CancerONCODEFINCT02898363
Awareness on Cancer in Persons With Intellectual Disabilities
An observational study of Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Context People with intellectual disability (PWIDs), nearly 1,300,000 adults and children in France, develop as many cancers as persons in the general population. However, their tumors are different by their particular organ distribution, the age of onset, the biological background (2,000 genetic conditions are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Information campaign
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is all adults with intellectual disabilities residing in the Hérault department of France who have been diagnosed with cancer
Who may be able to join
- Persons with intellectual disabilities according to the World Health Organization definition
- Residing in the Hérault department of France
- Diagnosis of a malign invasive or in-situ tumor
Who cannot join
- Refusal of study participation following provision of information (refusal by the patient, or his/her guardian, or principal caregiver)
Trial locations and contacts
1 site in 1 country.
France1 site
IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique
Montpellier, 34093
About this study
Context People with intellectual disability (PWIDs), nearly 1,300,000 adults and children in France, develop as many cancers as persons in the general population. However, their tumors are different by their particular organ distribution, the age of onset, the biological background (2,000 genetic conditions are associated with an intellectual disability) and above all the unusual clinical presentation. These cancers are not well known from physicians, carers and families, and often discovered late. A recent review of the literature shows many inequalities in the prevention, monitoring, screening, diagnosis and treatment of cancer in these patients. Currently, no population study on clinical features and stage at diagnosis of cancer in PWIDs is available. No interventional research study has been conducted on this subject.
Hypothesis Investigators hypothesize that inequalities in cancer care of PWIDs do not result from a direct link between intellectual disability and cancer, but are related to diagnosis difficulties of these tumors which are not well known, and to difficulties of communication with these patients who do not express easily their symptoms, particularly pain.
Read the detailed description
The study will first evaluate characteristics of all cancers diagnosed in PWIDs in the department of Hérault (20,000 PWIDs) during the four-year period preceding the intervention. Investigators will cross the data of social network of PWIDs (CREAI Languedoc Roussillon) which covers nearly 90% of PWIDs living in this area, and the Hérault Cancer Registry. Second, during a two-year information program, physicians, mainly general practitioners, carers in and outside institutions, associations and families will be informed on cancer frequency, on cancer particularities and on cancer detection in PWIDs by the mean of documents, mails and e-mails, meetings and a website providing all available useful information on cancer in PWIDs. Third, characteristics of tumors observed during the three years after the beginning of the intervention will be statistically compared to the corresponding tumors before the intervention. This will be done especially for colon cancer and breast cancer using the TNM stage and the used therapeutic means. On the basis of the first part of the study, if a significant difference on stage at diagnosis and treatment is observed compared to the general population, other tumors will also be included in the comparison, if relevant.
- Conditions
- Cancer
- Being tested
- Information campaign
- Keywords
- Care of disabled population, Mental retardation, Cancer screening, Cancer prevention
- Medical subject headings
- Neoplasms, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information campaignOther
During a two-year information program, physicians, mainly general practitioners, carers in and outside institutions, associations and families will be informed on cancer frequency, on cancer particularities and on cancer detection in persons with intellectual disabilities by means of documents, mails and e-mails, meetings and a website providing all available useful information on cancer in persons with intellectual disabilities.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer incidence among persons with intellectual disabilities
Measured: Change from baseline (i.e. years -4 through -1) to years 1 through 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startMar 2013
- Primary completionSep 2016
- Study completionSep 2016
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Satgé, MD, PhD, Study director, IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898363
- Sponsor's protocol ID
- AO-INCA/2012/DS-01
- Acronym
- ONCODEFI
- Status last verified
- Jan 2017
- First submitted
- 8 Sep 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness on Cancer in Persons With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT02898363
- Acronym / sponsor ID
- ONCODEFI / AO-INCA/2012/DS-01
- Conditions
- Cancer
- Keywords
- Care of disabled population, Mental retardation, Cancer screening, Cancer prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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.
Context People with intellectual disability (PWIDs), nearly 1,300,000 adults and children in France, develop as many cancers as persons in the general population. However, their tumors are different by their particular organ distribution, the age of onset, the biological background (2,000 genetic conditions are associated with an intellectual disability) and above all the unusual clinical presentation. These cancers are not well known from physicians, carers and families, and often discovered late. A recent review of the literature shows many inequalities in the prevention, monitoring, screening, diagnosis and treatment of cancer in these patients. Currently, no population study on clinical features and stage at diagnosis of cancer in PWIDs is available. No interventional research study has been conducted on this subject.
Hypothesis Investigators hypothesize that inequalities in cancer care of PWIDs do not result from a direct link between intellectual disability and cancer, but are related to diagnosis difficulties of these tumors which are not well known, and to difficulties of communication with these patients who do not express easily their symptoms, particularly pain.
Detailed description
The study will first evaluate characteristics of all cancers diagnosed in PWIDs in the department of Hérault (20,000 PWIDs) during the four-year period preceding the intervention. Investigators will cross the data of social network of PWIDs (CREAI Languedoc Roussillon) which covers nearly 90% of PWIDs living in this area, and the Hérault Cancer Registry. Second, during a two-year information program, physicians, mainly general practitioners, carers in and outside institutions, associations and families will be informed on cancer frequency, on cancer particularities and on cancer detection in PWIDs by the mean of documents, mails and e-mails, meetings and a website providing all available useful information on cancer in PWIDs. Third, characteristics of tumors observed during the three years after the beginning of the intervention will be statistically compared to the corresponding tumors before the intervention. This will be done especially for colon cancer and breast cancer using the TNM stage and the used therapeutic means. On the basis of the first part of the study, if a significant difference on stage at diagnosis and treatment is observed compared to the general population, other tumors will also be included in the comparison, if relevant.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is all adults with intellectual disabilities residing in the Hérault department of France who have been diagnosed with cancer
Key inclusion criteria (3 listed)
- Persons with intellectual disabilities according to the World Health Organization definition
- Residing in the Hérault department of France
- Diagnosis of a malign invasive or in-situ tumor
Key exclusion criteria (1 listed)
- Refusal of study participation following provision of information (refusal by the patient, or his/her guardian, or principal caregiver)
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 |
|---|---|---|
| Information campaignDuring a two-year information program, physicians, mainly general practitioners, carers in and outside institutions, associations and families will be informed on cancer frequency, on cancer particularities and on cancer detection in persons with intellectual disabilities by means of documents, mails and e-mails, meetings and a website providing all available useful information on cancer in persons with intellectual disabilities. | Other | – |
Primary outcome
Cancer incidence among persons with intellectual disabilities
Time frame: Change from baseline (i.e. years -4 through -1) to years 1 through 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
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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. This study is not recruiting at the moment.
Daniel Satgé, MD, PhD study director
IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique
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 Nīmes 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 3 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: finished, as of the sponsor's last update on 31 Jan 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer incidence among persons with intellectual disabilities (time frame: Change from baseline (i.e. years -4 through -1) to years 1 through 3). 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 31 Jan 2017.