Pathogenic Variants in Genes Associated With Lung Adenocarcinoma

Status Recruiting

Clinical Trial Summary

The goal of this observational study is to describe the prevalence of germ line-pathogenic variants in Mexican patients with lung adenocarcinoma. The main questions it aims to answer are: 1. What is the prevalence of pathogenic variants in genes associated with lung adenocarcinoma in Mexican patients younger than fifty? 2. Which clinical-pathological characteristics are associated with germ-line pathogenic variants in patients with lung adenocarcinoma? 3. How actionable somatic mutations are associated with germ line-pathogenic variants of patients with lung adenocarcinoma? Participants will be asked to sign an informed consent; after that, they will be instructed to donate 10 ml of peripheral blood by venipuncture in the morning and before the patient has taken morning medication and the first meal, following a period of 8-12 hr fasting.

Clinical Trial Description

This is an observational, descriptive, and longitudinal study. The sample size was calculated with a proportion difference formula for a known population, considering the Local Institutional Personalized Medicine Laboratory tests 100 blood samples per year from patients with non-small cell lung cancer (NSCLC). It was considered a 95% confidence level and an 80% power. In addition, a 10% loss in follow-up was estimated. After reviewing the inclusion and exclusion criteria, signing the informed consent, and peripheral blood sampling. Total DNA (tDNA) will be extracted using the DNAeasy Blood & Tissue (Qiagen) kit. Likewise, for the determination of pathogenic variants, the Sophia HCS Community panels (Sophia genetics) will be used to carry out Next-generation (NGS) sequencing in a NextSeq 550 (Illumina) platform. To determine the clinical significance of genomic variants, the data analysis will be performed on the SOPHiA Alamut™ Visual Plus which is a comprehensive, full genome browser for efficient and user-friendly variant interpretation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06181812
Study type	Observational
Source	Instituto Nacional de Cancerologia de Mexico
Contact	Oscar G Arrieta Rodriguez, M.D., M.Sc.
Phone	5556280400
Email	ogar@unam.mx
Status	Recruiting
Phase
Start date	December 15, 2022
Completion date	December 15, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02898857` - Chemoresistance and Involvement of the NOTCH Pathway in Patients With Lung Adenocarcinoma	N/A
Completed	`NCT02127359` - Whole-Exome Sequencing (WES) of Cancer Patients
Recruiting	`NCT01249066` - Expression of AMP-activated Protein Kinase (AMPK) Protein in Lung Adenocarcinoma	N/A
Not yet recruiting	`NCT04482829` - TCM in the Treatment of Lung Adenocarcinoma	N/A
Recruiting	`NCT04929041` - Testing the Addition of Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative	Phase 2/Phase 3
Terminated	`NCT04691375` - A Study of PY314 in Subjects With Advanced Solid Tumors	Phase 1
Terminated	`NCT02621333` - Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma	Phase 2
Active, not recruiting	`NCT02282267` - Blood Detection of EGFR Mutation For Iressa Treatment	N/A
Not yet recruiting	`NCT01942629` - Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas	N/A
Recruiting	`NCT01482585` - Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy	N/A
Recruiting	`NCT03376737` - Study of Apatinib as the Maintenance Therapy in Advanced Lung Adenocarcinoma	Phase 2
Recruiting	`NCT05537922` - I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
Recruiting	`NCT04937283` - Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm	N/A
Recruiting	`NCT06255197` - Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers
Completed	`NCT02093000` - A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung Adenocarcinoma	N/A
Recruiting	`NCT04119024` - Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors	Phase 1
Terminated	`NCT04682431` - A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors	Phase 1
Recruiting	`NCT05736991` - Deep Learning Signature for Predicting the Novel Grading System of Clinical Stage I Lung Adenocarcinoma
Enrolling by invitation	`NCT05136014` - Evaluation of the Response to Tyrosine Kinase Inhibitors in Localized Non-small Cell Lung Cancer (NSCLC) Patients With EGFR Mutation in a Patient-derived Organoid Model
Terminated	`NCT05012397` - Milademetan in Advanced/Metastatic Solid Tumors	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.