Mathilde Touvier, Dr

Pilar Galan, Dr

Serge Hercberg, Pr

Emmanuelle Kesse-Guyot, Dr

Sandrine Péneau, Dr

Léopold Fezeu, Dr

Chantal Julia, Dr

Valentina Andreeva, Dr

Allès Benjamin, Dr

Baudry Julia, Dr

Deschasaux Mélanie, Dr

The NutriNet-Santé study was set up to investigate nutrition and health relationships. Specifically, it was the first web-based cohort worldwide on such a large scale (n=171 000 as of 2021) focused on the complex link between nutrition and health status. It is characterized by a very detailed assessment of nutritional exposure and dietary behavior.

https://etude-nutrinet-sante.fr/ https://info.etude-nutrinet-sante.fr/en

NutriNet-Santé is a large-scale (n=171,000) web-based cohort coordinated by EREN, launched in France in 2009 to investigate nutrition and health relationships. All required ethics authorisations have been obtained (listed here). NutriNet-Santé participants regularly fill questionnaires through a dedicated and secure website, providing extensive, high-quality nutritional and non-nutritional data, including repeated data on socio-demographics and lifestyle (yearly), anthropometrics (every 6 months), dietary intake (every 6 months), physical activity (IPAQ questionnaire, yearly)5 and health status (every 6 months). NutriNet-Santé is characterised by a very detailed and up-to-date assessment of nutritional exposure and dietary behaviours. Usual dietary intakes are assessed at baseline and every 6 months thereafter through a series of 3 non-consecutive randomly assigned 24h dietary records. Daily energy, alcohol, micro- and macronutrient intakes are calculated using the published NutriNet-Santé food composition database (\>3,500 generic items). All major health events (e.g., cancers, cardio- and cerebrovascular diseases) are reported by the participants and validated by an expert committee of physicians based on medical records, and/or retrieved from the French National Health Insurance medico-administrative databases to limit potential reporting bias. In turn, mortality data are obtained from the exhaustive French National Mortality Registry (CépiDC). The number of incident events already registered is as follows: 4,200 cancers and 1,240 deaths. A sub-sample of the cohort (n=20,000) provided blood and urine samples, currently stored at -80°C in EREN's biobank.

Samples of serum, plasma, and buffy-coats (for genetic analyses), as well as urine samples was set up for 19 600 subjects of the cohort.

The NutriNet-Santé Study

The NutriNet-Santé Study. A Web-based Prospective Cohort Study of the Relationship Between Nutrition and Health and of Dietary Patterns and Nutritional Status Predictors

self reported though validated scales and/or questionnaires

combination of previsously listed mental and physical health outcomes

Institut National de la Santé Et de la Recherche Médicale, France

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Conservatoire national des Arts et Métiers

University of Paris 13

Symptoms and General Pathology

All Conditions

Infections

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Syndrome

Lymphoma

Lymphoma, Non-Hodgkin

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Sarcoma

Lymphoproliferative Disorders

Sarcoma, Kaposi

Lymphoma, AIDS-Related

Neoplasms by Histologic Type

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Connective and Soft Tissue

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

Virus Diseases

RNA Virus Infections

Genital Diseases

Urogenital Diseases

Slow Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Neoplasms, Vascular Tissue

Lymphoma, B-Cell

Lymphosarcoma

Soft Tissue Sarcoma

Kaposi Sarcoma

B-cell Lymphoma

All Drugs and Chemicals

Antibodies

Immunoglobulins

David A. Wohl

Ann C. Collier

William G. Powderly

Charles S. Rabkin

The purpose of this study is to find out why cancers develop in HIV-positive patients.

Cancer is a leading cause of death in AIDS patients. Common cancers in HIV-infected patients include Kaposi's sarcoma (KS) and non-Hodgkin's lymphoma (NHL), a cancer of the immune system. Risk factors include certain chemicals, viruses, and perhaps even anti-HIV drugs. Doctors would like to find out which risk factors are most important and how they relate to cancer in AIDS patients.

