Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Breast Neoplasms

Melanoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Neoplasms, Unknown Primary

Carcinoma

Colorectal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Urogenital Neoplasms

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Neoplasm Metastasis

Neoplastic Processes

Neuroendocrine Tumor

Neuroepithelioma

Advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas; as well as patients who are phase I trial candidates

Philippe Bedard, MD

Substantial progress has been made in the treatment of cancer through the use of targeted therapies, but what works for one patient might not work for another patient. Certain drugs are now being developed that target specific molecules in the body that are believed to be part of the disease.

Biomarkers are specific characteristics of the cancer that may help provide prognostic information (i.e. how well patients will be regardless of the treatments given) or help predict sensitivity or resistance to a specific treatment.

The study will collect archival tumor samples (previously collected biopsy or surgical tumor samples) to provide biomarker data about a patient's cancer, in order to help their physicians to identify which clinical trials of molecularly targeted therapies may be most appropriate for the patient in the future.

The increasing appreciation and identification of specific somatic mutations and other genetic aberrations that drive cancers leave us on the threshold of a new era of "personalized cancer medicine", in which specific biomarkers will be used to direct targeted agents only to those patients deemed most likely to respond. The potential medical, scientific and economic benefits of such a personalized approach to cancer therapy are immense and self-evident. Yet despite some important advances, only a limited number of approved targeted agents have had their approvals predicated on specific biomarkers of sensitivity or resistance.

The premises behind personalized cancer medicine include: i) genetic aberrations exist in human malignancies; ii) a subset of these aberrations, often present across multiple cancer types, have functional relevance as "hallmarks" or "drivers" for oncogenesis and tumor progression; iii) such genetic aberrations are potentially "druggable" targets; and iv) there are tolerable medicinal compounds that can effectively modulate such targets. A key requirement of this new, personalized approach to anti-cancer therapy is that specific patients must be matched to a particular drug or combination of drugs. Molecular profiling of tumors to identify somatic mutations and/or other genetic aberrations are examples of enrichment strategies to assist in matching patients to drugs or treatments that have gained increasing interest in the oncology community.

The present protocol seeks to provide molecular profiling data to the treating physician for patients with advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas, as well as patients who are phase I trial candidates, in order to help identify which standard regimens or clinical trials of molecularly targeted therapies may be most appropriate for the individual patient.

Archival tumor tissue

1 tube of whole blood

Integrated Molecular Profiling in Advanced Cancers Trial

Genotyping assays including: AKT1, HRAS, AKT2, JAK2, AKT3, KIT, BRAF, KRAS, CDK, MEK1, CTNNB1, MET, EGFR, NOTCH1, ERBB2, NRAS, FGFR1, PDGFRA, FGFR2, PIK3CA, FGFR3, RET, FGFR4, SMO, STK11

Including utilization of information for standard regimens or clinical trials of molecularly targeted therapies.

Princess Margaret Hospital, Canada

University Health Network, Toronto

Substance Related Disorders

Behaviors and Mental Disorders

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Alcoholism

Behavior, Addictive

Mouth Neoplasms

Laryngeal Diseases

Laryngeal Neoplasms

Pharyngeal Neoplasms

Mouth Diseases

Stomatognathic Diseases

Otorhinolaryngologic Neoplasms

Otorhinolaryngologic Diseases

Pharyngeal Diseases

Esophageal Cancer

Oral Cancer

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years

Stéphane TEMAM, PhD

Randomized multicenter trial to assess the impact of a screening program for heavy alcohol drinkers and smokers treated in alcohol addiction clinics on upper aerodigestive tract cancer mortality.

Upper aerodigestive tract (UADT) carcinomas (oral cavity and pharynx (63%), larynx (17%) and esophagus (20%)), are frequent in France with 25.000 new cases annually estimated in 2000, representing 13% of men cancer (3rd rank). Five-year specific survival rate is approximately 50% (11.000 deaths per year) and has not improved in over three decades, primarily due to the advanced stage at presentation. UADT cancers are also associated with profound disease- and treatment-related morbidity, with alterations in speech and feeding functions, aesthetic disability, with familial and social consequences.

The high-risk population is well characterized. A synergistic effect of tobacco smoking and alcohol drinking increases the risk of developing a carcinoma by more than 100 fold. Each year, 30.000 alcohol drinkers are treated in alcohol addiction clinics and could benefit from cancer detection. Nonrandomized pilot studies have showed that a UADT cancers screening trial could be undertaken in these clinics.

Study design: prospective randomized trial comparing an observation group and a screening group. Subjects in the screening group will undergo annual screening test including head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy with cytological examination during a 3-years period. In case of a positive test, patients will undergo head and neck panendoscopy and/or digestive flexible endoscopy and/or biopsy. After the screening period, subjects will be followed during 2 additional years by annual health questionnaires. Subjects of the observation group will be followed during 5 years by annual health questionnaires. Recruitment will be performed in alcohol addiction clinics and screening tests and confirmation exams in the closest specialized head and neck clinics.

