Non Small Cell Lung CancerFAHIC-LungNCT06196424
A Study to Investigate the Family History of Cancer in Patients With Non-small Cell Lung Cancer (FAHIC - Lung).
An observational study of Non Small Cell Lung Cancer, run by Fondazione Policlinico Universitario Campus Bio-Medico at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- study questionnaire to investigate family history
- How many people
- 336 participants
- Where
- 3 sitesItaly
- Study dates
- 2 Nov 2023to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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. Patients' 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.
Who may be able to join
- Histopathological diagnosis of Non-Small Cell Lung Cancer (all stages)
- Age ≥ 18 years old
- Signed informed consent
- Availability of familiar and/or personal anamnestic data of cancer
Who cannot join
- Unavailability of familiar and/or personal anamnestic data of cancer
- Patient's refusal
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
IRCCS Ospedale San Raffaele
Milan, 20132
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128
AOU Citta della Salute le Molinette
Torino, 10126
About this study
Official title: Observational, Prospective, Multicentre Study to Investigate the Family History of Cancer in Patients With Non-small Cell Lung Cancer (FAHIC - Lung).
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 14.9% 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.
Read more
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 tumours/primary 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 (active/passive, package/year, 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 translocation/gene fusions; Personal history of other synchronous/metachronous primary malignancies.
Read the 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 tumours/primary 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 patient's 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 (active/passive, package/year, 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 translocation/gene fusions.
Personal history of other synchronous/metachronous 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 professional/environmental carcinogens, segregate within the relatives with history of cancer.
The investigators will be able to describe whether recurrent family clusters of malignancies/risk 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 and/or 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 (i.e. especially enriched FHC with cases of cancer in both the collateral and lineal family lines) in up to the 6.8% 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 0.1 (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 (e.g. distribution of baseline characteristics according to the personal/familial 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; https://www.medcalc.org; 2021).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- study questionnaire to investigate family history
- Keywords
- family history of cancer, inherited risk, risk factors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study questionnaire to investigate family historyOther
Participants will be given a specific study questionnaire (paper-based) to fill at home, which was specifically designed to collect family history information
What is being measured
The primary outcome is the main question the study is designed to answer.
family history of cancer among participants
The study questionnaire will collect information on: family history of cancer, type of primary tumors among relatives and age at diagnosis, biological sex, exposure to tobacco smoking, geographical origin, potential professional and environmental exposure, ethnicity
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start2 Nov 2023
- Primary completion1 Mar 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza - Molinette Hospital, IRCCS San Raffaele
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196424
- Sponsor's protocol ID
- 27.23 CET 2 CBM
- Acronym
- FAHIC-Lung
- Status last verified
- May 2026
- First submitted
- 19 Dec 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared and there is no plan at this stage. Future requests will be considered upon reasonable requests. Fully anonymised data will be considered for sharing after assessment of the study PI, data protection office of the sponsor and with a data trasnfer agreement in place.
Publications
Stjepanovic N, Moreira L, Carneiro F, Balaguer F, Cervantes A, Balmana J, Martinelli E; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Hereditary gastrointestinal cancers: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-updagger. Ann Oncol. 2019 Oct 1;30(10):1558-1571. doi: 10.1093/annonc/mdz233. No abstract available.
PubMed 31378807Malvezzi M, Santucci C, Boffetta P, Collatuzzo G, Levi F, La Vecchia C, Negri E. European cancer mortality predictions for the year 2023 with focus on lung cancer. Ann Oncol. 2023 Apr;34(4):410-419. doi: 10.1016/j.annonc.2023.01.010. Epub 2023 Mar 6.
PubMed 36882139Steuer CE, Jegede OA, Dahlberg SE, Wakelee HA, Keller SM, Tester WJ, Gandara DR, Graziano SL, Adjei AA, Butts CA, Ramalingam SS, Schiller JH; ECOG-ACRIN 1505 Investigators. Smoking Behavior in Patients With Early-Stage NSCLC: A Report From ECOG-ACRIN 1505 Trial. J Thorac Oncol. 2021 Jun;16(6):960-967. doi: 10.1016/j.jtho.2020.12.017. Epub 2021 Feb 1.
PubMed 33539971Malhotra J, Malvezzi M, Negri E, La Vecchia C, Boffetta P. Risk factors for lung cancer worldwide. Eur Respir J. 2016 Sep;48(3):889-902. doi: 10.1183/13993003.00359-2016. Epub 2016 May 12.
PubMed 27174888Riudavets M, Garcia de Herreros M, Besse B, Mezquita L. Radon and Lung Cancer: Current Trends and Future Perspectives. Cancers (Basel). 2022 Jun 27;14(13):3142. doi: 10.3390/cancers14133142.
PubMed 35804914Cannon-Albright LA, Carr SR, Akerley W. Population-Based Relative Risks for Lung Cancer Based on Complete Family History of Lung Cancer. J Thorac Oncol. 2019 Jul;14(7):1184-1191. doi: 10.1016/j.jtho.2019.04.019. Epub 2019 May 7.
