Non-small Cell Lung CancerNCT02273336
Comprehensive Genomic Analysis in Tissue and Blood Samples From Young Patients With Lung Cancer
An observational study of Non-small Cell Lung Cancer and Small Cell Lung Cancer, run by University of Southern California at 2 sites in United States.
Trial summary
This research trial studies genomic analysis in tissue and blood samples from young patients with lung cancer. Identifying specific gene mutations (changes in deoxyribonucleic acid [DNA]) may help doctors tailor treatment to target the specific mutations and help plan effective treatment. Read more about this study
- Who is it for?
- Ages Up to 39 years
- Conditions the study is for
- Non-small Cell Lung Cancer, Small Cell Lung Cancer
- What is being tested?
- cytology specimen collection procedure and laboratory biomarker analysis
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jul 2014to 8 Sep 2020
- Phase
- Observational
- 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 Up to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects will be recruited at Dana Farber Institute and USC Norris Cancer Center.
Who may be able to join
- COHORT 1: LUNG CANCER PATIENTS
- Pathologically confirmed bronchogenic lung carcinoma (small cell lung cancer [SCLC] or non-small cell lung cancer [NSCLC] of any stage) at any treatment time point
- For individuals diagnosed with advanced disease (stage IV or recurrent) enrollment must occur within 2 years of diagnosis
- For appropriate patients (stage IV non-squamous NSCLC) epidermal growth factor receptor (EGFR ) and anaplastic lymphoma kinase (ALK) genotyping performed by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory is recommended prior to participation
- Provision of written informed consent
- Willingness to undergo a single blood draw
Show all 10Show fewer
- Individuals who are under 18 are eligible for study if they meet the defined criteria for cohort 1; in addition, consent for participation must be given by a legal guardian or parent
- NOTE: to be eligible for genomics, availability of 10 unstained slides (plus hematoxylin and eosin [H\&E] slide) or an adequate formalin-fixed paraffin-embedded (FFPE) tumor block from clinically indicated interventional procedures is required
- COHORT 2: DECEASED INDIVIDUALS
- Deceased individuals diagnosed with lung cancer at any age less than 40 may be studied on a case by case basis depending upon Institutional Review Board (IRB) approval at a participating institution; inclusion will require availability of adequate archived FFPE tissue and release of tissue and records by next of kin, if available
Who cannot join
- Compromise of patient diagnosis or staging if tissue is used for research
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Genomics of Young Lung Cancer Study
This research trial studies genomic analysis in tissue and blood samples from young patients with lung cancer. Identifying specific gene mutations (changes in deoxyribonucleic acid [DNA]) may help doctors tailor treatment to target the specific mutations and help plan effective treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To perform comprehensive genomic analysis of young lung cancer patients' samples to facilitate delivery of targeted therapies and clinical trial enrollment.
II. To characterize the impact of young age at lung cancer diagnosis on the genomic landscape of primary lung cancer.
III. To establish a prospective registry of young lung cancer patients for both tumor and germline next generation sequencing.
OUTLINE:
Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.
After completion of study, patients are followed up every 3 months for up to 3 years.
- Conditions
- Non-small Cell Lung Cancer, Small Cell Lung Cancer
- Being tested
- cytology specimen collection procedure, laboratory biomarker analysis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytology specimen collection procedureOther
Also called cytologic sampling
Undergo tissue and blood sample collection
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (comprehensive genomic analysis) | Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing. Receives: Other: cytology specimen collection procedure; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of targetable mutations, defined as any alteration in a drive oncogene for which Food and Drug Administration-approved therapy exists, for which an off-label therapy exists, or for which a clinical trial exists
Will compare this population with the historical experience of the Lung Cancer Mutation Consortium. For this specific comparison, the prevalence of mutations in EGFR, ALK, v-raf murine sarcoma viral oncogene homolog B1 (BRAF), human epidermal growth factor receptor 2 (HER2), v-ros avian UR2 sarcoma virus oncogene homolog 1 (ROS1), and met proto-oncogene (MET) will be calculated.
