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| Status |
Public on Aug 28, 2020 |
| Title |
Multi-institutional prospective validation of prognostic mRNA signatures in early stage squamous lung cancer (Alliance) [cohort I] |
| Organism |
Homo sapiens |
| Experiment type |
Expression profiling by array
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| Summary |
Purpose: The primary objective of the current study was to validate biomarkers to identify the 10% to 27% of patients with stage I and 35% of patients with stage IIA squamous cell carcinoma of lung (SC) who are likely to recur following surgical resection, so that these patients may be offered enrollment in clinical trials evaluating directed ACT. A secondary objective was to identify patients with stage IIB SC who are unlikely to develop recurrences and might thereby be spared the potential significant toxicity and expense of ACT.
Methods: Two-stage validation used independent core laboratories, objective quality control standards, locked test parameters, and large multi-institutional specimen/data sets. First stage validation confirmed a signature’s ability to stratify patient survival. Second stage validation determined which signature(s) optimally improved risk discrimination when added to baseline clinical predictors. Participants were prospectively enrolled on institutional (Cohort I) or cooperative group (Cohort II) biospecimen/data collection protocols. All cases underwent central review of clinical, pathologic and biospecimen parameters using objective criteria to determine final inclusion (Cohort I: n=249; Cohort II: n=234). Primary selection required that a signature significantly predict 3-years survival after surgery in Cohort I. Signatures meeting this criterion were further tested in Cohort II, comparing risk prediction using baseline risk factors alone versus in combination with the signature.
Results: Male sex, advanced age, and higher stage were associated with shorter survival in Cohort I and established a baseline clinical model. Of three signatures validated in Cohort I, one signature was validated in Cohort II and statistically significantly enhanced prognosis relative to the baseline model (C-index difference 0.122; p<0.05).
Conclusions: These results represent the first rigorous validation of a test appropriate to direct adjuvant treatment or clinical trials for patients with lung squamous cell carcinoma.
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| Overall design |
Total RNA from squamous cell carcinoma specimens were extracted for mRNA profiling with microarray analysis.
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| Contributor(s) |
Bueno R, Richards WG, Harpole DH, Ballman KV, Tsao M, Chen Z, Wang X, Chen G, Chirieac LR, Chui MH, Franklin WA, Giordano TJ, Govindan R, Joshi M, Merrick DT, Rivard CJ, Sporn T, van Bokhoven A, Yu H, Shepherd FA, Watson MA, Beer DG, Hirsch FR |
| Citation(s) |
32717408 |
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| Submission date |
Aug 27, 2020 |
| Last update date |
Dec 26, 2020 |
| Contact name |
Zhengming Chen |
| E-mail(s) |
zhc2006@med.cornell.edu
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| Phone |
6469628015
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| Organization name |
Weill Cornell Medicine
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| Street address |
402 67th street
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| City |
New York |
| State/province |
NY |
| ZIP/Postal code |
10065 |
| Country |
USA |
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| Platforms (1) |
| GPL570 |
[HG-U133_Plus_2] Affymetrix Human Genome U133 Plus 2.0 Array |
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| Samples (249)
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| This SubSeries is part of SuperSeries: |
| GSE157011 |
Multi-institutional prospective validation of prognostic mRNA signatures in early stage squamous lung cancer (Alliance) |
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| Relations |
| BioProject |
PRJNA659855 |
| Supplementary data files not provided |
| Processed data included within Sample table |
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