PubMed 31075544Ji J, Sundquist J, Sundquist K, Zheng G. Familial risk associated with lung cancer as a second primary malignancy in first-degree relatives. BMC Cancer. 2022 Oct 12;22(1):1057. doi: 10.1186/s12885-022-10149-7.
PubMed 36224547Chang ET, Smedby KE, Hjalgrim H, Glimelius B, Adami HO. Reliability of self-reported family history of cancer in a large case-control study of lymphoma. J Natl Cancer Inst. 2006 Jan 4;98(1):61-8. doi: 10.1093/jnci/djj005.
PubMed 16391372Murff HJ, Spigel DR, Syngal S. Does this patient have a family history of cancer? An evidence-based analysis of the accuracy of family cancer history. JAMA. 2004 Sep 22;292(12):1480-9. doi: 10.1001/jama.292.12.1480.
PubMed 15383520Cortellini A, Giusti R, Filetti M, Citarella F, Adamo V, Santini D, Buti S, Nigro O, Cantini L, Di Maio M, Aerts JGJV, Bria E, Bertolini F, Ferrara MG, Ghidini M, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Mazzoni F, Antonuzzo L, Gelibter A, Marchetti P, Chiari R, Macerelli M, Rastelli F, Della Gravara L, Gori S, Tuzi A, De Tursi M, Di Marino P, Mansueto G, Pecci F, Zoratto F, Ricciardi S, Migliorino MR, Passiglia F, Metro G, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Ficorella C, Porzio G, Tiseo M, Russano M, Russo A, Pinato DJ. High familial burden of cancer correlates with improved outcome from immunotherapy in patients with NSCLC independent of somatic DNA damage response gene status. J Hematol Oncol. 2022 Jan 21;15(1):9. doi: 10.1186/s13045-022-01226-2.
PubMed 35062993Benusiglio PR, Fallet V, Sanchis-Borja M, Coulet F, Cadranel J. Lung cancer is also a hereditary disease. Eur Respir Rev. 2021 Oct 20;30(162):210045. doi: 10.1183/16000617.0045-2021. Print 2021 Dec 31.
PubMed 34670806Sorscher S, LoPiccolo J, Heald B, Chen E, Bristow SL, Michalski ST, Nielsen SM, Lacoste A, Keyder E, Lee H, Nussbaum RL, Martins R, Esplin ED. Rate of Pathogenic Germline Variants in Patients With Lung Cancer. JCO Precis Oncol. 2023 Sep;7:e2300190. doi: 10.1200/PO.23.00190.
PubMed 37992258
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective, Multicentre Study to Investigate the Family History of Cancer in Patients With Non-small Cell Lung Cancer (FAHIC - Lung).
- ClinicalTrials.gov ID
- NCT06196424
- Acronym / sponsor ID
- FAHIC-Lung / 27.23 CET 2 CBM
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- family history of cancer, inherited risk, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza - Molinette Hospital, IRCCS San Raffaele
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 14.9% 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 tumours/primary 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 (active/passive, package/year, 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 translocation/gene fusions; Personal history of other synchronous/metachronous 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 tumours/primary 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 patient's 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 (active/passive, package/year, 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 translocation/gene fusions.
Personal history of other synchronous/metachronous 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 professional/environmental carcinogens, segregate within the relatives with history of cancer.
The investigators will be able to describe whether recurrent family clusters of malignancies/risk 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 and/or 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 (i.e. especially enriched FHC with cases of cancer in both the collateral and lineal family lines) in up to the 6.8% 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 0.1 (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 (e.g. distribution of baseline characteristics according to the personal/familial 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; https://www.medcalc.org; 2021).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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. Patients' 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.
Key inclusion criteria (4 listed)
- Histopathological diagnosis of Non-Small Cell Lung Cancer (all stages)
- Age ≥ 18 years old
- Signed informed consent
- Availability of familiar and/or personal anamnestic data of cancer
Key exclusion criteria (2 listed)
- Unavailability of familiar and/or personal anamnestic data of cancer
- Patient's refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| study questionnaire to investigate family historyParticipants will be given a specific study questionnaire (paper-based) to fill at home, which was specifically designed to collect family history information | Other | – |
Primary outcome
family history of cancer among participants
Time frame: through study completion, an average of 1 year
The study questionnaire will collect information on: family history of cancer, type of primary tumors among relatives and age at diagnosis, biological sex, exposure to tobacco smoking, geographical origin, potential professional and environmental exposure, ethnicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Results publication: PubMed 31378807Stjepanovic N, Moreira L, Carneiro F, Balaguer F, Cervantes A, Balmana J, Martinelli E; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Hereditary gastrointestinal cancers: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-updagger. Ann Oncol. 2019 Oct 1;30(10):1558-1571. doi: 10.1093/annonc/mdz233. No abstract available.
