Metastatic NeoplasmNCT02566421
Genomic Sequencing in Determining Treatment in Patients With Metastatic Cancer or Cancer That Cannot Be Removed by Surgery
A study testing Laboratory Biomarker Analysis, Quality-of-Life Assessment and Targeted Therapy in people with Metastatic Neoplasm and Recurrent Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Neoplasm, Recurrent Neoplasm, Recurrent Non-Small Cell Lung Carcinoma
- What is being tested?
- Laboratory Biomarker Analysis, Quality-of-Life Assessment and Targeted Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Tumor cell sample available and of sufficient quantity in the Tumor Tissue Shared Resource or patients who are willing to undergo additional tissue collection for tumor genomic sequencing through FoundationOne; available specimens must have been harvested within two years to be eligible
- Alternative method:
Show all 11Show fewer
- Patients who are unwilling or unable to provide a tumor tissue sample and who undergoes Guardant360 sequencing may be considered eligible by the treating physician
- 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
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diminished mental capacity or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Precision Medicine for Patients With Malignancy at the Comprehensive Cancer Center of Wake Forest University
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of implementing a Precision Oncology protocol in the treatment of patients who undergo genomic sequencing.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Metastatic Neoplasm, Recurrent Neoplasm, Recurrent Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
- Being tested
- Laboratory Biomarker Analysis, Quality-of-Life Assessment, Targeted Therapy
- Medical subject headings
- Neoplasm Metastasis, Recurrence, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Targeted TherapyOther
Receive treatment based on genomic sequencing
| Study group | Role | What they receive |
|---|---|---|
| Treatment (precision medicine) | Experimental | Patients receive treatment based on the results of their genomic sequencing analyses. Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Targeted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline
Feasibility in terms of the ability to monitoring patient adverse events across separate treatment protocols and study teams.
Measured: Up to 2 years
Secondary outcomes (7)
Change in patient-reported symptoms of cancer and cancer treatment, as assessed by the MD Anderson Symptom Inventory
Measured: Baseline to up to 48 weeks
Patient's perceived quality care, as assessed by 3 items adapted from Arora, et al
Measured: Up to up to 48 weeks
Patient's satisfaction with treatment decision-making and decisional regret, as assessed by an adapted Satisfaction with Decision scale
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: Assessing Feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Angela Alistar, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566421
- Sponsor's protocol ID
- IRB00033598
- Other IDs
- NCI-2015-01373, CCCWFU 01615, IRB00033598, CCCWFU # 01615, P30CA012197
- Status last verified
- Jun 2018
- First submitted
- 14 Sep 2015
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine for Patients With Malignancy at the Comprehensive Cancer Center of Wake Forest University
- ClinicalTrials.gov ID
- NCT02566421
- Acronym / sponsor ID
- IRB00033598
- Conditions
- Metastatic Neoplasm, Recurrent Neoplasm, Recurrent Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Assessing Feasibility
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of implementing a Precision Oncology protocol in the treatment of patients who undergo genomic sequencing.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (precision medicine) | Experimental | Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: Targeted TherapyPatients receive treatment based on the results of their genomic sequencing analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Absence of clinically relevant liver or kidney failure as deemed by the treating physician
Key exclusion criteria (2 listed)
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diminished mental capacity or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (precision medicine) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (precision medicine) |
| Targeted TherapyReceive treatment based on genomic sequencing | Other | Treatment (precision medicine) |
Primary outcome
Feasibility in terms of the ability to monitoring patient outcomes across separate treatment protocols and study teams.
Time frame: Up to 2 years
Typical patient outcome measures will necessarily vary by disease, so survival will be the overarching outcome measure.
Proportion of patients enrolled on this protocol who are subsequently enrolled in a clinical trial based on the results of the genomic sequencing
Time frame: 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
Time frame: Baseline
The observed proportion and corresponding 95% confidence intervals will be estimated.
Proportion of patients with an actionable mutation
Time frame: Baseline
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.
Feasibility in terms of the ability to monitoring patient adverse events across separate treatment protocols and study teams.
Time frame: Up to 2 years
7 secondary outcomes
Change in patient-reported symptoms of cancer and cancer treatment, as assessed by the MD Anderson Symptom Inventory
Time frame: Baseline to up to 48 weeks
Patient's perceived quality care, as assessed by 3 items adapted from Arora, et al
Time frame: Up to up to 48 weeks
Patient's satisfaction with treatment decision-making and decisional regret, as assessed by an adapted Satisfaction with Decision scale
Time frame: 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
Time frame: Up to up to 48 weeks
Survival rate in patients who receive targeted treatment versus those who do not receive targeted treatment
Time frame: Up to 6 months
Survival rate in patients who receive targeted treatment versus those who do not receive targeted treatment
Time frame: Up to 12 months
Treatment response rates in patients who receive targeted treatment versus those who do not receive targeted treatment
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Assessing Feasibility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Alistar principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Biomarker Analysis, Quality-of-Life Assessment and Targeted Therapy in people with Metastatic Neoplasm and Recurrent Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Assessing Feasibility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility in terms of the ability to monitoring patient outcomes across separate treatment protocols and study teams. (time frame: Up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.