SIGNAL - Cohort of Breast Cancer Patients. Identification of Genetic Determinants that Influence Resistance/Sensitivity and/or Toxicity to Adjuvant Cancer Treatment and Genetic Determinants for Developing Breast Cancer.
Head :
Pauporté Iris
Pivot Xavier
Cox David
Deleuze Jean-François
Blanché-Koch Hélène
Pivot Xavier
Cox David
Deleuze Jean-François
Blanché-Koch Hélène
Last update : 08/17/2016 | Version : 1 | ID : 73302
| General | |
| Identification | |
| Detailed name | Cohort of Breast Cancer Patients. Identification of Genetic Determinants that Influence Resistance/Sensitivity and/or Toxicity to Adjuvant Cancer Treatment and Genetic Determinants for Developing Breast Cancer. |
| Sign or acronym | SIGNAL |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCP 28/01/2009; ANSM: B881131-60 |
| General Aspects | |
| Medical area |
Cancer research |
| Pathology (details) | Breast cancer |
| Health determinants |
Genetic Healthcare system and access to health care services Iatrogenic Medicine |
| Keywords | genetic determinant, breast, cancer, treatment |
| Scientific investigator(s) (Contact) | |
| Name of the director | Pauporté |
| Surname | Iris |
| Address |
INSTITUT NATIONAL DU CANCER 52 AVENUE MORIZET 92513 BOULOGNE-BILLANCOURT |
| Phone | +33 (0)1.41.10.14.86 |
| ipauporte@institutcancer.fr | |
| Organization | National Cancer Institute |
| Name of the director | Pivot |
| Surname | Xavier |
| Phone | +33 (0)3 81 66 93 86 |
| Xavier.pivot@univ-fcomte.fr | |
| Organization | Besançon University Hospital |
| Name of the director | Cox |
| Surname | David |
| Phone | +33 (0)4 78 78 59 12 |
| david.cox@inserm.fr | |
| Organization | Lyon Cancer Research Centre |
| Name of the director | Deleuze |
| Surname | Jean-François |
| deleuze@cng.fr | |
| Organization | Fondation Jean Dausset-CEPH & National Genotyping Centre |
| Name of the director | Blanché-Koch |
| Surname | Hélène |
| Phone | +33 (0)1 53 72 50 42 |
| blanche@cephb.fr | |
| Organization | Fondation Jean Dausset-CEPH |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | ICGC (International Consortium of Genomics of Cancer) |
| Funding | |
| Funding status |
Public |
| Details | National Cancer Institute |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National du Cancer |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at individual level |
| Additional information regarding sample selection. |
Enrolment in healthcare facilities authorised to carry out cancer research. The physicians in charge of patient enrolment in the SIGNAL clinical trial offer breast cancer patients with overexpression or non-overexpression of the HER2 receptor the opportunity to participate in this genetic study.
3 groups are formed: Group HER2+: The HER2+ group will be made up of breast cancer patients with HER2 receptor overexpression, treated with Trastuzumab and who agreed to participate in the study. Patients treated with Trastuzumab as part of a clinical trial (e.g. PHARE) are eligible for the SIGNAL trial. Group HER2-: The HER2- group will be made up of breast cancer patients with non-overexpression of the HER2 receptor who agreed to participate in the study. Healthy Control subjects: Recruited from other cohorts. |
| Database objective | |
| Main objective |
The aims of this study are:
— to identify determinants that influence resistance or sensitivity following adjuvant treatment with Herceptin®; — to identify determinants of cardiac toxicity following adjuvant treatment with Herceptin®; — to identify genetic determinants for developing different types of breast cancer: HER2+, triple negative, RH+; — to identify genetic determinants for developing breast cancer. |
| Inclusion criteria |
1. Women over 18 years old.
2. Histologically confirmed, non-metastatic, operable breast adenocarcinoma. 3. HER2+ tumour: all patients undergoing adjuvant treatment with Trastuzumab. 4. Signed informed consent. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2017 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 9,600 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Type of treatment received; breast cancer subtype; clinical events (relapse, death); heart monitoring. |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Physical attributes; reproductive history; family history; personal medical history; family records; physical activity; exposure to tobacco and alcohol; exposure to radiation. |
| Paraclinical data (detail) | Mammography; CA15-3 (optional) |
| Biological data (detail) | Blood; tumour sample |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Plasma Tissues Cell lines DNA |
| Details of biobank content | DNA; plasma |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | By participating physicians and study investigators |
| Quality procedure(s) used | Implemented by independent operators |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by convocation of the participant |
| Details on monitoring of participants | Patients will be monitored for 5 years by: – clinical examination every 6 months – CA15-3 every 6 months (optional) – annual mammogram |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) | Fully anonymised clinical data (no initials or order number; returned to correlation table; no date of birth; no reference to the healthcare centre or investigator that enrolled the patient) may be made readily available to third parties; please contact those in charge of the study. Requesting parties undertake to reference the study and its sponsor in all publications resulting from these data. |
| Access to aggregated data |
Free access |
| Access to individual data |
Free access |
