GWA Study of Oral Cavity, Pharynx and Larynx Cancers in European, and North and South American Populations - CIDR

There is striking geographical variation in head and neck cancer (HNC) incidence globally. Some of the highest incidence rates have been observed in Southern and Eastern Europe and South America. The goal of this project is to assess susceptibility loci across and within ancestral backgrounds, using the All of Us array. Ten studies have come together in this initiative. ]]>
ARCAGE: Case Inclusion Criteria:All patients with a primary squamous cell carcinoma of the larynx, hypopharynx or oral cavity are confirmed by histology or cytology. We included the following topography codes from the International Classification of Diseases for Oncology, Third Edition (ICD-O-3)14: C320–C32.9 for larynx, C12.9 and C13.0–C13.9 for hypopharynx, and C00.3–C00.9, C02.0–C02.3, C03.0–C03.9, C04.0–C04.9, C05.0, and C06.0–C06.9 for oral cavity cancers. Control Inclusion Criteria: Frequency-matched by sex, 5-year age group, ethnicity, and residence areaInterCHANGE: First primary tumors of the head and neck with the ICD-O sites specified below are eligible for the study. These include the following ICD-O-3 codes and their subcategories [International Classification of Diseases for Oncology, Third Edition, World Health Organization, Geneva (2000)]: C00.3 to C00.9 Lip (excluding C00.0, C00.1 and C00.2 – external lip), C01 Base of the tongue, C02 Other and unspecified parts of the tongue, C03 Gum, C04 Floor of mouth, C05 Palate, C06 Other and unspecified parts of the mouth, C09 Tonsil, C10 Oropharynx, C12 Pyriform sinus, C13 Hypopharynx, C14 Other sites in lip, oral cavity and pharynx, and C32 LarynxSites not included are: cancers of the external lip (C00.0, C00.1, and C00.2), the salivary glands (C07-08), and the nasopharynx (C11)Control selection: Frequency-matched by sex, 5-year age group, ethnicity, and residence areaPopulation controls will be selected where this is feasible. Hospital controls chosen from list of acceptable diseasesVisitor controls are also acceptable.The proportion of hospital controls within a particular diagnostic group should not exceed 33%. Hospital controls should have been in hospital for less than 1 month when recruited. Controls will be selected from a strictly defined list of non-chronic diseases unrelated to alcohol, tobacco or dietary practices. This will include 1) endocrine and metabolic, 2) genito-urinary, 3) skin, subcutaneous tissue, and musculoskeletal disorders, 4) trauma, 5) gastro-intestinal, 6) circulatory disorders, 7) ear, eye and mastoid disorders, 8) plastic surgery cases, 9) nervous system diseases, 10) minor surgery, 11) ophthalmic and ear conditions, 11) lower back pain, and 12) urinary tract infection. EPIC: In the majority of study centers, subjects were invited from the general adult population residing in a given town or geographical area. There were, however, exceptions to this recruitment scheme. The French cohort was based on members of the health insurance for teachers (with the aim of facilitating follow-up for incidence of cancer and other diseases). Components of the Italian and Spanish cohorts included members of local blood donor associations. The cohorts in Utrecht (The Netherlands) and Florence (Italy) included women invited for a local population-based breast cancer screening program. In Oxford (UK), half of the cohort were recruited among subjects who did not eat meat, including vegans (who consume no animal products), lacto-ovo vegetarians and fish eaters (i.e. consumers of fish but not meat). In France, Norway, Utrecht (The Netherlands) and Naples (Italy), only women were recruited.SAS: Cases for study will consist of cases of invasive cancer with the following topographical characteristics according to the International Classification for Diseases for Oncology (ICD-O, Percy et al., 1990): C00 Lip (C00.0, C00.1 and C00.2, external, upper, lower and NOS lip are excluded), C01 Base of tongue, C02 Other and unspecified parts of tongue, C03 Gum, C04 Floor of mouth, C05 Palate, C06 Other and unspecified parts of mouth, C07 Parotid gland, C08 Other and unspecified major salivary glands, C09 Tonsil, C10 Oropharynx, C12 Pyriform sinus, C13 Hypopharynx, C14 Other sites in lip, oral cavity and pharynx, and C32 Larynx Subsets of cases will be analyzed separately. The two main groups of sites include oral cavity and oropharynx (C00-C10), and hypopharynx and larynx (C12, C13, C32). However, more specific subsets of cases (e.g. glottic cancers, code C32.0) can be identified for specific analyses. Newly