AIDS-associated malignancy represents a model system for investigations of carcinogenesis. There are few human conditions in which cancer rates are of the magnitude they are in HIV infection. While studies have investigated pre-cancer markers in HIV-infected patients, they have not correlated these markers with tumor samples. This study contributes to understanding oncogenesis of HIV-associated malignancies by establishing a collection of tumors linked with pre-cancer sera and lymphocyte specimens, as well as prospective questionnaire data.

At study entry, patients receive a comprehensive physical exam. Clinic staff interview the patient to collect data regarding medication history (particularly antiretroviral exposure), diet, occupational history, substance abuse, and sexual practices. This information is used to identify behavioral and environmental factors contributing to oncogenesis. In addition, baseline blood samples are analyzed for HHV-8 and EBV levels, anti-EBV and anti-HHV-8 antibodies, CD23, Th2 cytokines, tumor growth factors, chromosomal translocations associated with NHL, and other potential predictors of malignancy. At Month 6 and annually thereafter, patient records are abstracted for data on vital status, AIDS-defining illnesses, medications, and most recent CD4+ T cell and HIV RNA levels. At Years 1, 2, and 3, patients undergo physical exams and blood tests for malignancy surveillance. Any malignancies are biopsied and analyzed for oncogene identification and virology. The medical records of patients who die on study are reviewed to determine the cause of death and to rule out unreported cancer. No treatment is provided by this study.

A Study of Patients With AIDS Syndrome

Oncogenic Viral Pathogenesis and Cancer Risk Factors Among Patients With the Acquired Immunodeficiency Syndrome: A Prospective Cohort Study

National Cancer Institute (NCI)

National Institute of Allergy and Infectious Diseases (NIAID)

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Urologic Neoplasms

Urogenital Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Renal Cell Carcinoma

Data source and study cohort:

We conducted a retrospective cohort study using the Premier Healthcare Database (PHD, Premier Inc., Charlotte, NC), an extensive, US hospital-based, all-payer database representing approximately 20% of annual United States inpatient discharges at community and academic centers. The International Classification of Diseases, ninth revision (ICD-9), and tenth revision (ICD-10) procedure codes were used to identify patients who had undergone elective kidney cancer surgery between the 15 years of study from 2003 to 2017. The cohort was then restricted based on appropriate ICD-9 and ICD-10 diagnosis codes to ensure that surgery was performed for a kidney mass. The study cohort was also limited to adult patients (age \>= 18 years), "elective" cases based on administrative codes, as well as surgery on hospital day zero or one to minimize outlier patients who could skew the surgical outcomes.

Outcomes:

The primary outcome of this study was the 90-day complication rate. Complication rates were based on the Clavien-Dindo classification of surgical complications and divided into four categories: no complications, minor complications (Clavien grades 1, 2), and non-fatal major complications (Clavien grades 3, 4), and mortality (Clavien grade 5). Clinical systems also categorized complications (bleeding, cardiac, endocrine, gastrointestinal, infection, neurology, pulmonary, renal, soft tissue, urologic, venous thromboembolism) using Health Care Cost and Utilization Project Clinical Classification Software Level II or III designations; of note, the category for "surgical" complications was excluded given that all complications captured in this analysis are considered surgical complications. Secondary outcomes included patient disposition, length of hospital stay, and readmission rate.

The Association of Marital Status With Kidney Cancer Surgery Morbidity

Complication rates were based on the Clavien-Dindo classification of surgical complications and divided into four categories: no complications, minor complications (Clavien grades 1, 2), and non-fatal major complications (Clavien grades 3, 4), and mortality (Clavien grade 5).

patient disposition was divided into home and none home such as skilled nursing or rehabilitation facility

readmission was defined as readmitted into the hospital for any reason

Brigham and Women's Hospital

Beijing Tsinghua Chang Gung Hospital

Clinical Attending

Antineoplastic Agents

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Docetaxel

Hormones

Prednisone

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Tubulin Modulators

Antimitotic Agents

The dosage is adjusted according to the adverse reaction (according to the instructions).Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator;The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles. It is up to the researcher to decide whether to use prednisone or prednisolone.

