcomes and genomic information that was not identified by the original genomic sequencing analyses.
OUTLINE:
Patients receive treatment based on the results of their genomic sequencing analyses.
After completion of study treatment, patients are followed up every 2 months.
Enrollment
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Inclusion criteria
Patients with unresectable cancer for which there are genomic drivers with corresponding Food and Drug Administration (FDA) approved or experimental drugs available, e.g. non-small cell lung cancer; and/or patients with histologically confirmed metastatic malignancy that have failed standard treatment or cannot tolerate standard treatment as deemed by the treating physician
Malignancy must be measureable as per appropriate guidelines
Patients who are willing to provide a specimen for genomic sequencing
Preferred method:
Alternative method:
Patients who have already had their specimens sent for genomic sequencing are eligible provided they have not received their sequencing results at the time of enrollment
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Absence of clinically relevant liver or kidney failure as deemed by the treating physician
Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Exclusion criteria
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110 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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