Cohort of Tumors With POLE/D1 Mutation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFederation Francophone de Cancerologie Digestive
About this trial
Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)/POLD1 mutation identified by molecular biology platforms for all stages and primary sites combined
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any tumor presenting a variant of the exonuclease domain of POLE (exons 9 to 14) classified as pathogenic by the project working group, including: the 4 hotspots of mutations described (codons 286 (P286R/H/L), 411 (V411L), 459 (S459F), 424 (L424/V/I), (2).
Any tumor presenting a variant of the exonuclease domain of PolD1 (exons 8-12), classified as pathogenic by the project working group, including : C319Y(10).
Disqualifiers
Tumor without POLE or POLD1 mutation
Tumor with POLE mutation identified in research studies retrospective research
Opposition of the patient to the registration of his data in the cohort
Trial population
\- Patient with a histologically proven tumor with a POLE or POLD1 mutation identified by molecular biology analysis, carried out within the framework of clinical practice in the platforms that have set up this research.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE/POLD1 mutation identified by molecular biology platforms for all stages and primary sites
Collection and description of clinical and histo-pathological data of tumors with POLE/POLD1 mutation
Time frame
October 20272
Molecular characterization of the identified POLE/POLD1 mutations
Molecular characterization of the identified POLE/POLD1 mutations and of the mutational profile associated with these mutations
Time frame
October 20273
Overall survival and response to treatments
Analysis of overall survival and response to treatments (chemotherapies, immunotherapies...)
Time frame
October 2027Secondary outcomes
1
database and block librabry
Establishment of a database of somatic POLE variants Establishment of a block library of POLE mutated tumors
Time frame
October 2027Sponsors and contacts
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Source ClinicalTrials.gov