présentation générale - brumammo · présentation générale call center - fondation contre le...
TRANSCRIPT
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Présentation Générale
Call Center - Fondation Contre le Cancer 22 novembre 2018
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
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Objectif et stratégie
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.
* 1/ Age 2/ ATCD 3/ Densité 4/ Score polygénique
Age Risque
individuel *
6,5 ans: 2,5 + 4
Incidence Stade II +
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
Age 42%
SNP's 29%
Density 21%
Biopsy 4%
Personal/Familial History
4%
Le poids des facteurs de risque dans le score global
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 ?
25/01/2019 13 This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
www.mypebs.eu
MyPeBS en bref
17/11/2018 Stakeholders & Investigators Meeting 14
• 7 pays
• 85 000 femmes
• 2 groupes:
Standard/
Risque individuel
• 6.5 ans
UK 10 000 women / 3 centres
Italie 30 000 women / 6 regions
Belgium 10 000 women / 3 regions
Israel 15 000 women / 9 centres
France 20 000 women / 30 areas
ON NE SAIT PAS ENCORE
QUELLE STRATEGIE
EST LA MEILLEURE !!!!
17/11/2018 Stakeholders & Investigators Meeting 15
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Structure du Projet
MyPeBS consortium partners
17/11/2018 Stakeholders & Investigators Meeting 17
University of Cambridge – study PI and genetics
Univ ersity of Manchester - investigation + psycho-socio + risk
calculation (TC)
Loughborough University – radiology QC
Queen Mary University of London - Recommandations
ICPV (independant cancer patients’ voice)- patients advocacy
Assuta medical centers - study PI
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 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
Univ Californie San Francisco – WISDOM « sister » study
Institut Jules Bordet – Study PI
European Cancer League, EONIX
Associate partners:: LUCK/CVKO, CCRef, Brumammo
UNICANCER – trial sponsor and project coordinator
Gustave Roussy – stats & study PI
Statlife – risk calculation (BCSC)
CNGE - GPs association
University Paris 13 – ethics and psycho-socio
University Lyon1 - psycho-socio
ARC Foundation – communication & dissemniation
Santé Publique France – access to social security data
Associate partners:: CGFL, CNG, screening structures,
INCa, patients associations, gynecologists, radiologists etc
MyPeBS organization U
SA W
ISDO
M STU
DY
Exchange results, tools
Clinical trial
WP1 – Sponsorship & CT data flow
WP2 - CT Investigation
WP3 - methodology and data analysis
Non inferiority then superiority of personalised screening strategy
set up
results
WP4 - Economical evaluation
Cost effectiveness
WP5 - Sociological, ethical and psychological
assessments
Adherence, attendance and
universalism
WP6 - Communication and dissemination
Inclusion Dissemination
WP7 - Recommendations
WP
8 –
Man
agem
ent
of
the
pro
ject
MyPeBS
17/11/2018 Stakeholders & Investigators Meeting 18
17/11/2018 Stakeholders & Investigators Meeting 19
MyPeBS’ governance bodies
General Assembly Decision making body re. the Consortium
Executive Committee Project conduct (scientific and
administrative)
Scientific advisory board
Data monitoring and Ethics Committee
Clinical Trial Steering Committee Trial conduct
PROJECT level
Project Management
team Day to day
operational conduct
TRIAL level
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Design de l’Etude – Protocole
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)
Eligibilité
Randomisation
Dépistage Standard (1 x/2 ans chez 50-69)
Score de risque
Dépistage selon le niveau de risque (4 sous-groupes)
Suivi pendant 4 ans
Critères d’ Inclusion Critères d’Exclusion
11
17/11/2018
Recrutement des femmes 40-70 ans
(pendant 2,5 ans)
Eligibilité
Randomisation
Dépistage Standard (1 x/2 ans chez 50-69)
Score de risque
Dépistage selon le niveau de risque (4 sous-groupes)
Suivi pendant 4 ans
Critères d’ Inclusion Critères d’Exclusion
11
17/11/2018
CRITERES 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)
Eligibilité
Randomisation
Dépistage Standard (1 x/2 ans chez 50-69)
Score de risque
Dépistage selon le niveau de risque (4 sous-groupes)
Suivi pendant 4 ans
Critères d’ Inclusion Critères d’Exclusion
11
17/11/2018
DÉPISTAGE 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)
Eligibilité
Randomisation
Dépistage Standard (1 x/2 ans chez 50-69)
Score de risque
Dépistage selon le niveau de risque (4 sous-groupes)
Suivi pendant 4 ans
Critères d’ Inclusion Critères d’Exclusion
11
17/11/2018
DÉPISTAGE 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
18 17/11/2018 Stakeholders & Investigators Meeting
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Le Rendez-Vous d’inclusion (avec le médecin ou l’infirmière
de recherche)
VISITE 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 participation
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Le suivi
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)
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Risk result sheets
MYyPEBS ID: Tube ID : n°123456789
Personal Breast Cancer Risk Evaluation and Screening Program
Is there anything I can do to reduce
my risk?
Yes there are some things that you can do to minimize your risk of breast cancer
Maintain a healthy body weight Eat a healthy diet with plenty of fruits and vegetables Limit the amount of alcohol you drink Exercise regularly
Where can I get more information on risk reduction?
Institut National du cancer: [to be adapted to each country]: http://www.e-cancer.fr/Comprendre-prevenir-depister/Reduire-les-risques-de-cancer You may find additional information on risk reduction measures on: https://cancer-code-europe.iarc.fr/index.php/fr/
Is there anything else I need to
know?
