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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01373 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 01615 | |||
| IRB00033598 | |||
| CCCWFU # 01615 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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Assessing Feasibility
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (precision medicine) | Experimental | Patients receive treatment based on the results of their genomic sequencing analyses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility in terms of the ability to monitoring patient outcomes across separate treatment protocols and study teams. | Typical patient outcome measures will necessarily vary by disease, so survival will be the overarching outcome measure. | Up to 2 years |
| Proportion of patients enrolled on this protocol who are subsequently enrolled in a clinical trial based on the results of the genomic sequencing | Baseline | |
| Proportion of patients enrolled on this protocol who have a clinical trial identified for them to be enrolled in based on the results of the genomic sequencing | The observed proportion and corresponding 95% confidence intervals will be estimated. | Baseline |
| Proportion of patients with an actionable mutation | Each patient enrolled will be dichotomized into either having a clinical trial identified (yes/no) that the results of their genomic sequencing suggests. The observed proportion and corresponding 95% confidence intervals will be estimated. | Baseline |
| Feasibility in terms of the ability to monitoring patient adverse events across separate treatment protocols and study teams. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient-reported symptoms of cancer and cancer treatment, as assessed by the MD Anderson Symptom Inventory | Baseline to up to 48 weeks | |
| Patient's perceived quality care, as assessed by 3 items adapted from Arora, et al | Up to up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic variant data | Exploratory statistical genetic and bioinformatics analyses will be made 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 | Up to 2 years |
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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| Name | Affiliation | Role |
|---|---|---|
| Angela Alistar | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| Quality-of-Life Assessment |
| Other |
Ancillary studies |
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| Targeted Therapy | Other | Receive treatment based on genomic sequencing |
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| Patient's satisfaction with treatment decision-making and decisional regret, as assessed by an adapted Satisfaction with Decision scale | Up to up to 48 weeks |
| Self-perceived burden, as assessed by the Self-Perceived Burden Scale-Short form for measuring chronic disease patients' feelings of being a burden on their caregivers | Up to up to 48 weeks |
| Survival rate in patients who receive targeted treatment versus those who do not receive targeted treatment | Kaplan Meier curves will be estimated and groups will be compared using Log-Rank tests. These analyses will be performed across all disease sites and then stratified by disease site. | Up to 6 months |
| Survival rate in patients who receive targeted treatment versus those who do not receive targeted treatment | Kaplan Meier curves will be estimated and groups will be compared using Log-Rank tests. These analyses will be performed across all disease sites and then stratified by disease site. | Up to 12 months |
| Treatment response rates in patients who receive targeted treatment versus those who do not receive targeted treatment | For each patient a clinical response assessment will be ascertained and compared between groups. 95% confidence intervals will be estimated for the response rates (with stable disease [SD], partial response [PR] and complete response [CR] pooled together) and the repeated with PR and CR pooled together. | Up to 2 years |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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