interventions of Cancéropôle Nord-Ouest during 1 year after an observational period of 2 years.

interventions of Cancéropôle Nord-Ouest during 2 years after an observational period of 1 year.

During the time defined by the randomization, the Cancéropôle Nord-Ouest offers to help to develop a clinical research activities in the centers. The various aids are : Structuring clinical research at the local level, Support (strategy, logistics, technical, Data management, methodology), a portfolio of "straightforward" studies ( French National Cancer Institute, cooperative groups conducting cancer clinical research, New Project), Good Clinical Practice training, Clinical research technician, Others,.....

interventions of the Cancéropôle Nord-Ouest

Jean-Claude BARBARE, MD

This study evaluates the interventions of the Cancéropôle Nord-Ouest in the development of clinical research in non-academic health institution. The randomization, in open label,determines the duration of the interventions. Half of participants will receive the interventions during 2 years, while the other half during 1 year.

French National recommendations ask to increase the accessibility of patients to clinical trials. But this accessibility is far from the optimal care in non-university healthcare institutions (public and private hospital). These non-academic healthcare facilities support at national level about 60% of chemotherapy and 70% of radiotherapy, but only 17% of the inclusions in trials.

A dissociation exist between a care package guaranteed on quality criteria (criteria to obtain the capacity to treat the cancers in healthcare institution) distributed all over the country, and the research, mainly concentrated in few referral centers (University hospital and French Comprehensive Cancer Centers).

Clinical trials allow patients to have early access to new treatments, optimal and formalized information, and supported by physicians in connection with a strict protocol for patients included.

Several studies have shown the existence of geographical and socio-economic determinants for access to reference centers and for the duration of survival of cancer patients. In France, it was found that for patients with gastrointestinal cancer, the remoteness of the place of residence compared to the nearest referral center and a higher level of deprivation decreased the probability of being supported in a reference center.

The hypothesis of the ERNU study is that aid from the Cancéropole Nord-Ouest facilitates clinical research activity resulting in a significant development of inclusions in non-university centers of the french north-west inter-region with an influence on the social and geographical inequalities recruitment.

Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU)

Randomized Trial Evaluating Intervention of the Cancéropôle Nord-Ouest in the Development of Clinical Research in Non-Academic Health Institutions (ERNU)

Measure the increase in inclusions in clinical trials of patients attending a Hospital or a private clinic "authorized to treat cancer" associated with a support provided by the Cancéropôle Nord-Ouest

assessment of the average of the reduction of social inequalities recruitment in clinical trial before and after the intervention of the Cancéropöle Nord-Ouest in each centers and in global. the social inequalities are calculated with the social and demographic tool developped by the french national institute of statistic and economic studies

Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France

Institut National de la Santé et de la Recherche Médical (INSERM) 1086 (Pr Guy LAUNOY) Centre F. BACLESSE, Caen, France

Centre Hospitalier Universitaire, Amiens

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fulvestrant

Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007

Alain FLINOIS

the purpose of this study is to describe the way Faslodex is used in France, in patients suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to determine patients profile

Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France

AstraZeneca

Francisco Sapunar - Medical Science Director

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Invitation letter to the screening program with the FIT test

Prior notification to the new entrants, followed by an invitation letter to the screening program with the FIT test

Invitation letter to visit its own GP who will deliver the FIT test

The individuals eligible for the colorectal cancer screening program will receive at home an invitation letter to participate to the program along with a FIT test. The follow-up will be similar to the standard of care, i.e. reminder letters at 5 and 10 months if there is no participation, and reminders if no coloscopy after a positive FIT test

Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program

Dispatch of a notification, one month prior the dispatch of the screening test along the invitation letter. This intervention is among the new entrants to the national program

Sending of a prior notification to the new entrants of the national program

Maurice TANGUY, MD

Myriam GUERBAZ SOMMI, MD

Jean BOTO KEKY, MD

This is a randomized controlled trial comparing the effect on participation rates to colorectal cancer screening between an intervention arm (invitation letter to the screening program including a FIT test with or without prior notification) and a control arm with the standard of care (invitation letter to visit the GP who will deliver the FIT test).

