A Study to Investigate the Family History of Cancer in Patients With Non-small Cell Lung Cancer (FAHIC - Lung).

NCT06196424 | Recruiting

• 1 other identifier: 27.23 CET 2 CBM
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 3

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 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

Non Small Cell Lung Cancer

Keywords

family history of cancer; inherited risk; risk factors

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 1 year

Interventions

study questionnaire to investigate family history OTHER

Participants will be given a specific study questionnaire (paper-based) to fill at home, which was specifically designed to collect family history information

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Unavailability of familiar and/or personal anamnestic data of cancer
• Patient's refusal

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead
• A.O.U. Città della Salute e della Scienza - Molinette Hospital: collaborator
• IRCCS San Raffaele: collaborator

Study Sites (3)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

RECRUITING

AOU Citta della Salute le Molinette

Torino, 10126, Italy

NOT YET RECRUITING

Related Publications (12)

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  PMID: 31378807 RESULT

• Malvezzi 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 RESULT

• Steuer 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 RESULT

• Malhotra 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 RESULT

• Riudavets 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 RESULT

• Cannon-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 RESULT

• Ji 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.

  PMID: 36224547 RESULT

• Chang 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.

  PMID: 16391372 RESULT

• Murff 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.

  PMID: 15383520 RESULT

• Cortellini 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.

  PMID: 35062993 RESULT

• Benusiglio 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.

  PMID: 34670806 RESULT

• Sorscher 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.

  PMID: 37992258 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Alessio Cortellini, MD PhD

CONTACT

0039 06 22541 1; a.cortellini@policlinicocampus.it

Fabrizio Citarella, MD

CONTACT

0039 06 22541 1; f.citarella@policlinicocampus.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 9, 2024
• Study Start: November 2, 2023
• Primary Completion: March 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)