Présentation Générale - Call Center - Fondation Contre le Cancer 22 novembre 2018 - Brumammo.be
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Présentation Générale
Call Center - Fondation Contre le Cancer
22 novembre 2018
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Avantages et inconvénients du dépistage actuel
(1 MMG / 2 ans entre 50 et 69 ans)
AVANTAGES:
1. Réduit la lourdeur des traitements
2. Diminue la mortalité (20 %)
INCONVENIENTS:
1. Faux positifs (2 à 10 %)
2. Surdiagnostic (10 à 20 %)
3. Cancers d’intervalles (25 %)
4. Risque des RX (1 cancer pour 1.000 femmes dépistées pendant 30 ans)
HYPOTHESE
-> DIMINUER LA FREQUENCE DU DEPISTAGE CHEZ LES FEMMES AVEC UN
RISQUE FAIBLE
-> AUGMENTER LE DEPISTAGE CHEZ LES FEMMES AVEC UN
RISQUE ELEVE
POUR RENFORCER LES AVANTAGES ET REDUIRE LES INCONVENIENTS
Objectif et stratégie This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Une étude clinique randomisée
pour comparer
le dépistage standard actuel basé sur l’âge (“Mammotest”)
à un dépistage basé sur le niveau de risque individuel.
Incidence Stade II +
Risque
Age individuel *
* 1/ Age
6,5 ans: 2,5 + 4 2/ ATCD
3/ Densité
4/ Score polygénique
https://preventbreastcancer.org.uk/wp-content/uploads/2015/07/Genesis-Overview-2015.pdf
https://preventbreastcancer.org.uk/wp-content/uploads/2015/07/Genesis-Overview-2015.pdf
Le poids des facteurs de risque dans le score global
Personal/Familial
Biopsy History
4% 4%
Density
21% Age
42%
SNP's
29%Objectifs Primaire Diminue t’on l’incidence des stades II+ ( mortalité) ? Secondaires 1. Diminue t’on les inconvénients: faux négatifs (morbidité), surdiagnostics, cancers d’intervalle ? 2. Acceptabilité psychologique et sociale ? 3. Améliore t’on l’efficience économique ?
www.mypebs.eu
This project has received funding from the European Union’s Horizon 2020
25/01/2019 13
research and innovation programme under grant agreement N° 755394MyPeBS en bref
• 7 pays
• 85 000 femmes
• 2 groupes: UK 10 000 women
/ 3 centres
Standard/
Belgium 10 000
Risque individuel women / 3 regions
• 6.5 ans France 20 000
women / 30 areas
Israel 15 000
Italie 30 000
women / 9 centres
women / 6 regions
17/11/2018 Stakeholders & Investigators Meeting 14ON NE SAIT PAS ENCORE
QUELLE STRATEGIE
EST LA MEILLEURE !!!!
17/11/2018 Stakeholders & Investigators Meeting 15Structure du Projet This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
MyPeBS consortium partners
UNICANCER – trial sponsor and project coordinator
Gustave Roussy – stats & study PI University of Cambridge – study PI and genetics
Statlife – risk calculation (BCSC) Univ ersity of Manchester - investigation + psycho-socio + risk
CNGE - GPs association calculation (TC)
University Paris 13 – ethics and psycho-socio Loughborough University – radiology QC
University Lyon1 - psycho-socio Queen Mary University of London - Recommandations
ARC Foundation – communication & dissemniation ICPV (independant cancer patients’ voice)- patients advocacy
Santé Publique France – access to social security data
Associate partners:: CGFL, CNG, screening structures,
INCa, patients associations, gynecologists, radiologists etc
Azienda Unità Sanitaria Locale Reggio Emilia-(AUSL-RE) –
study PI + tomosynthesis
Azienda Ospedaliera Città della Salute e della Scienza di
Torino (CPO-AOU) - investigation + communication
Istituto Scientifico Romagnolo per lo Studio e la Cura dei
Assuta medical centers - study PI Tumori (IRST-IRCCS) - investigation
Institute for Study and Cancer Prevention (ISPO)- investigation
Im3D- imaging
Associate partners: 2 other regions (Este-monselice and lombardy)
ERASMUS University – medico-economics
Institut Jules Bordet – Study PI
European Cancer League, EONIX
Univ Californie San Francisco – WISDOM « sister » study Associate partners:: LUCK/CVKO, CCRef, Brumammo
17/11/2018 Stakeholders & Investigators Meeting 17MyPeBS organization
MyPeBS
WP4 - Economical Cost
Clinical trial effectiveness
evaluation
WP8 – Management of the project
WP1 – Sponsorship & results
USA WISDOM STUDY
CT data flow Exchange
WP5 - Sociological, Adherence, results, tools
ethical and psychological attendance and
WP2 - CT Investigation universalism
assessments
set up
WP3 - methodology WP6 - Communication Inclusion
and data analysis and dissemination Dissemination
Non inferiority then superiority
