Clinical trial · Observational
A Study to Investigate the Family History of Cancer in Patients With Non-small Cell Lung Cancer (FAHIC - Lung).
Observational, Prospective, Multicentre Study to Investigate the Family History of Cancer in Patients With Non-small Cell Lung Cancer (FAHIC - Lung).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| study questionnaire to investigate family history | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- family history of cancer among participants
- timeFrame
- through study completion, an average of 1 year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Unavailability of familiar and/or personal anamnestic data of cancer * Patient's refusal
References
Publications (12)
- RESULTStjepanovic 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. PMID 31378807
- RESULTMalvezzi 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. PMID 36882139
- RESULTSteuer 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. PMID 33539971
- RESULTMalhotra 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. PMID 27174888
- RESULTRiudavets 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. PMID 35804914
- RESULTCannon-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. PMID 31075544
- RESULTJi 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.