The participation to the national screening program for colorectal cancer in France is low. In order to improve the performances of its organized program, the National Cancer Institute is planning to modify the invitation procedure. This is a pilot project and if an improvement in the program performances is reported, the invitation procedure may be scaled up.

Eligible individuals for colorectal cancer screening will be identified by the Regional Cancer Screening Coordinating Centre and randomized into the intervention or control arms. They will be followed for FIT test submission to the central laboratory (participation to screening). Those who did not send their test will receive reminder letters. Those who had a positive FIT test will be followed up for coloscopy referral, and result of the coloscopy. Comparison of the participation rates to screening program and to coloscopy among those with a positive FIT test will be compared between the two study arms.

This is a three-arm study with a parallel study design

Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program

Evaluation of the Home Delivery of the Screening Kit, and Impact of a Prior Notification Among New Participants to the National Organized Colorectal Cancer Screening Program (Among New Participants Only)

Comparison of the participation rate to the screening program between the intervention and the control arms

Comparison of the referral rates to coloscopy between the intervention and the control arms

Comparison of the participation rates to the screening program between the individuals aged 50-52 of the Intervention1 and the Intervention sub-study arms

International Agency for Research on Cancer

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

Women born between 1972 and 1982 who were not exposed to HPV vaccination

Women born between 1983 and 1993 who were potentially exposed to HPV vaccination

biological sample analysis

Jean-Luc PRETET, Pr

The objective is to estimate the prevalence of the different genotypes of human papillomaviruses (HPV) in histologically proven high-grade lesions of the cervix in patients born between 1972 and 1993. It is plan to determine if the prevalence of HPV16 and HPV18 is lower in the population born between 1983 and 1993 and potentially exposed to HPV vaccination compared to those born between 1972 and 1982 who were not exposed to vaccination. Thus the investigators should be able to determine whether the introduction of HPV vaccination in France in 2007 has had an impact on the development of high-grade lesions associated with HPV16 and HPV18.

The prevalence of the different HPV in high-grade lesions (CIN2/3) will be determined using the INNOLiPA HPV extra v2 genotyping kit (Fujirebio). Only samples with a histologically proven high-grade cervical lesion (grade 2 or 3 intraepithelial neoplasia) are concerned. The patient year of birth, the year of the lesion diagnosis and the histological diagnosis will be recorded Participating laboratories will select eligible cervical samples (biopsies or surgical specimen) according to the inclusion criteria defined in the protocol. Only cervical samples with sufficient biological material will be selected. The selected tissue blocks will be sent to the Papillomavirus National Reference Center (NRC) by mail (pre-paid envelope provided) in accordance with the rules for the transport of biological samples. After receipt by the NRC, the tissue blocks will be anonymized. After HPV genotyping, the blocks will be returned to the laboratory. Transport costs are covered by the Papillomavirus NRC.

Samples have to be fixed in 4% buffered formaldehyde (maximum 24 hours) and then included in paraffin for histopathological evaluation. On each of the selected histological pieces, the papillomavirus NRC will make 5μm thick sections using a microtome. The number of sections to be made depends on the size of the histological specimen. A minimum surface area equivalent to 5 sections of 5μm of a 125 mm2 piece is required for genotyping.

Tissue sections are grouped in a labelled 2 mL screw tube. To avoid any contamination between samples, the microtome blade will be carefully cleaned with xylene and then 95% ethanol between each block.

After DNA extraction using the QiaAmp DNA mini Kit (Qiagen), HPV genotype analysis will be performed using molecular techniques for the detection of human papillomavirus DNA. The investigators will use the INNO-LiPA HPV Genotyping Extra II (Fujirebio) kit. This is a Polymerase Chain Reaction (PCR) technique using degenerate primers followed by reverse hybridization on strips on which the specific probes of 32 alpha HPV genotypes are immobilized. This kit allows the detection of 13 high-risk HPV genotypes (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 52, 56, 58, 59, 68), 6 HPVs that are likely to be at risk (HPV 26, 53, 66, 70, 73, 82) and 14 low-risk or unclassified HPVs (HPV6, 11, 40, 42, 43, 44, 54, 61, 62, 67, 81, 83, 89). In addition, the samples will be analyzed by PCR luminex according to the technique published by Schmitt et al, J Clin Microbiol 2010. In addition to alpha HPV, this technique allows the detection of sixty beta and gamma HPVs.