of personalised screening strategy
WP7 - Recommendations
17/11/2018 Stakeholders & Investigators Meeting 18MyPeBS’ governance bodies
General Assembly
Decision making body re. the Consortium
PROJECT
level
Executive Committee Scientific advisory
Project conduct (scientific and
administrative)
board
Project
Management
team
Day to day
operational conduct
Data monitoring
TRIAL Clinical Trial Steering Committee
and Ethics
Trial conduct
level Committee
17/11/2018 Stakeholders & Investigators Meeting 19Design de l’Etude – Protocole This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
1. La participation à l’étude est volontaire et gratuite 2. Il n’y a rien à payer pour les examens de dépistage 3. Toutes les données sont « dé-identifiées ». Les chercheurs ne connaissent pas votre identité, sauf le médecin que vous verrez 4. Vous pouvez gérer toutes vos données sur votre page privée de la plate- forme Web de l’étude 5. Il faut informer votre médecin traitant/gynécologue 6. Il faut rester attentive aux anomalies qui peuvent survenir dans vos seins 7. A la fin de l’étude, vous serez avertie des résultats 8. Vous êtes libre de quitter l’étude (il faut le signaler !)
Recrutement des femmes
40-70 ans
(pendant 2,5 ans)
Critères d’ Inclusion
Eligibilité
Critères d’Exclusion
Randomisation
Score de risque
Dépistage Standard
(1 x/2 ans chez 50-69)
Dépistage selon le niveau
de risque (4 sous-groupes)
11
Suivi pendant 4 ans
17/11/2018Recrutement des femmes
40-70 ans
(pendant 2,5 ans)
Critères d’ Inclusion
Eligibilité
Critères d’Exclusion
Randomisation
Score de risque
Dépistage Standard
(1 x/2 ans chez 50-69)
Dépistage selon le niveau
de risque (4 sous-groupes)
11
Suivi pendant 4 ans
17/11/2018CRITERES D’INCLUSION Pour participer IL FAUT: 1. Être une femme entre 40 à 70 ans (inclus) 2. Parler couramment le néerlandais, le français ou l’anglais 3. Avoir un numéro NISS et être en ordre de mutuelle 4. Disposer d’une adresse e-mail et d’un GSM 5. Etre d’accord de suivre la procédure du protocole 6. Signer le Consentement Informé
CRITERES D’EXCLUSION Ne peuvent PAS participer les femmes qui ont: 1. Un antécédent de CANCER DU SEIN (invasif ou « in situ ») 2. Un antécédent de biopsie avec ANAPLASIE ATYPIQUE 3. Un antécédent de RADIOTHÉRAPIE THORACIQUE (lymphomes) 4. Une mutation génétique à très haut risque (BRCA1/2, TP53 …) 5. Une mastectomie BILATÉRALE 6. Une mammographie anormale avec examens COMPLÉMENTAIRES TOUJOURS EN COURS
Recrutement des femmes
40-70 ans
(pendant 2,5 ans)
Critères d’ Inclusion
Eligibilité
Critères d’Exclusion
Randomisation
Score de risque
Dépistage Standard
(1 x/2 ans chez 50-69)
Dépistage selon le niveau
de risque (4 sous-groupes)
11
Suivi pendant 4 ans
17/11/2018DÉPISTAGE STANDARD
1. 40-49 ans : pas de MMG
pour les 45+: une MMG au début; pour les 40-49: une MMG à la fin
1. 50-69 ans : MMG tous les 2 ans (« Mammotest »)Recrutement des femmes
40-70 ans
(pendant 2,5 ans)
Critères d’ Inclusion
Eligibilité
Critères d’Exclusion
Randomisation
Score de risque
Dépistage Standard
(1 x/2 ans chez 50-69)
Dépistage selon le niveau
de risque (4 sous-groupes)
11
Suivi pendant 4 ans
17/11/2018DÉPISTAGE SELON LE NIVEAU DE RISQUE (tous âges)
1. BAS RISQUE : risque de cancer du sein dans les 5 ans = 1/110
-> pas de mammographie
2. RISQUE MOYEN : risque de cancer du sein dans les 5 ans = 1/60
-> mammographie tous les 2 ans (Echo si seins denses)
3. RISQUE ÉLEVÉ : risque de cancer du sein dans les 5 ans = 1/30
-> mammographie tous les ans (Echos si seins denses)
4. RISQUE TRÈS ÉLEVÉ: risque de cancer du sein dans les 5 ans = 1/16
-> examen d’imagerie tous les 6 mois (en alternance une
mammographie+Echo et une Résonance Magnétique)Screening strategy in the stratified
arm
Lauby-Secretan 2015, Kerlikowske 2015, Shousboe Ann Int Med 2011, Trentham- Dietz 2016, Evans 2016 2017
17/11/2018 Stakeholders & Investigators Meeting 18Le Rendez-Vous d’inclusion
(avec le médecin ou l’infirmière
de recherche)
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394VISITE 1 (60’)
1. Signature du Consentement Informé
2. Ouverture de votre espace privé sur la plate-forme « MyPeBS »
3. Répondre aux questionnaires:
• antécédents personnels et familiaux
• style de vie
• connaissance sur le dépistage, anxiété, compréhension
4. Randomisation
SI « Dépistage Standard »: STOP - prise de RV pour le prochain Mammotest.
