CAPTURE - An Observational study to assess the burden of illness in prostate cancer patients with low to moderate risk of progression
Head :
Leclerc-Zwirn Christel, Laboratoire GSK
Last update : 09/07/2020 | Version : 1 | ID : 148
| General | |
| Identification | |
| Detailed name | An Observational study to assess the burden of illness in prostate cancer patients with low to moderate risk of progression |
| Sign or acronym | CAPTURE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 90 93 05 |
| General Aspects | |
| Medical area |
Cancer research Urology, andrology and nephrology |
| Pathology (details) | quality of life |
| Keywords | prostate, cancer |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leclerc-Zwirn |
| Surname | Christel |
| Phone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Unit | Laboratoire GSK |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Laboratoire GSK |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Laboratoire GSK |
| Organisation status |
Private |
| 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 care professionals A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Subjects with a diagnosis of low-to-moderate risk PCa will be enrolled and recruitment tracked using an Interactive Voice Recognition System (IVRS) to ensure that at least 670 subjects are enrolled and evenly distributed at 134 subjects per country from France, Germany, Italy, Spain and Sweden |
| Database objective | |
| Main objective |
• To assess the impact of low-to-moderate risk PCa on the subject’s QoL and
anxiety/depression at diagnosis and within the first year of treatment. • To estimate health care consumption and utility values within the first year of diagnosis of subjects with low-to-moderate risk PCa. • To describe the profile and medical management of subjects with low-to-moderate risk PCa from 5 countries in the European Union (EU), (France, Germany, Italy, Spain and Sweden). |
| Inclusion criteria |
1. Demography: Males aged between 50-75 years.
2. Disease characteristics: Gleason score ≤7, PSA ≤20, and clinical staging T1c-T2b (according to D’Amico criteria of low-intermediate risk [D'Amico, 1998]). 3. Informed consent: Subject is willing and able to provide written informed consent. 4. Literacy: Able to read and write in order to complete the study questionnaires. |
| Population type | |
| Age |
Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male |
| Geography area |
International |
| Detail of the geography area | France, Germany, Italy,Spain and Sweden |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 116 (France) |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | This study will utilize 3 QoL and two additional questionnaires as summarized below:• QLQ-C30 and QLQ-PR25.• EQ-5D.• HADS.• Work Productivity Assessment Index (WPAI).Subjects will be asked to complete the questionnaires in the following order: QLQC30/QLQ-PR25, EQ-5D, HADS, and WPAI. The physician will be asked to complete arunning log of Prostate resource usage. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 3, 6 and 12 months after the first inclusion visit |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publication on going |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
