Clinical trial · Observational
Cohort of Tumors With POLE/D1 Mutation
Multicenter Prospective Cohort of Tumors With Pole/D1 Mutation
NCT05103969CI-TRIAL-00078635unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| POLD1 Gene Mutation | — | UNRESOLVED | — |
| POLE Exonuclease Domain Mutation | — | UNRESOLVED | — |
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- 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
- timeFrame
- October 2027
- description
- Collection and description of clinical and histo-pathological data of tumors with POLE/POLD1 mutation
- measure
- Molecular characterization of the identified POLE/POLD1 mutations
- timeFrame
- October 2027
- description
- Molecular characterization of the identified POLE/POLD1 mutations and of the mutational profile associated with these mutations
- measure
- Overall survival and response to treatments
- timeFrame
- October 2027
- description
- Analysis of overall survival and response to treatments (chemotherapies, immunotherapies...)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Diagnosis made from the date of launch of the cohort and in the previous year -Age ≥ 18 years Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.