Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06196424
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-19
Brief Title:
A Study to Investigate the Family History of Cancer in Patients With Non-small Cell Lung Cancer FAHIC - Lung
Sponsor:
Fondazione Policlinico Universitario Campus Bio-Medico
Organization:
Fondazione Policlinico Universitario Campus Bio-Medico
Study Overview
Official Title:
Observational Prospective Multicentre Study to Investigate the Family History of Cancer in Patients With Non-small Cell Lung Cancer FAHIC - Lung
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAHIC-Lung
Brief Summary:
Germline testing to find genetic alteration that can be linked to inherited susceptibility of developing the disease is recommended for patients diagnosed with certain solid cancers such as breast prostate and ovarian due to strong association with inheritable mutations implying familiar counselling Non-Small Cell Lung Cancer NSCLC is the leading cancer-related cause of death and smoking habitude is the main modifiable risk while environmental factors such as radon asbestosis and fine polluting particles account for most diagnoses among never or light smokers At the same time the relative risk RR of lung cancer correlates with the number of relatives diagnosed with lung cancer
A recent study of 7788 patients with NSCLC who receiving a germline testing described a prevalence of genetic alterations linked to inherited susceptibility of cancer in 149 of cases highlighting the potential role of genetic However all the available studies investigating the family history of cancer among patients with NSCLC are retrospective and do not consider modifiable risk factors such as smoking working habits and geographical origins
The objective of this study is the detailed description of the family history of cancer among patients with NSCLC and the description of distribution of other risk factors such as smoking among the study participants in order to establish whether there are specific family history clusters that can help clinicians in directing patients to genetic counselling
The study will enrol consecutive patients with NSCLC independently from age disease stage smoking status and clinic-pathological characteristics
Participants will provide clinical anamnestic information filling an ad hoc self-reported study questionnaire internally validated by the genetic expert of the steering committee Data of interest include Family history of cancer Type of tumoursprimary tumour site among relatives with history of cancer Age at diagnosis among relatives with history of cancer Biological sex of relatives with history of cancer Exposure to tobacco smoking and smoking habits among relatives with history of cancer Geographical origin of participants and relatives with history of cancer Personal history of multiple malignancies Potential professional and environmental exposure to carcinogens of participants and relatives with history of cancer Ethnicity of both participants and relatives with history of cancer
The study does not require any additional hospital access from the patients since the questionnaire will be returned at the following planned clinical consultation to minimize recall bias
The investigators will collect the following clinic-pathologic characteristics Smoking status activepassive packageyear total years of smoking Eastern Cooperative Oncology Group Performance Status ECOG-PS Age at diagnosis Tumour histology Tumour stage at diagnosis according to the 8th edition of TNM staging system Ethnicity Professional and environmental exposure to carcinogens Programmed death ligand-1 tumour proportion score PD - L1 TPS Any available oncogenic drivers including epidermal growth factor receptor EGFR Kirsten rat sarcoma virus KRAS BRAF c-MET mutations and Anaplastic lymphoma kinase ALK ROS-1 RET neurotrophic tyrosine receptor kinase NTRK translocationgene fusions Personal history of other synchronousmetachronous primary malignancies
A recent study of 7788 patients with NSCLC who receiving a germline testing described a prevalence of genetic alterations linked to inherited susceptibility of cancer in 149 of cases highlighting the potential role of genetic However all the available studies investigating the family history of cancer among patients with NSCLC are retrospective and do not consider modifiable risk factors such as smoking working habits and geographical origins
The objective of this study is the detailed description of the family history of cancer among patients with NSCLC and the description of distribution of other risk factors such as smoking among the study participants in order to establish whether there are specific family history clusters that can help clinicians in directing patients to genetic counselling
The study will enrol consecutive patients with NSCLC independently from age disease stage smoking status and clinic-pathological characteristics
Participants will provide clinical anamnestic information filling an ad hoc self-reported study questionnaire internally validated by the genetic expert of the steering committee Data of interest include Family history of cancer Type of tumoursprimary tumour site among relatives with history of cancer Age at diagnosis among relatives with history of cancer Biological sex of relatives with history of cancer Exposure to tobacco smoking and smoking habits among relatives with history of cancer Geographical origin of participants and relatives with history of cancer Personal history of multiple malignancies Potential professional and environmental exposure to carcinogens of participants and relatives with history of cancer Ethnicity of both participants and relatives with history of cancer
The study does not require any additional hospital access from the patients since the questionnaire will be returned at the following planned clinical consultation to minimize recall bias