- Results publication: PubMed 36882139Malvezzi M, Santucci C, Boffetta P, Collatuzzo G, Levi F, La Vecchia C, Negri E. European cancer mortality predictions for the year 2023 with focus on lung cancer. Ann Oncol. 2023 Apr;34(4):410-419. doi: 10.1016/j.annonc.2023.01.010. Epub 2023 Mar 6.
- Results publication: PubMed 33539971Steuer CE, Jegede OA, Dahlberg SE, Wakelee HA, Keller SM, Tester WJ, Gandara DR, Graziano SL, Adjei AA, Butts CA, Ramalingam SS, Schiller JH; ECOG-ACRIN 1505 Investigators. Smoking Behavior in Patients With Early-Stage NSCLC: A Report From ECOG-ACRIN 1505 Trial. J Thorac Oncol. 2021 Jun;16(6):960-967. doi: 10.1016/j.jtho.2020.12.017. Epub 2021 Feb 1.
- Results publication: PubMed 27174888Malhotra J, Malvezzi M, Negri E, La Vecchia C, Boffetta P. Risk factors for lung cancer worldwide. Eur Respir J. 2016 Sep;48(3):889-902. doi: 10.1183/13993003.00359-2016. Epub 2016 May 12.
- Results publication: PubMed 35804914Riudavets M, Garcia de Herreros M, Besse B, Mezquita L. Radon and Lung Cancer: Current Trends and Future Perspectives. Cancers (Basel). 2022 Jun 27;14(13):3142. doi: 10.3390/cancers14133142.
- Results publication: PubMed 31075544Cannon-Albright LA, Carr SR, Akerley W. Population-Based Relative Risks for Lung Cancer Based on Complete Family History of Lung Cancer. J Thorac Oncol. 2019 Jul;14(7):1184-1191. doi: 10.1016/j.jtho.2019.04.019. Epub 2019 May 7.
- Results publication: PubMed 36224547Ji J, Sundquist J, Sundquist K, Zheng G. Familial risk associated with lung cancer as a second primary malignancy in first-degree relatives. BMC Cancer. 2022 Oct 12;22(1):1057. doi: 10.1186/s12885-022-10149-7.
- Results publication: PubMed 16391372Chang ET, Smedby KE, Hjalgrim H, Glimelius B, Adami HO. Reliability of self-reported family history of cancer in a large case-control study of lymphoma. J Natl Cancer Inst. 2006 Jan 4;98(1):61-8. doi: 10.1093/jnci/djj005.
- Results publication: PubMed 15383520Murff HJ, Spigel DR, Syngal S. Does this patient have a family history of cancer? An evidence-based analysis of the accuracy of family cancer history. JAMA. 2004 Sep 22;292(12):1480-9. doi: 10.1001/jama.292.12.1480.
- Results publication: PubMed 35062993Cortellini A, Giusti R, Filetti M, Citarella F, Adamo V, Santini D, Buti S, Nigro O, Cantini L, Di Maio M, Aerts JGJV, Bria E, Bertolini F, Ferrara MG, Ghidini M, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Mazzoni F, Antonuzzo L, Gelibter A, Marchetti P, Chiari R, Macerelli M, Rastelli F, Della Gravara L, Gori S, Tuzi A, De Tursi M, Di Marino P, Mansueto G, Pecci F, Zoratto F, Ricciardi S, Migliorino MR, Passiglia F, Metro G, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Ficorella C, Porzio G, Tiseo M, Russano M, Russo A, Pinato DJ. High familial burden of cancer correlates with improved outcome from immunotherapy in patients with NSCLC independent of somatic DNA damage response gene status. J Hematol Oncol. 2022 Jan 21;15(1):9. doi: 10.1186/s13045-022-01226-2.
- Results publication: PubMed 34670806Benusiglio PR, Fallet V, Sanchis-Borja M, Coulet F, Cadranel J. Lung cancer is also a hereditary disease. Eur Respir Rev. 2021 Oct 20;30(162):210045. doi: 10.1183/16000617.0045-2021. Print 2021 Dec 31.
- Results publication: PubMed 37992258Sorscher S, LoPiccolo J, Heald B, Chen E, Bristow SL, Michalski ST, Nielsen SM, Lacoste A, Keyder E, Lee H, Nussbaum RL, Martins R, Esplin ED. Rate of Pathogenic Germline Variants in Patients With Lung Cancer. JCO Precis Oncol. 2023 Sep;7:e2300190. doi: 10.1200/PO.23.00190.
- Individual participant dataSharing planned: No. IPD will not be shared and there is no plan at this stage. Future requests will be considered upon reasonable requests. Fully anonymised data will be considered for sharing after assessment of the study PI, data protection office of the sponsor and with a data trasnfer agreement in place.
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Fondazione Policlinico Universitario Campus Bio-Medico at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
family history of cancer among participants (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06196424, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.