Cancercancer observNCT03687151
Population-based Cancer Observatory
An observational study of Cancer, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Cancer is the leading cause of death in Western countries. In France cancer control plans (National screening programmes) and recommendations for the management of cancer patients (multidisciplinary team meetings), have been implemented. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- non intervention / observationnal
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2005to 31 Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient with cancer
Who may be able to join
- All subjects with a diagnosis of invasive or in situ cancer living in the French Region Sud-Provence-Alpes-Côte d'Azur.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nice University Hospital
Nice, 06000
eugenia MARINE BARJOAN, PH, 33492035635, marine-barjoan.e@chu-nice.fr
laurent BAILLY, PH, 33492035635, bailly.l@chu-nice.fr
About this study
Official title: Population-based Cancer Observatory of the French Region Sud-Provence-Alpes-Côte d'Azur Recruiting Incident Cases of Cancer Since 2005
Cancer is the leading cause of death in Western countries. In France cancer control plans (National screening programmes) and recommendations for the management of cancer patients (multidisciplinary team meetings), have been implemented. Evaluating the effectiveness of these policies aiming for improved prevention and management is essential. However to conduct such an evaluation, a baseline reference requiring ongoing, reliable and complete data collection is necessary and can be used for epidemiological research.
There is no cancer registry in the French Region Sud-Provence-Alpes-Côte d'Azur. In view of this situation, the regional Health Agency appointed the public health department of the Nice Côte d'Azur University and the Centre for computerized pathology data collection (CRISAP-PACA) to develop a Cancer Observatory. Since 2005, the public health department collects data concerning invasive and in situ cancers from all the histopathology labs in the French Region Sud-Provence-Alpes-Côte d'Azur, gathered in the CRISAP-PACA, and transmits incidence cancer rates to the regional Health Agency. In 2007, a quality control procedure, comparing a random sample of data collected by the Cancer Observatory with pathology lab reports, confirmed the validity of the collected data with fewer than 3% in disagreement with the report's conclusions. In 2008, the estimated completeness of cancer records collected from histopathology laboratories was higher than 90% for new cases of breast and colorectal cancer within the age range concerned by the screening programme. Since 2012, public and private hospitals treating cancer patients as well as the regional cancer network ONCOPACA, coordinating multiple team meetings, have been contacted to transmit to the public health department cases of cancer without histological diagnosis. In addition, patients with cancer have been geolocated to study the influence of environmental exposures on the occurrence of cancers (patients living near of waste incinerator, highways).
- Conditions
- Cancer
- Being tested
- non intervention / observationnal
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non intervention / observationnalOther
non intervention / observationnal
| Study group | Role | What they receive |
|---|---|---|
| patients with a diagnosis of invasive or in situ cancer | patients with a diagnosis of invasive or in situ cancer living in the French Region Sud-Provence-Alpes-Côte d'Azur since 2005 Receives: Other: non intervention / observationnal |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of each cancer of the French Region Sud-Provence-Alpes-Côte d'Azur
each cancer is definite by :number of Date of diagnosis, Tumor location, Histology, ADICAP codes, CIM-O codes, Age, Gender and Geolocation.
number of classification of cancer.
Measured: 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Jan 2005
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687151
- Sponsor's protocol ID
- 18-DSP-04
- Acronym
- cancer observ
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-based Cancer Observatory of the French Region Sud-Provence-Alpes-Côte d'Azur Recruiting Incident Cases of Cancer Since 2005
- ClinicalTrials.gov ID
- NCT03687151
- Acronym / sponsor ID
- cancer observ / 18-DSP-04
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer is the leading cause of death in Western countries. In France cancer control plans (National screening programmes) and recommendations for the management of cancer patients (multidisciplinary team meetings), have been implemented. Evaluating the effectiveness of these policies aiming for improved prevention and management is essential. However to conduct such an evaluation, a baseline reference requiring ongoing, reliable and complete data collection is necessary and can be used for epidemiological research.
There is no cancer registry in the French Region Sud-Provence-Alpes-Côte d'Azur. In view of this situation, the regional Health Agency appointed the public health department of the Nice Côte d'Azur University and the Centre for computerized pathology data collection (CRISAP-PACA) to develop a Cancer Observatory. Since 2005, the public health department collects data concerning invasive and in situ cancers from all the histopathology labs in the French Region Sud-Provence-Alpes-Côte d'Azur, gathered in the CRISAP-PACA, and transmits incidence cancer rates to the regional Health Agency. In 2007, a quality control procedure, comparing a random sample of data collected by the Cancer Observatory with pathology lab reports, confirmed the validity of the collected data with fewer than 3% in disagreement with the report's conclusions. In 2008, the estimated completeness of cancer records collected from histopathology laboratories was higher than 90% for new cases of breast and colorectal cancer within the age range concerned by the screening programme. Since 2012, public and private hospitals treating cancer patients as well as the regional cancer network ONCOPACA, coordinating multiple team meetings, have been contacted to transmit to the public health department cases of cancer without histological diagnosis. In addition, patients with cancer have been geolocated to study the influence of environmental exposures on the occurrence of cancers (patients living near of waste incinerator, highways).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a diagnosis of invasive or in situ cancer | – | Other: non intervention / observationnalpatients with a diagnosis of invasive or in situ cancer living in the French Region Sud-Provence-Alpes-Côte d'Azur since 2005 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient with cancer
Key inclusion criteria (1 listed)
- All subjects with a diagnosis of invasive or in situ cancer living in the French Region Sud-Provence-Alpes-Côte d'Azur.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non intervention / observationnalnon intervention / observationnal | Other | patients with a diagnosis of invasive or in situ cancer |
Primary outcome
number of each cancer of the French Region Sud-Provence-Alpes-Côte d'Azur
Time frame: 50 years
each cancer is definite by :number of Date of diagnosis, Tumor location, Histology, ADICAP codes, CIM-O codes, Age, Gender and Geolocation. number of classification of cancer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact eugenia MARINE BARJOAN, PH (33492035635, marine-barjoan.e@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of each cancer of the French Region Sud-Provence-Alpes-Côte d'Azur (time frame: 50 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.