Si « Dépistage en fonction du risque »:
5. prélèvement de salive pour l’analyse génétique
6. Prise de RV pour VISITE 2 (5 à 8 semaines)VISITE 2 (20’) 1. Annonce du niveau de risque 2. Calendrier pour le suivi des 4 prochaines années
LE CONSENTEMENT INFORMÉ
Consentement général sur le protocole de l’étude
+
Consentements facultatifs
1. J’accepte de laisser le reste de mon ADN pour d’autres études dans le
domaine de l’oncologie
2. J’accepte que mes données soient croisées avec celles du Registre
National du Cancer, du programme de dépistage, ou des mutuelles
3. J’accepte que le matériel génétique et les images soient utilsiées pour
des recherches ultérieures
4. J’accepte que mon médecin traitant soit informé de ma participationLe suivi This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
1. Faire les examens selon le programme établi 2. Introduire les dates et les résultats des examens dans la plate-forme Web 3. Répondre aux questionnaires (3 mois, 1 an, 2 ans) 4. Signaler les événements qui peuvent modifier le niveau de risque (symptômes et examens complémentaires, cancer du sein ou des ovaires dans la famille)
Risk result sheets This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Is there anything I Is there anything
can do to reduce else I need to
my risk? know?
Yes there are some things that you You need to remain aware of your MYyPEBS ID:
can do to minimize your risk of breast health: in case you feel Tube ID : n°123456789
breast cancer something abnormal in one of your
breasts, please refer to your
treating physician (abnormal lump,
change in shape, liquid flow...)
Maintain a healthy body Personal Breast
weight
Cancer Risk
Where can I get more
Eat a healthy diet with Evaluation and
plenty of fruits and
information on risk
reduction? Screening Program
vegetables
Institut National du cancer: [to be
adapted to each country]:
Limit the amount of http://www.e-cancer.fr/Comprendre-
alcohol you drink prevenir-depister/Reduire-les-risques-
de-cancer
Exercise regularly You may find additional information on
risk reduction measures on:
https://cancer-code-
europe.iarc.fr/index.php/fr/
17/11/2018 Stakeholders & Investigators Meeting 38What is my breast What personalised Questions?
cancer risk? screening If you want more detailed information on your
risk estimation
programme is Please ask your investigator who will be able to
provide more details
Compared to the average proposed for me? If you think your risk estimate may need
for your age, your breast reevaluation
Please enter new data that may change your risk
cancer risk is Average estimation (new cancer in your family, new data
on a breast biopsy, etc) into your personal
MyPeBS portal
Your risk level will be reestimated and a new
sheet sent to you if your risk category has
Average The proposed screening changed!
programme for you is as
Queries about the MyPeBS study or result
follows:
In this risk category, about You will find a FAQ on your MyPeBS personal
portal. For medical questions, please ask your
1 in 70 women may Mammogram Ultrasound MyPeBS investigator or personal physician.
develop breast cancer If you have been diagnosed with breast cancer
Oct 2019 - -
within the next 5 years. Please refer this diagnosis in your personal
MyPeBS portal. Being part of MyPeBS does not
change your care.