You need to remain aware of your breast health: in case you feel something abnormal in one of your breasts, please refer to your treating physician (abnormal lump, change in shape, liquid flow...)
17/11/2018 Stakeholders & Investigators Meeting 38
What is my breast cancer risk?
Compared to the average for your age, your breast cancer risk is Average
Average
In this risk category, about 1 in 70 women may
develop breast cancer within the next 5 years.
What personalised screening
programme is proposed for me?
The proposed screening programme for you is as follows:
Questions? If you want more detailed information on your risk estimation Please ask your investigator who will be able to provide more details If you think your risk estimate may need reevaluation Please enter new data that may change your risk 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 changed! Queries about the MyPeBS study or result You will find a FAQ on your MyPeBS personal portal. For medical questions, please ask your MyPeBS investigator or personal physician. If you have been diagnosed with breast cancer Please refer this diagnosis in your personal MyPeBS portal. Being part of MyPeBS does not change your care. For more information on MyPeBS trial and project www.mypebs.eu
Mammogram Ultrasound
Oct 2019 - -
Oct 2020 x x
Oct 2021 - -
Oct 2022 x x Bases of your risk estimation : This estimation was done using the
information you provided in your questionnaires + your breast
mammographic density + your saliva test result (Polygenic risk score (PRS))
You will receive notices for these examinations 2 months before the
scheduled timing 17/11/2018 Stakeholders & Investigators Meeting 39
What is my breast cancer risk?
Compared to the average for your age, your breast cancer risk is High
High
In this risk category, 1 in 20 to 60 women may develop
breast cancer within the next 5 years.
What personalised screening
programme is proposed for me?
The suggested screening programme for you is as follows:
Questions? If you want more detailed information on your risk estimation Please ask your investigator who will be able to provide more details If you think your risk estimate may need reevaluation Please enter new data that may change your risk 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 changed! Queries about the MyPeBS study or result You will find a FAQ on your MyPeBS personal portal. For medical questions, please ask your MyPeBS investigator or personal physician. If you have been diagnosed with breast cancer Please refer this diagnosis in your personal MyPeBS portal. Being part of MyPeBS does not change your care. You can remain on study after a diagnosis of breast cancer. For more information on MyPeBS trial and project www.mypebs.eu
Mammogram Ultrasound
Oct 2019 x x
Oct 2020 x x
Oct 2021 x x
Oct 2022 x x
You will receive notices for these examinations 2 months before the
scheduled timing
Bases of your risk estimation : This estimation was done using the
information you provided in your questionnaires + your breast
mammographic density + your saliva test result (Polygenic risk score (PRS)) 17/11/2018
Stakeholders & Investigators Meeting 40
What is my breast cancer risk?
Compared to the average for your age, your breast cancer risk is very high
Very High
In this risk category, more than 1 in 17 women may
develop breast cancer within the next 5 years.
Genetic counselling is
recommended.
What personalised screening
programme is proposed for me?
The suggested screening programme for you is as follows:
Questions? If you want more detailed information on your risk estimation Please ask your investigator who will be able to provide more details If you think your risk estimate may need reevaluation Please enter new data that may change your risk 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 changed! Queries about the MyPeBS study or result You will find a FAQ on your MyPeBS personal portal. For medical questions, please ask your MyPeBS investigator or personal physician. If you have been diagnosed with breast cancer Please refer this diagnosis in your personal MyPeBS portal. Being part of MyPeBS does not change your care. You can remain on study after a diagnosis of breast cancer. For more information on MyPeBS trial and project www.mypebs.eu
Mammogram MRI
Oct 2019 x x
Oct 2020 x x
Oct 2021 x x
Oct 2022 x x
You will receive notices for these examinations 2 months before the
scheduled timing
Bases of your risk estimation : This estimation was done using the
information you provided in your questionnaires + your breast
mammographic density + your saliva test result (Polygenic risk score (PRS))
17/11/2018 Stakeholders & Investigators Meeting 41
What is my breast cancer risk?
Compared to the average for your age, your breast cancer risk is Low
Low
In this risk category, less than 1 in 100 women may
develop breast cancer within the next 5 years.
What personalised screening
programme is proposed for me?
The suggested screening programme for you is as follows:
Questions? If you want more detailed information on your risk estimation Please ask your investigator who will be able to provide more details If you think your risk estimate may need reevaluation Please enter new data that may change your risk 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 changed! Queries about the MyPeBS study or result You will find a FAQ on your MyPeBS personal portal. For medical questions, please ask your MyPeBS investigator or personal physician. If you have been diagnosed with breast cancer Please refer this diagnosis in your personal MyPeBS portal. Being part of MyPeBS does not change your care. You can remain on study after a diagnosis of breast cancer. For more information on MyPeBS trial and project www.mypebs.eu
Mammogram Ultrasound
Oct 2019 - -
Oct 2020 - -
Oct 2021 - -
Oct 2022 x x
You will receive notices for this examination 2 months before the
scheduled timing
Bases of your risk estimation : This estimation was done using the
information you provided in your questionnaires + your breast
mammographic density + your saliva test result (Polygenic risk score (PRS)) 17/11/2018 Stakeholders & Investigators Meeting 42
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Website 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° 755394
In Belgium
45
49
Folded leaflet
Poster/billboard
50
51
Q&As
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394
Thank you for your attention!