The investigators will collect the following clinic-pathologic characteristics Smoking status activepassive packageyear total years of smoking Eastern Cooperative Oncology Group Performance Status ECOG-PS Age at diagnosis Tumour histology Tumour stage at diagnosis according to the 8th edition of TNM staging system Ethnicity Professional and environmental exposure to carcinogens Programmed death ligand-1 tumour proportion score PD - L1 TPS Any available oncogenic drivers including epidermal growth factor receptor EGFR Kirsten rat sarcoma virus KRAS BRAF c-MET mutations and Anaplastic lymphoma kinase ALK ROS-1 RET neurotrophic tyrosine receptor kinase NTRK translocationgene fusions Personal history of other synchronousmetachronous primary malignancies
Detailed Description:
This is a prospective observational multi-centre study Our study population will be represented by consecutive patients with histologically diagnosed NSCLC regardless of their age TNM stage smoking status and other clinic-pathologic characteristics
The primary objectives of this study will be
description of the FHC and potential within-family clusters of other risk factors among patients with NSCLC
identification of potential FHC patterns and within-family clusters of other risk factors to address patient with NSCLC to systematic genetic counselling
Secondary objectives include
- description of clinic-pathological and oncological characteristics of patients with NSCLC of according to FHC patterns and within-family clusters of other risk factors
Participants history will be carefully collected by investigators through a dedicated self-reported study questionnaire which has been developed for the purpose of this study provided as Appendix 1 The ad-hoc study questionnaire has been validated by the genetic expert of the steering committee who will train each investigator to translate the returned questionnaire into standardized family trees
Study questionnaire will focus on
Family history of cancer
Type of tumoursprimary tumour site among relatives with history of cancer
Age at diagnosis among relatives with history of cancer
Biological sex of relatives with history of cancer
Exposure to tobacco smoking and smoking habits among relatives with history of cancer
Geographical origin of participants and relatives with history of cancer
Personal history of multiple malignancies
Potential professional and environmental exposure to carcinogens of participants and relatives with history of cancer
Ethnicity of both participants and relatives with history of cancer
To minimize risks of recalling bias patients will be followed up for 4 weeks through 2 study visits the first study visit at enrolment and the follow-up study visit
During the first study visit all patients clinic-pathologic will be collected and study participants will be given the ad-hoc questionnaire which will be returned to the study personnel at the follow-up study visit
The following clinic-pathologic characteristics will be collected
Smoking status activepassive packageyear total years of smoking
Eastern Cooperative Oncology Group Performance Status ECOG-PS
Age at diagnosis
Tumour histology
Tumour stage at diagnosis according to the 8th edition of TNM staging system
Ethnicity
Professional and environmental exposure to carcinogens
Programmed death ligand-1 tumour proportion score PD - L1 TPS
Any available oncogenic drivers including epidermal growth factor receptor EGFR Kirsten rat sarcoma virus KRAS BRAF c-MET mutations and Anaplastic lymphoma kinase ALK ROS-1 RET neurotrophic tyrosine receptor kinase NTRK translocationgene fusions
Personal history of other synchronousmetachronous primary malignancies
Study data will be collected through dedicated electronic case report form e-CRF A full list of information that will be collected through the dedicated eCRF provided as appendix 2
Even though no established FHC criteria exists to refer patients with NSCLC to a genetic counselling for germ-line testing investigators will assess participant questionnaire at the follow-up study visit and refer patients to genetic counselling when clinically indicated as per local routine practice
Following collection of participants questionnaires the investigators will be able to reconstruct patients family three with additional information on how other potential risk factors such as history of smoking exposure to professionalenvironmental carcinogens segregate within the relatives with history of cancer
The investigators will be able to describe whether recurrent family clusters of malignanciesrisk factors are specifically associated with risk of lung cancer in order to individuate patients to specifically address to systematic genetic counselling to assess eligibility for germ-line testing in clinical practice Secondly the investigators will also assess the distribution of participants clinic-pathologic characteristics to assess whether any patients andor tumour-related feature is associated with patterns of FHC and within-family clustering of other risk factors
The esteemed study duration is 24 months Enrolment will start after protocol approval and will last for 12 months Data analysis will last 12 months from the closure of data collection
Statistical Plan and Sample Size
Given the descriptive nature of the study and the lack of available data on the relationship between family history of cancer and NSCLC the minimum sample size for the study has been established on the only study available to date which investigated distribution of FHC among unselected patients with stage IV NSCLC which described a high familiar burden of cancer ie especially enriched FHC with cases of cancer in both the collateral and lineal family lines in up to the 68 of patients 14 On the basis of this data the investigators hypothesized a prevalence of 10 of participants with an especially enriched family history of cancer in our study population assuming a confidence level of 95 with a total width for the confidence interval of 01 precision of - 5 and considering a 10 drop out the minimum number of subjects that will need to be enrolled to properly describe the group of interest following a binomial exact calculation of the sample size is 175 Descriptive statistics will be used as appropriate to report FHC data distribution of within-family other risk factors and baseline clinic-pathologic characteristics The Fisher exact test and the χ2 test will be used as appropriate to compare categorical variables eg distribution of baseline characteristics according to the personalfamilial positive or negative history Analyses were performed using the R-studio software R Core Team 2021 R A language and environment for statistical computing R Foundation for Statistical Computing Vienna Austria and the MedCalc Statistical Software version 20 MedCalc Software Ltd Ostend Belgium httpswwwmedcalcorg 2021