Characteristics of the subjects to be included A description of patients included in the study (women born between 1972 and 1982, on the one hand, and women born between 1983 and 1993, on the other) will include age at time of sampling, year of sampling, stage of lesion CIN2 or 3, and histological type.

Comparisons between age groups will be made using Student tests for quantitative variables and Chi-square tests for qualitative variables, while respecting the conditions for applying these tests.

Main judgment criteria Prevalences of high-risk HPV 16 or 18 genotypes will be described in both age groups with their 95% confidence intervals. These prevalences will be compared between the two age groups using the Chi-square test.

Secondary Judgment Criterion Prevalences of high-risk HPV genotypes other than 16 or 18 will be described in both age groups with their 95% confidence intervals. These prevalences will be compared between the two age groups using the Chi-square test.

Additional analyses The distribution of the different HPV genotypes will be described for both age groups.

The number of samples required for the study is 606: 303 samples from women born between 1972 and 1982 and 303 samples from women born between 1983 and 1993.

The calculation of the number of samples required is based on the following assumptions: the prevalence of HPV16 and/or HPV18 in high-grade lesions of women is estimated at 62%. The minimum decrease after the introduction of HPV vaccination, interesting from a population health point of view, that the investigators wish to highlight is 10%, i.e. an expected prevalence among women born between 1983 and 1993 of 52%.

For a power set at 80% and an alpha risk at 5%, a unilateral formulation of hypotheses (only a decrease in prevalence is possible) and an equal number of samples from women aged 25-34 and 35-44, the number of samples required per group is 303.

Impact of HPV Vaccination on Cervical High Grade Lesions in France

Impact of HPV Vaccination on the Distribution of HPV in High Grade Lesions of the Cervix in France

Prevalence of HPV16 and HPV18 genotypes in high grade cervical lesions of the cervix in women born between 1972 and 1993

Prevalence of high risk HPV other than HPV16 and HPV18 genotypes and prevalence of low risk HPV in high grade cervical lesions of the cervix in women born between 1972 and 1993

Centre Hospitalier Universitaire de Besancon

Blood and Lymph Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Chronic Graft Versus Host Disease

Myeloid Leukemia

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Amino Acids

Asciminib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Adult patients with Ph+ CML-CP previously treated with two or more tyrosine kinase inhibitors

There is no treatment allocation. Patients administered Asciminib by prescription will be enrolled

Novartis Pharmaceuticals

The purpose of this study is to enhance the knowledge on asciminib treatment in a broader and real-life population by collecting additional data to characterize the treatment patterns of patients treated with asciminib, with a primary objective represented by maintenance on treatment at 12 months.

The ASSURE-3 study is a national, multicentric, non-interventional, prospective study in real-life conditions with primary data collection in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more Tyrosine Kinase Inhibitors (TKIs). It will be conducted in France with hematologists, onco-hematologists, physicians with documented involvement in managing Ph+ CML-CP patients in routine practice, practicing in public or private health care institutions. Each patient will be followed during 15 months at M0, M1 and then every 3 months (rhythm of visits according to the routine clinical care), or until premature discontinuation of asciminib treatment.

Historical data will be abstracted retrospectively by the participating physicians from patient files, to collect information using an electronic case report form (eCRF). Primary data will be collected during inclusion and follow-up visits

Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France

Scemblix® (Asciminib): Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML-CP in Real World Setting in France

Proportion of patients remaining on asciminib treatment at 12 months to be provided

Molecular response to treatment: Response to treatment (MMR, BCR::ABL1 ≤ 0.1% on the International Scale, IS) at 12 months (+/- 1 month) for patients not in MMR at treatment initiation

Molecular response to treatment: Maintenance of molecular response (MMR, BCR::ABL1 ≤ 0.1% on the International Scale, IS) at 12 months (+/- 1 month) for patients in MMR at treatment initiation

Molecular response to treatment: Kinetics of response: MR2, MMR, MR4.0, MR4.5, undetectable MR4.5 for all patients.