The primary objective is to demonstrate a decrease in the UADT cancer mortality after a screening strategy, including head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy with cytological examination repeated annually during 3 years. Subjects will be followed during 5 years. A sample size of 10.000 subjects in each group allows the detection of a 33% reduction in the specific mortality rate, with a power of 80% and with a one sided a-risk of 5%.

Randomized Trial to Assess the Impact of a Screening Program on Upper Aerodigestive Tract Cancer Mortality in a High Risk Population

DEPISTORL - THANCS (Trial of Head And Neck Cancer Screening) Randomized Multicenter Trial to Assess the Impact of a Screening Program for Heavy Alcohol Drinkers and Smokers Treated in Alcohol Addiction Clinics on Upper Aerodigestive Tract Cancer Mortality.

Gustave Roussy, Cancer Campus, Grand Paris

Patients will receive standard care, recommendations on physical activity.

patients should wear the wristband continuously for 7 days prior to scheduled hospital visit T0, T1, T2, T3, T4, T5

1 or 2 physical activity sessions per week, either face-to-face or by videoconference at patient convenience: low-to-moderate intensity aerobic and anaerobic muscle-strengthening session and a 40-minute stretching/yoga session.

patients should wear the wristband continuously for 7 days prior to scheduled hospital visit T0, T1, T2, T3, T4, T5

International Physical Activity (IPAQ) Questionnaire, Quality of Life Questionnaire QLQ-C30, HN 43 questionnaire, Multidimensional Fatigue Inventory (MFI) Questionnaire, Big Five Inventory Questionnaire, illness Identity Questionnaire,

behavioral

Actimetry (cumulative time without movement over 24h, prolonged sedentary periods \>30 min without movement. Continuous recording 7 days prior to visit T0, T1, T2, T3, T4, T5

Sedentary

Guillaume Buiret

Guillaume Guillaume

APAORL2 study aims to evaluate the efficacy of a physical activity program on the sedentary and physical activity level during the 18-month program.

APAORL2 study is a randomized, open label, controlled, monocentric, intervention study that will be conducted among 96 patients treated for localized upper aerodigestive tract cancer.

Rationale:

A sedentary lifestyle has been clearly shown to reduce survival in cancer patients, mainly through metabolic changes. While the notions of sedentary lifestyle and physical inactivity overlap, they are not entirely synonymous.

The aim of this study is to examine the contribution of a physical activity program, during the treatment and post-treatment phases, in addition to the current care program, on behavior change (i.e. sedentary behaviors and Physical activity levels), quality of life and fatigue in patients with upper aerodigestive tract cancer

The primary objective is to show that the experimental group (combining the current care pathway + physical Activity program) has lower levels of sedentary behaviour and higher levels of physical activity than the control group (following the classic care pathway with Physical Activity awareness) after the treatment phase.

Patients will be randomly assigned to one of the 2 arms of the study according to a 1:1 ratio:

Group A: control group: standard care with recommendations on physical activity.

Group B: experimental group: Physical activity program

a randomized, open label, controlled, monocentric, study

Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer

Effect of Physical Activity Program on Sedentary and Physical Activity Level of Patients With Upper Aerodigestive Tract Cancer

cumulative time without movement over a day, as well as prolonged sedentary periods (\>30min without movement): continuous recording 7 days prior to hospital visits

Claude Bernard University

Centre Hospitalier de Valence

4 questionnaires to answer at baseline 45 minutes approx.

interview

questionnaires to answer at baseline 45 minutes

questionnaires

Veronique CHRISTOPHE, MDPhD

This study aims to determine the impact of sociocognitive and emotional factors on the time of the initial consult

identify wich sociocognitive factors influence the delay to go to a doctor after the emergence of first symptoms

Interventional Study Collecting Quantitative and Qualitative Data About Patient With Non Treated Cancer

Determinants of the Consultation Delay in Cancers of the Upper Aero Digestive Tract

median time between date of symptoms appearance and date of first consultation

medical data : medical history, symptoms, entry into care pathway sociodemographic and emotional indicators

Centre Oscar Lambret

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Integrated Molecular Profiling in Advanced Cancers Trial	NCT01505400	Breast Cancer Non-small Cell ... Colorectal Canc... Genitourinary C... Pancreatobiliar... Upper Aerodiges... Gynecological C... Melanoma Cancer... Rare Cancers Unknown Primary...		18 Years -	University Health Network, Toronto
Randomized Trial to Assess the Impact of a Screening Program on Upper Aerodigestive Tract Cancer Mortality in a High Risk Population	NCT00359645	Pharynx Cancer Larynx Cancer Oral Cavity Can... Oesophageal Can...	Screening by he...	40 Years -	Gustave Roussy, Cancer Campus, Grand Paris
Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer	NCT06184880	Upper Aerodiges... Head and Neck C...	behavioral Sedentary	18 Years -	Centre Hospitalier de Valence
Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer	NCT06184880	Upper Aerodiges... Head and Neck C...	behavioral Sedentary	18 Years -	Centre Hospitalier de Valence
Interventional Study Collecting Quantitative and Qualitative Data About Patient With Non Treated Cancer	NCT01647477	Upper Aerodiges...	interview questionnaires	18 Years -	Centre Oscar Lambret

Spots Global Cancer Trial Database for upper aerodigestive tract cancer