diagnosed cases, aged between 15 and 79. Inclusion of cases aged 80 or over is optional. Cases might have been diagnosed for the first time outside the participating study hospitals as long as the referral to the participating hospital is for primary therapy, not previously treated (local as 16 well as systemic). They must not have undergone any previous local or systemic treatment (diagnostic biopsies excluded) for the current tumor. Cases must be histologically or cytologically confirmed. All histological types will be included; however, information on histological type will be collected and the largest series of types (e.g., squamous cell carcinoma) will be analyzed separately. Controls: group-matched by sex, age (in quinquennia) and center. Control subjects admitted as in-patients or out-patients in the same hospitals as the cases or in nearby hospitals which share, with the hospitals where cases have been identified, the same catchment area. No history or current suspicion of cancer of the larynx, the oral cavity, the pharynx or the esophagus. Diseases associated positively or negatively with the known or suspected risk factors for cancers of the oral cavity and the larynx will be excluded. CHANCE: Eligible tumor sites included ICD-O-3 topography codes C01.9 to C14.8 and C32.0 to C32.9. We excluded tumors of the lip (C0.00-C00.9), salivary glands (C07.9, C08.0-C08.9), nasopharynx (C11.0-C11.9), nasal cavity (C30.0), and nasal sinuses (C31.0-C31.9). Cases with carcinomas of other histologies, carcinomas at other head and neck sites, or a history of recurrent or second primary tumors were not eligible. Sudbury:Inclusion Criteria: Ever-smokers (identified by asking participants "have you ever smoked at least 100 cigarettes in your entire life?"), 18 years or older, capable of being able to read/write/understand English, and able to provide informed consent to participate in the study. Pathologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Patient is in receipt of curative intent radiotherapy (with or without chemotherapy) for their head and neck cancer, 18 years of age or older, and capable of providing informed consent.Exclusion Criteria: Patients with human immunodeficiency virus (HIV) or hepatitis C as pre-existing medical conditions at study enrollment. Known metastatic disease, prior receipt of EBRT to the head and neck, prior systemic chemotherapy (for any reason).IROPICAN:Case Inclusion Criteria: Patients 1) were of Iranian nationality, 2) age ranged between 30 to 75, and 3) had a pathology-confirmed cancer diagnosis. Case Exclusion Criteria: Patients with metastatic cancers, second primary cancers, and those with non-confirmed pathology report were excluded. Pregnant and nursing women were also not enrolled. The control group was selected from hospital visitors with no cancer diagnosis that was chosen from the relatives or friends of patients from non-oncology wards. Control participants were matched with cases for gender, age, and place of residence. UPitts:Case Inclusion Criteria: 18-80 years of age at diagnosis of primary head and neck cancer Pathology confirmed primary squamous cell cancer at a head and neck site Enrolled within one year of diagnosis No restrictions on sex/gender, race or ethnicity Control Inclusion Criteria: 18-80 years of age on date of enrollment No personal history of cancer at a head and neck site Without clinical suspicion of head and neck cancer based on clinical examination No restrictions on sex/gender, race or ethnicity HN:6:Disease characteristics:Histologically and/or cytologically confirmed (primary lesion or regional lymph nodes) squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynxLocally advanced disease, defined by any of the following criteria:Any T, N+, M0 T3-4, N0, M0No current history of unknown primary squamous cell carcinoma of the head and neck, primary nasopharyngeal, paranasal, or salivary gland tumors of the head and neckPatient characteristics: ECOG performance status 0-1 Absolute granulocyte count ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST or ALT ≤ 3 times ULN Creatinine clearance > 50 mL/min Magnesium > 0.5 mmol/L Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment Must be accessible for treatment and follow-up Able (sufficiently fluent) and willing to complete the quality of life (QOL) and swallowing QOL questionnaires in either English or French Must be assessed by a radiation oncologist and medical oncologist and deemed suitable for study participation No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, or other curatively treated solid tumors No