Patients were treated with apantamide and ADT after enrollment. The patient received each drug treatment according to the instructions. The dosage is adjusted according to the adverse reaction (according to the instructions)Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT used in each research center are determined by the investigator.

Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally; ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator; The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles.

apantamide+docetaxel+ADT

apantamide+ADT treatment

Benkang Shi, Dr.

Benkang Shi

This is a multicenter, prospective, cohort study to evaluate the efficacy and safety of apantamide+docetaxel+ADT versus apantamide+ADT in the treatment of patients with high tumor mHSPC.220 patients with high tumor mHSPC will be included and divided into two treatment groups according to the treatment plan:Treatment group 1: apantamide+docetaxel+ADT,Treatment group 2: apantamide+ADT treatment.The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.

This is a multicenter, prospective, cohort study to evaluate the efficacy and safety of apantamide+docetaxel+ADT versus apantamide+ADT in the treatment of patients with high tumor mHSPC.220 patients with high tumor mHSPC will be included and divided into two treatment groups according to the treatment plan:

Treatment group 1: apantamide+docetaxel+ADT

Patients were treated with apantamide+docetaxel+ADT after enrollment. The patient received each drug treatment according to the instructions. The dosage is adjusted according to the adverse reaction (according to the instructions).Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator;The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles. It is up to the researcher to decide whether to use prednisone or prednisolone. To prevent docetaxel related hypersensitivity and fluid retention, oral administration of 8 mg dexamethasone is recommended 12 hours, 3 hours and 1 hour before infusion of docetaxel.The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.

Treatment group 2: apantamide+ADT treatment

Patients were treated with apantamide and ADT after enrollment. The patient received each drug treatment according to the instructions. The dosage is adjusted according to the adverse reaction (according to the instructions)Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT used in each research center are determined by the investigator.The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.

Experimental: apantamide+docetaxel+ADT;Active.Comparator: apantamide+ADT treatment

Efficacy and Safety of Apantamide Combined With Docetaxel and ADT vs. Apantamide Combined With ADT in Patients With High Tumor Burden mHSPC: a Multicenter and Prospective Cohort Study

RPFS is defined as the time from the start of study treatment to the occurrence of imaging progress or death due to any reason, whichever occurs first.（%）

Asymptomatic skeletal event (SSE) survival.（%）

Qilu Hospital of Shandong University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The NutriNet-Santé Study	NCT03335644	Diet, Food, and... Exercise Diseases Catego... Cohort Studies Adult Anthropometry Humans Internet Surveys and Que... Mortality		15 Years -	University of Paris 13
A Study of Patients With AIDS Syndrome	NCT00001120	Sarcoma, Kaposi Lymphoma, Non-H... HIV Infections Lymphoma, AIDS-...		18 Years -	National Institute of Allergy and Infectious Diseases (NIAID)
The NutriNet-Santé Study	NCT03335644	Diet, Food, and... Exercise Diseases Catego... Cohort Studies Adult Anthropometry Humans Internet Surveys and Que... Mortality		15 Years -	University of Paris 13
The Association of Marital Status With Kidney Cancer Surgery Morbidity	NCT05526599	Marriage Kidney Neoplasm... Surgery-Complic... Cohort Studies		18 Years -	Beijing Tsinghua Chang Gung Hospital
Efficacy and Safety of Apantamide Combined With Docetaxel and ADT vs. Apantamide Combined With ADT in Patients With High Tumor Burden mHSPC: a Multicenter and Prospective Cohort Study	NCT05713578	Cohort Studies	apantamide+doce... apantamide+ADT ...	18 Years - 90 Years	Qilu Hospital of Shandong University

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