Measured: Baseline
Proportion of young lung cancer patients that enroll onto clinical trials
Measured: Baseline
Proportion of patients that received targeted therapies based on their clinical genotyping results
Measured: Baseline
Acquired deactivating mutations
All data summaries based on next generation sequencing of tumor and blood deoxyribonucleic acid/ribonucleic acid will be descriptive, with the goal of discovering novel tumor suppressor genes that may be deactivated leading to the development of NSCLC in individuals less than 40 years.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study start22 Jul 2014
- Primary completion8 Aug 2020
- Study completion8 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Medicine, Addario Lung Cancer Medical Institute, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Barbara Gitlitz, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273336
- Sponsor's protocol ID
- ALCMI-003
- Other IDs
- NCI-2014-02098, 2L-14-1, ALCMI-003, P30CA014089
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2014
- Last updated
- 18 Nov 2021
- 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 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics of Young Lung Cancer Study
- ClinicalTrials.gov ID
- NCT02273336
- Acronym / sponsor ID
- ALCMI-003
- Conditions
- Non-small Cell Lung Cancer, Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Foundation Medicine, Addario Lung Cancer Medical Institute, National Cancer Institute (NCI)
- Study start
- 22 Jul 2014 (actual)
- Primary completion
- 8 Aug 2020 (actual)
- Study completion
- 8 Sep 2020 (actual)
- First posted
- 23 Oct 2014 (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 research trial studies genomic analysis in tissue and blood samples from young patients with lung cancer. Identifying specific gene mutations (changes in deoxyribonucleic acid [DNA]) may help doctors tailor treatment to target the specific mutations and help plan effective treatment.
Detailed description
PRIMARY OBJECTIVES:
- To perform comprehensive genomic analysis of young lung cancer patients' samples to facilitate delivery of targeted therapies and clinical trial enrollment.
II. To characterize the impact of young age at lung cancer diagnosis on the genomic landscape of primary lung cancer.
III. To establish a prospective registry of young lung cancer patients for both tumor and germline next generation sequencing.
OUTLINE:
Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.
After completion of study, patients are followed up every 3 months for up to 3 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (comprehensive genomic analysis) | – | Other: cytology specimen collection procedure, Other: laboratory biomarker analysisTissue and blood samples are analyzed via next generation sequencing and whole exome sequencing. |
Who may qualify
- Ages
- Up to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects will be recruited at Dana Farber Institute and USC Norris Cancer Center.
Key inclusion criteria (10 listed)
- COHORT 1: LUNG CANCER PATIENTS
- Pathologically confirmed bronchogenic lung carcinoma (small cell lung cancer [SCLC] or non-small cell lung cancer [NSCLC] of any stage) at any treatment time point
- For individuals diagnosed with advanced disease (stage IV or recurrent) enrollment must occur within 2 years of diagnosis
- For appropriate patients (stage IV non-squamous NSCLC) epidermal growth factor receptor (EGFR ) and anaplastic lymphoma kinase (ALK) genotyping performed by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory is recommended prior to participation
- Provision of written informed consent
Key exclusion criteria (1 listed)
- Compromise of patient diagnosis or staging if tissue is used for research
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 |
|---|---|---|
| cytology specimen collection procedureAlso: cytologic samplingUndergo tissue and blood sample collection | Other | Ancillary-Correlative (comprehensive genomic analysis) |
| laboratory biomarker analysisCorrelative studies | Other | Ancillary-Correlative (comprehensive genomic analysis) |
Primary outcome
Prevalence of targetable mutations, defined as any alteration in a drive oncogene for which Food and Drug Administration-approved therapy exists, for which an off-label therapy exists, or for which a clinical trial exists
Time frame: Baseline
Will compare this population with the historical experience of the Lung Cancer Mutation Consortium. For this specific comparison, the prevalence of mutations in EGFR, ALK, v-raf murine sarcoma viral oncogene homolog B1 (BRAF), human epidermal growth factor receptor 2 (HER2), v-ros avian UR2 sarcoma virus oncogene homolog 1 (ROS1), and met proto-oncogene (MET) will be calculated.
Proportion of young lung cancer patients that enroll onto clinical trials
Time frame: Baseline
Proportion of patients that received targeted therapies based on their clinical genotyping results
Time frame: Baseline
Acquired deactivating mutations
Time frame: Baseline
All data summaries based on next generation sequencing of tumor and blood deoxyribonucleic acid/ribonucleic acid will be descriptive, with the goal of discovering novel tumor suppressor genes that may be deactivated leading to the development of NSCLC in individuals less than 40 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
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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.
Barbara Gitlitz, MD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Small Cell Lung Cancer, run by University of Southern California at 2 sites 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 10 inclusion and 1 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: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of targetable mutations, defined as any alteration in a drive oncogene for which Food and Drug Administration-approved therapy exists, for which an off-label therapy exists, or for which a clinical trial exists (time frame: Baseline). The study lists 4 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 18 Nov 2021.