The primary objectives of this study will be
description of the FHC and potential within-family clusters of other risk factors among patients with NSCLC
identification of potential FHC patterns and within-family clusters of other risk factors to address patient with NSCLC to systematic genetic counselling
Secondary objectives include
- description of clinic-pathological and oncological characteristics of patients with NSCLC of according to FHC patterns and within-family clusters of other risk factors
Participants history will be carefully collected by investigators through a dedicated self-reported study questionnaire which has been developed for the purpose of this study provided as Appendix 1 The ad-hoc study questionnaire has been validated by the genetic expert of the steering committee who will train each investigator to translate the returned questionnaire into standardized family trees
Study questionnaire will focus on
Family history of cancer
Type of tumoursprimary tumour site among relatives with history of cancer
Age at diagnosis among relatives with history of cancer
Biological sex of relatives with history of cancer
Exposure to tobacco smoking and smoking habits among relatives with history of cancer
Geographical origin of participants and relatives with history of cancer
Personal history of multiple malignancies
Potential professional and environmental exposure to carcinogens of participants and relatives with history of cancer
Ethnicity of both participants and relatives with history of cancer
To minimize risks of recalling bias patients will be followed up for 4 weeks through 2 study visits the first study visit at enrolment and the follow-up study visit
During the first study visit all patients clinic-pathologic will be collected and study participants will be given the ad-hoc questionnaire which will be returned to the study personnel at the follow-up study visit
The following clinic-pathologic characteristics will be collected
Smoking status activepassive packageyear total years of smoking
Eastern Cooperative Oncology Group Performance Status ECOG-PS
Age at diagnosis
Tumour histology
Tumour stage at diagnosis according to the 8th edition of TNM staging system
Ethnicity
Professional and environmental exposure to carcinogens
Programmed death ligand-1 tumour proportion score PD - L1 TPS
Any available oncogenic drivers including epidermal growth factor receptor EGFR Kirsten rat sarcoma virus KRAS BRAF c-MET mutations and Anaplastic lymphoma kinase ALK ROS-1 RET neurotrophic tyrosine receptor kinase NTRK translocationgene fusions
Personal history of other synchronousmetachronous primary malignancies
Study data will be collected through dedicated electronic case report form e-CRF A full list of information that will be collected through the dedicated eCRF provided as appendix 2
Even though no established FHC criteria exists to refer patients with NSCLC to a genetic counselling for germ-line testing investigators will assess participant questionnaire at the follow-up study visit and refer patients to genetic counselling when clinically indicated as per local routine practice
Following collection of participants questionnaires the investigators will be able to reconstruct patients family three with additional information on how other potential risk factors such as history of smoking exposure to professionalenvironmental carcinogens segregate within the relatives with history of cancer
The investigators will be able to describe whether recurrent family clusters of malignanciesrisk factors are specifically associated with risk of lung cancer in order to individuate patients to specifically address to systematic genetic counselling to assess eligibility for germ-line testing in clinical practice Secondly the investigators will also assess the distribution of participants clinic-pathologic characteristics to assess whether any patients andor tumour-related feature is associated with patterns of FHC and within-family clustering of other risk factors
The esteemed study duration is 24 months Enrolment will start after protocol approval and will last for 12 months Data analysis will last 12 months from the closure of data collection
Statistical Plan and Sample Size
Given the descriptive nature of the study and the lack of available data on the relationship between family history of cancer and NSCLC the minimum sample size for the study has been established on the only study available to date which investigated distribution of FHC among unselected patients with stage IV NSCLC which described a high familiar burden of cancer ie especially enriched FHC with cases of cancer in both the collateral and lineal family lines in up to the 68 of patients 14 On the basis of this data the investigators hypothesized a prevalence of 10 of participants with an especially enriched family history of cancer in our study population assuming a confidence level of 95 with a total width for the confidence interval of 01 precision of - 5 and considering a 10 drop out the minimum number of subjects that will need to be enrolled to properly describe the group of interest following a binomial exact calculation of the sample size is 175 Descriptive statistics will be used as appropriate to report FHC data distribution of within-family other risk factors and baseline clinic-pathologic characteristics The Fisher exact test and the χ2 test will be used as appropriate to compare categorical variables eg distribution of baseline characteristics according to the personalfamilial positive or negative history Analyses were performed using the R-studio software R Core Team 2021 R A language and environment for statistical computing R Foundation for Statistical Computing Vienna Austria and the MedCalc Statistical Software version 20 MedCalc Software Ltd Ostend Belgium httpswwwmedcalcorg 2021
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None