Lung CancerNCT01517971
Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology at 1 site in United States.
Trial summary
This research trial studies biomarkers in predicting the risk of cancer returning after surgery in tissue samples of patients with early-stage non-small cell lung cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- laboratory biomarker analysis
- How many people
- 1,060 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 27 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with NSCLC enrolled on the Cancer and Leukemia Group B (CALGB) 140202
Who may be able to join
- Registration to CALGB-140202
- The subject population to be studied in this protocol includes patients selected from CALGB-140202; all such patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into that trial; the CALGB does not require that a separate consent form be signed for this study
- All samples to be studied were obtained and stored as part of CALGB-140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
- Tumor specimens need to have 40% tumor content to be included
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Validation of Molecular Prognostic Tests in NSCLC
This research trial studies biomarkers in predicting the risk of cancer returning after surgery in tissue samples of patients with early-stage non-small cell lung cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict how well patients will respond to treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To develop and validate a clinically useful molecular prognostic signature based on ribonucleic acid (RNA)-expression arrays to accurately distinguish between good and poor outcome in patients with stage 1B non-small cell lung cancer (NSCLC) (T2aN0M0) by predicting the risk of cancer recurrence after surgery.
SECONDARY OBJECTIVES:
- To develop and validate a clinically useful prognostic signature for stage 1A NSCLC (T1a-bN0M0) that accurately predicts the risk of post-operative cancer recurrence and is part of a prognostic classifier, which also includes histological, pathological, and demographic parameters as in the primary objective.
II. To determine the effects on test accuracy of the histological subtype (adenocarcinoma [AC] vs squamous cell [SQA]) for each of the stage specific prognostic classifiers.
III. To determine the relevant statistical features, including accuracy of predicting overall survival, cancer specific survival, and disease free survival at 3 and 5 years, for each of the prognostic classifiers validated.
IV. To utilize the validated prognostic signatures and classifiers in stage 1B NSCLC to determine whether these can reliably predict good outcome among stage II NSCLC patients.
OUTLINE:
RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression by Affymetrix microarrays (Gene Profiling Array cGMP U133 P2) and reverse transcriptase-polymerase chain reaction (RT-PCR).
- Conditions
- Lung Cancer
- Being tested
- laboratory biomarker analysis
- Keywords
- stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of 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
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-correlative (whole-genome expression) | RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression profiling by Gene Profiling Array cGMP U133 P2 and RT-PCR. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Measured: up to 36 months
Secondary outcomes (4)
Cancer specific survival
Measured: Up to 36 months
Disease-free survival
Measured: up to 36 months
Overall survival
Measured: up to 36 months
Probability of death due to other causes
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Raphael Bueno, MD, Study chair, Brigham and Women's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517971
- Sponsor's protocol ID
- CALGB-150807
- Other IDs
- CALGB-150807, CDR0000720368
- Status last verified
- Aug 2021
- First submitted
- 20 Jan 2012
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Bueno R, Richards WG, Harpole DH, Ballman KV, Tsao MS, Chen Z, Wang X, Chen G, Chirieac LR, Chui MH, Franklin WA, Giordano TJ, Govindan R, Joshi MB, Merrick DT, Rivard CJ, Sporn T, van Bokhoven A, Yu H, Shepherd FA, Watson MA, Beer DG, Hirsch FR. Multi-Institutional Prospective Validation of Prognostic mRNA Signatures in Early Stage Squamous Lung Cancer (Alliance). J Thorac Oncol. 2020 Nov;15(11):1748-1757. doi: 10.1016/j.jtho.2020.07.005. Epub 2020 Jul 24.
PubMed 32717408
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Molecular Prognostic Tests in NSCLC
- ClinicalTrials.gov ID
- NCT01517971
- Acronym / sponsor ID
- CALGB-150807
- Conditions
- Lung Cancer
- Keywords
- stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,060 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2012
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 25 Jan 2012 (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 biomarkers in predicting the risk of cancer returning after surgery in tissue samples of patients with early-stage non-small cell lung cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict how well patients will respond to treatment.
Detailed description
PRIMARY OBJECTIVES:
- To develop and validate a clinically useful molecular prognostic signature based on ribonucleic acid (RNA)-expression arrays to accurately distinguish between good and poor outcome in patients with stage 1B non-small cell lung cancer (NSCLC) (T2aN0M0) by predicting the risk of cancer recurrence after surgery.
SECONDARY OBJECTIVES:
- To develop and validate a clinically useful prognostic signature for stage 1A NSCLC (T1a-bN0M0) that accurately predicts the risk of post-operative cancer recurrence and is part of a prognostic classifier, which also includes histological, pathological, and demographic parameters as in the primary objective.
II. To determine the effects on test accuracy of the histological subtype (adenocarcinoma [AC] vs squamous cell [SQA]) for each of the stage specific prognostic classifiers.
III. To determine the relevant statistical features, including accuracy of predicting overall survival, cancer specific survival, and disease free survival at 3 and 5 years, for each of the prognostic classifiers validated.
IV. To utilize the validated prognostic signatures and classifiers in stage 1B NSCLC to determine whether these can reliably predict good outcome among stage II NSCLC patients.
OUTLINE:
RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression by Affymetrix microarrays (Gene Profiling Array cGMP U133 P2) and reverse transcriptase-polymerase chain reaction (RT-PCR).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (whole-genome expression) | – | Other: laboratory biomarker analysisRNA extracted from archived tumor tissue samples are analyzed for whole-genome expression profiling by Gene Profiling Array cGMP U133 P2 and RT-PCR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with NSCLC enrolled on the Cancer and Leukemia Group B (CALGB) 140202
Key inclusion criteria (4 listed)
- Registration to CALGB-140202
- The subject population to be studied in this protocol includes patients selected from CALGB-140202; all such patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into that trial; the CALGB does not require that a separate consent form be signed for this study
- All samples to be studied were obtained and stored as part of CALGB-140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
- Tumor specimens need to have 40% tumor content to be included
Key exclusion criteria (0 listed)
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 | Ancillary-correlative (whole-genome expression) |
Primary outcome
Recurrence
Time frame: up to 36 months
4 secondary outcomes
Cancer specific survival
Time frame: Up to 36 months
Disease-free survival
Time frame: up to 36 months
Overall survival
Time frame: up to 36 months
Probability of death due to other causes
Time frame: up to 36 months
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 17 Aug 2021.
- Derived from this study: PubMed 32717408Bueno R, Richards WG, Harpole DH, Ballman KV, Tsao MS, Chen Z, Wang X, Chen G, Chirieac LR, Chui MH, Franklin WA, Giordano TJ, Govindan R, Joshi MB, Merrick DT, Rivard CJ, Sporn T, van Bokhoven A, Yu H, Shepherd FA, Watson MA, Beer DG, Hirsch FR. Multi-Institutional Prospective Validation of Prognostic mRNA Signatures in Early Stage Squamous Lung Cancer (Alliance). J Thorac Oncol. 2020 Nov;15(11):1748-1757. doi: 10.1016/j.jtho.2020.07.005. Epub 2020 Jul 24.
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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.
Raphael Bueno, MD study chair
Brigham and Women's Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology 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 4 inclusion and 0 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 17 Aug 2021. 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 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?
Recurrence (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01517971, which also lists 1 linked publication.
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 17 Aug 2021.