Oct 2020 x x
For more information on MyPeBS trial and
project
Oct 2021 - - www.mypebs.eu
Bases of your risk estimation :
This estimation was done using the
Oct 2022 x x
information you provided in your
questionnaires + your breast You will receive notices for these
mammographic density + your saliva test examinations 2 months before the
17/11/2018
result (Polygenic risk score (PRS)) scheduled
Stakeholders timing Meeting
& Investigators 39What is my breast What personalised Questions?
cancer risk? screening If you want more detailed information on your
risk estimation
programme is Please ask your investigator who will be able to
provide more details
Compared to the average proposed for me? If you think your risk estimate may need
for your age, your breast reevaluation
Please enter new data that may change your risk
cancer risk is High estimation (new family history, new data on a
breast biopsy, etc) into your personal MyPeBS
portal
Your risk level will be reestimated and a new
sheet sent to you if your risk category has
High The suggested screening changed!
programme for you is as
follows: Queries about the MyPeBS study or result
In this risk category, 1 in 20 You will find a FAQ on your MyPeBS personal
portal. For medical questions, please ask your
to 60 women may develop Mammogram Ultrasound MyPeBS investigator or personal physician.
breast cancer within the
Oct 2019 x x If you have been diagnosed with breast cancer
next 5 years. Please refer this diagnosis in your personal
MyPeBS portal. Being part of MyPeBS does not
Oct 2020 x x change your care. You can remain on study after
a diagnosis of breast cancer.
Oct 2021 x x For more information on MyPeBS trial and
project
www.mypebs.eu
Bases of your risk estimation : Oct 2022 x x
This estimation was done using the
information you provided in your
questionnaires + your breast You will receive notices for these
mammographic density + your saliva test examinations 2 months before the
17/11/2018
result (Polygenic risk score (PRS)) scheduled timing 40
Stakeholders & Investigators MeetingWhat is my breast What personalised Questions?
cancer risk? screening If you want more detailed information on your
risk estimation
programme is Please ask your investigator who will be able to
provide more details
Compared to the average proposed for me? If you think your risk estimate may need
for your age, your breast reevaluation
Please enter new data that may change your risk
cancer risk is very high estimation (new family history, new data on a
breast biopsy, etc) into your personal MyPeBS
portal
Your risk level will be reestimated and a new
sheet sent to you if your risk category has
Very High The suggested screening changed!
programme for you is as
follows: Queries about the MyPeBS study or result
In this risk category, more You will find a FAQ on your MyPeBS personal
portal. For medical questions, please ask your
than 1 in 17 women may Mammogram MRI MyPeBS investigator or personal physician.
develop breast cancer
Oct 2019 x x If you have been diagnosed with breast cancer
within the next 5 years. Please refer this diagnosis in your personal
MyPeBS portal. Being part of MyPeBS does not
Oct 2020 x x change your care. You can remain on study after
Genetic counselling is a diagnosis of breast cancer.
recommended. Oct 2021 x x For more information on MyPeBS trial and
project
www.mypebs.eu
Bases of your risk estimation : Oct 2022 x x
This estimation was done using the
information you provided in your You will receive notices for these
questionnaires + your breast examinations 2 months before the
mammographic
17/11/2018density + your saliva test scheduled
Stakeholders timing Meeting
& Investigators 41
result (Polygenic risk score (PRS))What is my breast What personalised Questions?
cancer risk? screening If you want more detailed information on your
risk estimation
programme is Please ask your investigator who will be able to
provide more details
Compared to the average proposed for me? If you think your risk estimate may need
for your age, your breast reevaluation
Please enter new data that may change your risk
cancer risk is Low estimation (new family history, new data on a
breast biopsy, etc) into your personal MyPeBS
portal
Your risk level will be reestimated and a new
sheet sent to you if your risk category has
Low The suggested screening changed!
programme for you is as
follows: Queries about the MyPeBS study or result
In this risk category, less You will find a FAQ on your MyPeBS personal
portal. For medical questions, please ask your
than 1 in 100 women may Mammogram Ultrasound MyPeBS investigator or personal physician.
develop breast cancer
Oct 2019 - - If you have been diagnosed with breast cancer
within the next 5 years. Please refer this diagnosis in your personal
MyPeBS portal. Being part of MyPeBS does not
Oct 2020 - - change your care. You can remain on study after
a diagnosis of breast cancer.
Oct 2021 - - For more information on MyPeBS trial and
project
www.mypebs.eu
Bases of your risk estimation : Oct 2022 x x
This estimation was done using the
information you provided in your
questionnaires + your breast You will receive notices for this
mammographic density + your saliva test examination 2 months before the
17/11/2018
result (Polygenic risk score (PRS)) scheduled
Stakeholders timing Meeting
& Investigators 42Website
www.mypebs.eu
+ e-learning module
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394In Belgium This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
45
Folded leaflet
49Poster/billboard
50Q&As
51Thank you for your attention! This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
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