Along with a pre-treatment and follow-up health history and demographic questionnaire, participants will perform one pre- treatment test for p53 oncoprotein immunohistochemistry with interpretation, comprehensive blood count with differential platelet, lipid panel, and comprehensive metabolic panel at Quest Labs, along with MRI. Other testing may occur according to the participants’ individual needs, but will not appear uniform for all participants.
The tumor suppressor gene, p53, is used as a biomarker for positive remission and non-recurrence of NSCLC pre- and post-treatment based on promising preclinical data. The test “p53 Oncoprotein Immunohistochemistry with Interpretation” will be utilized on a recurrent basis for at minimum 12 months post-treatment, as described above, for detection of overexpression and mutation.
“In a subgroup analysis of CALGB 9633, a phase III trial that randomized patients with stage IB NSCLC to observation or adjuvant chemotherapy, showed that p53 expression by immunohistochemistry (IHC) was detectable in 47% of tumors, and correlated with shorter disease-free survival (DFS) (Hazard ratio (HR) 1.95, P=0.003) and OS (HR 2.30, P=0.0005) in multivariate analyses.14 A meta-analysis of pooled patient data from 43 studies which included patients with ES-NSCLC who underwent potentially curative resection showed that p53 mutation or overexpression was an indicator of poor prognosis, especially in patients with adenocarcinoma (ADC). Compared to patients with no alterations, patients with ADC and p53overexpression or mutations had a 21.8% (P=0.0000039) and 48% (P=0.000031) reduction in 5-year OS respectively.15”
Data collected from all patients will be compared to a dataset compiled from 25 – 50 individuals of similar age and disease condition having received like treatment via standard chemotherapy, as a comparison model for determining overall efficacy of the CRISPR Rejuvenation Trials in Lung Cancer Elimination as separated from the standard efficacy rates of standard clinical practices for NSCLC treatment.
An identical process of historical, registry-based comparison will be used for a cohort of patients treated with immunotherapeutic treatments.