ITMO public health
Last update : 07/10/2014 | Version : 1 | ID : 8137
| General | |
| Identification | |
| Detailed name | COHORT ON HEALTH-RELATED QUALITY OF LIFE IN GYNAECHOLOGIC ONCOLOGY |
| Sign or acronym | GYNEQOL |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Genetic Geography Social and psychosocial factors |
| Others (details) | Gynaecologic cancers |
| Keywords | Endometrial cancer, cervical cancer, vulvar cancer, ovarian cancer, quality of life, sexuality |
| Scientific investigator(s) (Contact) | |
| Name of the director | Ramanah |
| Surname | Rajeev |
| Address | 3 boulevard Fleming, 25000 BESANCON |
| Phone | +33 (0)3 81 21 89 86 |
| rajeev.ramanah@univ-fcomte.fr | |
| Unit | Pôle mère-enfant / Physiologie Cardiovasculaire (EA 3920) |
| Organization | CHRU Besançon – Université de |
| Name of the director | Paget-Bailly |
| Surname | Sophie |
| Address | 2, place Saint Jacques, 25000 BESANCON |
| spaget@chu-besancon.fr | |
| Unit | Unité Méthodologique et de Qualité de Vie en Cancérologie (EA 3181) |
| Organization | CHRU Besançon – Université de |
| Name of the director | Kalbacher |
| Surname | Elsa |
| Address | 3 boulevard Fleming, 25000 BESANCON |
| ekalbacher@chu-besancon.fr | |
| Unit | Service d'oncologie médicale |
| Organization | CHRU |
| Name of the director | Coutant |
| Surname | Charles |
| Address | 1 rue Professeur Marion, BP 77980 - 21079 Dijon cedex |
| ccoutant@cgfl.fr | |
| Organization | Centre Georges-François |
| Name of the director | Dabakuyo |
| Surname | Sandrine |
| Address | 1 rue du Pr Marion, 21079 Dijon Cedex |
| sdabakuyo@cgfl.fr | |
| Organization | Plateforme Nationale Qualité de Vie et |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | --- |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHRU Besançon – Université de Franche-Comté |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | • Main objective To study factors (clinical, biological, sociodemographic, behavioural) associated with quality of life (QoL) in real-life situations, in patients with gynecologic cancers, namely endometrial cancer, cervical cancer, vulvar and vaginal cancer and ovarian cancer. • Secondary Objectives To describe patient characteristics at baseline and compare QoL data of cohort patients with European and French data To compare QoL of patients who have undergone surgery for endometrial and cervical cancer according to different surgical approaches: Laparoscopy versus laparotomy Robot-assisted versus conventional laparoscopic surgery To assess QoL over time and for the "long-term" in patients with ovarian cancer, particularly those receiving intraperitoneal perioperatory adjuvant chemotherapy To assess the impact of targeted therapies on the QoL of patients with cervical and ovarian cancer To analyse time up to QoL deterioration in ovarian cancer and to research factors associated with deterioration To determine if QoL is different depending on the histological type of endometrial cancer To compare QoL of patients who have received and have not received adjuvant CT after surgery and radiotherapy for endometrial cancer To evaluate the importance of early palliative care patients in QoL Validation of SAQ sexuality questionnaire in French |
| Inclusion criteria | Selected pelvic cancers are cervical, uterine body, ovarian, vaginal and vulvar cancer, irrespective of histological type and stage: - Follow-up in Franche-Comté and the Georges François Leclerc Centre in Dijon - Age: 18 years and over - good knowledge of French - Able to respond to questionnaires (no major cognitive impairment) - Living in Franche Comté and Burgundy at time of diagnosis - having given signed consent - Covered by Social Security |
| 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 |
Regional |
| French regions covered by the database |
Bourgogne Franche-Comté |
| Detail of the geography area | Franche-Comté - Burgundy |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2015 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | --- |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Biological data (detail) | Biomarkers |
| Administrative data (detail) | Socio-demographic data: year and place of birth, nationality, level of education, marital status, socio-professional group (according to INSEE PCS), employment (employment/unemployment/inactivity), annual income |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Minium 24 months |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23669416 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22426405 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23669416 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22426405 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23669416 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22426405 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23669416 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22426405 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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