MR2, MR4, MR4.5 are defined as the transcript ratio of BCR-ABL1/ABL1 being 1% or less, 0.01% or less and 0.0032% or less respectively

Kinetics of response: BCR::ABL1 on the International Scale (IS) for all patients

Kinetics of response: Time to MMR for patients not in MMR at treatment initiation

Molecular response to treatment: Duration of MMR for patients not in MMR at treatment initiation

EFS: time from index date to occurrence of one the events listed among variables:

* lack of efficacy, i.e., BRC::ABL1\>1% or loss of CCyR if assessed
* disease progression (CML-AP/BP, CML death)
* death from any cause
* definitive treatment discontinuation due to any reason

PFS: time from index date to occurrence of one of the progression markers listed among variables:

* disease progression (CML-AP/BP, CML death),
* death from any cause,
* definitive treatment discontinuation due to any reason

Charlson comorbidity index (CCI) at index date

The EORTC QLQ-C30 contains 30 questions assessed by the participant. There are 9 multiple-item scales: 5 scales that assess aspects of functioning (physical, role functioning, cognitive, emotional, and social); 3 symptom scales (Fatigue, Pain, and Nausea and Vomiting); and a global health status/Quality of Life (QOL) scale. There are 5 single-item measures assessing additional symptoms (i.e., dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and a single item concerning perceived financial impact of the disease. All but two questions have 4-point scales ranging from "Not at all" to "Very much." The two questions concerning global health status/ QOL have 7 point scales with ratings ranging from "Very poor" to "Excellent." For each of the 14 domains, final scores are transformed such that they range from 0-100, where higher scores indicate improvement.

The EORTC QLQ-CML24 was designed to supplement the QLQ-C30 - the QLQ-CML24 is not a stand-alone instrument but is to be used in conjunction with the QLQ-C30.

The EORTC QLQ-CML 24 is composed of four multi-item scales and two single-item scales. The module consists of 24 items assessing symptoms burden (13 items), impact on worry/mood (4 items), impact on daily life (3 items), satisfaction with care and information (2 items) body image problems (1 item) and satisfaction with social life (1 item). The items were measured on four levels: 1=not at all, 2=a little, 3=quite a bit, 4=very much. For each domain, scores were averaged and transformed to 0 to 100. A higher score in satisfaction with social life domain indicates a higher level of satisfaction. A positive change from baseline indicates increasing satisfaction.

If available at end of treatment: mutational analysis, methods and results

Cross intolerance with previous TKI treatments

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU)	NCT02765451	Clinical Resear... Cancer	interventions o...	-	Centre Hospitalier Universitaire, Amiens
Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France	NCT00681369	Breast Cancer		-	AstraZeneca
Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France	NCT00681369	Breast Cancer		-	AstraZeneca
Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program	NCT05589675	Colorectal Canc...	Dispatch of the... Sending of a pr...	50 Years - 74 Years	International Agency for Research on Cancer
Impact of HPV Vaccination on Cervical High Grade Lesions in France	NCT04167501	Human Papilloma...	biological samp...	27 Years - 46 Years	Centre Hospitalier Universitaire de Besancon
Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France	NCT00681369	Breast Cancer		-	AstraZeneca
Impact of HPV Vaccination on Cervical High Grade Lesions in France	NCT04167501	Human Papilloma...	biological samp...	27 Years - 46 Years	Centre Hospitalier Universitaire de Besancon
Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France	NCT06092879	Chronic Myeloid...	Asciminib	18 Years - 99 Years	Novartis

Spots Global Cancer Trial Database for france

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Spots Global Cancer Trial Database for france

Every month we try and update this database with for france cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for france cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.