- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03135743
Retrospective Analysis of Lymphomas and Cancers Synchronous Occurrence in Picardy From 2007 to 2012 (LYMPHOSYNCHRO)
Cancer is the leading cause of death in man and the second leading cause in women with 85,000 and 63,000 deaths, respectively, in 2012. A working group led by Holly L. Howe, PhD, in 2002 defined primary neoplasia Such as the occurrence and diagnosis of two or more independent neoplasms of different histology in the same patient. The occurrence of a new cancer has become more frequent in recent years: the prevalence of multiple primary neoplasia (NPM) is estimated between 0.73% and 11.7%. According to the French data, the risk of second cancer in people who have already had a first cancer is increased by 36% compared to the general population. Several studies have reported an increase in the risk of cancer after treatment of lymphoma but there are currently no studies on the occurrence of lymphoma and cancer of synchronous occurrence.
In our department, 19 patients presented cancer and lymphoma synchronously, that is to say 6 months between 2007 and 2012.
The main objective is to show that there is an increase in the incidence of cancers in patients diagnosed for lymphoma synchronously. Secondary objectives are to describe the clinical and biological characteristics of the patients concerned and to formulate hypotheses on the physiopathological mechanisms involved: peri-tumoral B-cell lymphoproliferation, alteration of the immune system or rearrangement of the BCR.
In a second step, the investigator could propose a multicenter epidemiological study using data from the different Cancer Registries. If results are confirmed in a larger cohort, recommendations could be made.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Picardie
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Amiens, Picardie, France, 80054
- CHU Amiens Picardie
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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:
- Being older than 18
- Have been diagnosed for Hodgkin's or non-Hodgkin's lymphoma from 1 January 2007 to 31 December 2012
- Diagnostic confirmation either in anatomopathology or in cytology
- Delay of 6 months maximum between the two neoplasms (Synchronic / metachronous distinction)
Exclusion Criteria:
- Hemopathy other than lymphoma (CLL and lymphocytic lymphoma excluded)
- Diagnosis of lymphoma outside the inclusion period Metastases and recurrences were not considered as secondary cancers, but as relapses of the first neoplasia
- Cutaneous squamous cell carcinomas were not considered secondary cancer because of the absence of available incidence data (FRANCIM network)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis of the occurrence of cancer and lymphoma within 6 months between 2007 and 2012
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2016_843_0024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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