history of allergic or hypersensitivity reactions to any of the study drugs or their excipients No prior or concurrent interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) on baseline CT scan No peripheral neuropathy ≥ grade 2 (CTCAE v3.0) No hearing loss/tinnitus ≥ grade 3 (CTCAE v3.0) No thromboembolic event within the past 12 months despite being treated with anticoagulation drugsPrior thromboembolic event > 12 months allowed provided patient is stable on anticoagulation or on preventative anticoagulationNone of the following allowed:Myocardial infarction within the past 12 monthsUncontrolled severe congestive heart failureUnstable anginaActive cardiomyopathyUnstable ventricular arrhythmiaUncontrolled hypertensionUncontrolled psychiatric disorderActive serious infectionActive peptic ulcer diseaseAny other medical condition that might interfere with protocol therapy deliveryPrior concurrent therapyNo prior surgical treatment except diagnostic biopsy for this disease No prior induction chemotherapy for this disease No prior radiation to the head and neck region that would result in overlap of fields for this study No prior cisplatin or carboplatin chemotherapy No prior targeted anti-EGFR therapy of any kind At least 30 days since any prior investigational agent No concurrent granulocytic growth factors, e.g., filgrastim (G-CSF), during radiotherapy No concurrent erythropoietic growth factors, pilocarpine, amifostine, other anticancer therapy (e.g., cytotoxic agents, biological response modifiers, immunotherapy, or hormonal therapy), or other investigational drug therapy The following radiological investigations must be done within 8 weeks of randomization:MRI or CT of the head and neckCT chestToronto:Case Inclusion Criteria: Residents of Ontario with histologically-confirmed diagnosis with primary head and neck cancerControl Inclusion Criteria: Residents of Ontario with no personal history of upper aero-digestive tract cancers ]]>
ARCAGE: In 2002, the IARC initiated the alcohol-related cancers and genetic susceptibility in Europe (ARCAGE) project with the participation of 15 centers in 11 European countries, namely, Zagreb (Croatia), Prague (Czech Republic), Tartu (Estonia), Paris (France), Bremen (Germany), Athens (Greece), Dublin (Ireland), Aviano, Padova and Turin (Italy), Oslo (Norway), Barcelona (Spain) and Glasgow, Manchester and Newcastle (UK). The specific aims of the study were to (i) investigate whether specific patterns and types of known etiological factors are particularly important, including specific type of alcohol consumption and patterns of drinking, (ii) study the role of dietary components and patterns with a focus on fruit and fresh vegetables as potentially protective, and pickled vegetables and meat as potentially detrimental, (iii) examine the interaction between high alcohol intake and dietary or other lifestyle factors, especially low consumption of fruits and vegetables, and tobacco consumption, (iv) investigate the role of genetic susceptibility to alcohol and tobacco metabolism and DNA damage in determining individual risk for UADT cancers, (v) investigate the role of human papilloma virus infection on UADT cancer risk, and (vi) undertake genome-wide association studies to identify genes related to UADT cancer risk. InterCHANGE: The InterCHANGE study is designed to better understand the role of HPV, genetics, tobacco and alcohol consumption in the etiology and clinical outcome of head and neck cancers (oral cavity, larynx, pharynx) in Latin American countries. The InterCHANGE study aims to recruit a large series of 2000 cases and 2000 controls from multiple centers in South America, which will make it the largest study of head and neck cancers in this population. This size will ensure accurate and robust findings on the role of HPV infection, genetic and lifestyle factors in both etiology and survival. SAS: International study of environment, viruses and cancer of the oral cavity and the larynx: Case-control design, conducted in five centers in Brazil (Pelotas, Porto Alegre, Goiânia, Rio de Janeiro, Sâo Paulo) and one center in Argentina (Buenos Aires) and coordinated by IARC. Cases and controls are interviewed with respect to their history of exposure to lifestyle and environmental factors. Exposure to occupational carcinogens will be assessed by teams of local experts. Samples of blood and oral mucosa cells will be obtained from cases and controls, and fresh or paraffin embedded tumor samples will be obtained from cases. Biological samples will be analyzed for presence of HPV, genetic polymorphism to metabolic