- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02898363
Awareness on Cancer in Persons With Intellectual Disabilities (ONCODEFI)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Montpellier Cedex 5, France, 34093
- IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Refusal of study participation following provision of information (refusal by the patient, or his/her guardian, or principal caregiver)
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cancer incidence among persons with intellectual disabilities
Time Frame: Change from baseline (i.e. years -4 through -1) to years 1 through 3
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Change from baseline (i.e. years -4 through -1) to years 1 through 3
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Collaborators and Investigators
Investigators
- Study Director: Daniel Satgé, MD, PhD, IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AO-INCA/2012/DS-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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