Pathogenic Variants in Genes Associated With Lung Adenocarcinoma
ConditionLung Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-85
SponsorOscar Gerardo Arrieta Rodríguez
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Both sexes
≥ 16 years old, according the institutional protocols for new patients admittances.
histologically confirmed lung adenocarcinoma (LUAD)
Signed written informed consent form
Disqualifiers
A sample of peripheral blood that is not accessible.
Insufficient clinical pathological information in the electronic clinical record.
Withdrawal
Insufficient DNA quality and quantity for genomic sequencing analyses.
Trial population
Patients with lung adenocarcinoma treated in the Thoracic Oncology Unit of the National Institute of Cancer.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
PV in patients with lung carcinoma
To determine the prevalence of pathogenic variants (PV) in patients with lung adenocarcinoma through amplicon next-generation sequencing (NGS).
Time frame
One peripherial blood sample (day 1) at baseline of study.Secondary outcomes
1
OS
To evaluate the prognostic impact of the pathogenic variants (PV) in the overall survival (OS) of patients with lung carcinoma.
Time frame
From date of confirmed diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months2
PFS
To evaluate the prognostic impact of the pathogenic variants (PV) in the progression free survival (PFS) of patients with lung carcinoma.
Time frame
From date of first line of treatment initiation (guided therapy) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oscar Gerardo Arrieta Rodríguez
Lead sponsor
Instituto Nacional de Cancerologia de Mexico
Sponsor institution
Source ClinicalTrials.gov