enzymes and genetic alterations. EPIC: The European Prospective Investigation into Cancer and Nutrition (EPIC) is a prospective cohort with more than 521000 study participants enrolled from 23 centers in 10 western European countries. Detailed information on diet, lifestyle characteristics, anthropometric measurements, and medical history was collected at recruitment (1992—1999). Biological samples including plasma, serum, leukocytes, and erythrocytes were also collected at baseline from 387889 individuals and are stored at the International Agency for Research on Cancer – World Health Organization (IARC-WHO) and mirrored at EPIC collaborating centers. Overall, the EPIC biorepositories host more than 9 million aliquots, constituting one of the largest biobanks in the world for biochemical and genetic investigations on cancer and other chronic diseases. Follow-up measures of lifestyle exposures have been collected and centralized at IARC in 2019 (SOURCE: Background - EPIC_IARC).Sudbury: Head and neck cancer patients who were receiving treatment for their head and neck cancer and had a history of smoking participated in a study that examined smoking characteristics, intention to quit, and strategies to assist in smoking cessation. Patients who were current smokers were offered an intensive clinical tobacco intervention to assist with smoking cessation and were actively followed weekly during radiation treatment and then post-treatment at 6-months, 12-months, and for survivorship outcomes (PMID: 33173387). Head and neck cancer patients receiving external beam radiation therapy with curative intent completed questionnaires (EORTC, QLQ-C30 and QLQ-HN43) at baseline, mid-treatment, end of treatment, 5 weeks, 6-months, and 12-months post-treatment to assess treatment-related toxicity and treatment-related outcomes on quality of life and survivorship. IROPICAN (Iranian Opium and Cancer): This is a case-control study established in 2018 to evaluate the effects of opium use on developing lung cancer, bladder cancer, colorectal cancer and squamous cell carcinoma (SCC) of the head and neck within Iran. Participants were enrolled from 15 provinces in Iran that have a high rate of opium consumption. CHANCE: The Carolina Head and Neck Cancer Study (CHANCE) is a population-based case-control study of risk factors for head and neck cancer including 1,389 cases. In addition, data on treatment information and survival were obtained. CHANCE included cases, aged 20-80, who were residents of a 46-county region in North Carolina. Cases were first primary invasive SCCHN diagnosed between January 1, 2002 and February 28, 2006.UPitts: University of Pittsburgh case-control study on head and neck cancer and hospital-based case-control study. Head and neck squamous cell carcinoma (HNSCC) cases and controls were recruited from UPMC Otolaryngology clinics (Pittsburgh, PA) between August 2004 and July 2015. Cases were 18-80 years of age at diagnosis, and controls were subjects 18-80 years of age seeking treatment for non-malignant conditions who were free of HNSCC by clinical examination. Information on smoking, alcohol intake and other risk factors was collected via an interviewer-administered questionnaire, and clinical data including pathology and outcome information for cases was extracted from primary sources by certified cancer registrars. HN:6: This study is a multisite phase-III randomized clinical trial conducted at several participating sites in Ontario, Canada, between December 2008 and February 2017. Patients with locally advanced HNSCC of the oral cavity, oropharynx, larynx or hypopharynx were eligible to participate. The primary objective of this trial was to compare the progression free survival of patients with locally advanced SCCHN treated with standard fractionation radiotherapy and high dose cisplatin or accelerated fractionation radiotherapy and panitumumab. Toronto: The Mount Sinai Hospital-Princess Margaret Multicancer study (MSH-PMH) is a case-control study of upper aero-digestive tract cancer cases and healthy controls. The study is conducted at two adjacent partnering institutions, Sinai Health System and Princess Margaret Cancer Center in Toronto, Canada, and has been ongoing since October 2008. Cancer cases include adult patients diagnosed with primary malignant cancer of the upper aero-digestive tract, including lung and head and neck cancers (HNC). For this project, only HNC cases were included. Controls included in this project were part of the Ontario Population Genomics Platform, which were randomly selected from Ontario-based cohorts. ]]>