POLE

Chr 12ADAR

DNA polymerase epsilon, catalytic subunit

Also known as: CRCS12, FILS, IMAGEI, POLE1

The protein is the catalytic subunit of DNA polymerase epsilon, which performs chromosomal DNA replication and has 3'-5' proofreading exonuclease activity that corrects replication errors. Mutations cause FILS syndrome (facial dysmorphism, immunodeficiency, livedo, and short stature), IMAGE-I syndrome, and predisposition to colorectal cancer. The gene shows both autosomal dominant and autosomal recessive inheritance patterns and is highly constrained against loss-of-function variants.

Summary from RefSeq, OMIM, UniProt
Research Assistant →

Primary Disease Associations & Inheritance

{Colorectal cancer, susceptibility to, 12}MIM #615083
AD
FILS syndromeMIM #615139
AR
IMAGE-I syndromeMIM #618336
AR
UniProtColorectal cancer 12
UniProtFacial dysmorphism, immunodeficiency, livedo, and short stature
UniProtIntrauterine growth retardation, metaphyseal dysplasia, adrenal hypoplasia congenita, genital anomalies, and immunodeficiency
12
Active trials
2017
Pubs (1 yr)
32
P/LP submissions
0%
P/LP missense
0.64
LOEUF
LOF
Mechanism· G2P
Clinical SummaryPOLE
🧬
Gene-Disease Validity (ClinGen)
POLE-related polyposis and colorectal cancer syndrome · ADDefinitive

Definitive — sufficient evidence for diagnostic panels

Population Constraint (gnomAD)
Low constraint (pLI 0.00) — loss-of-function variants are relatively tolerated in the population.
📋
ClinVar Variants
32 unique Pathogenic / Likely Pathogenic· 153 VUS of 300 total submissions
💊
Clinical Trials
12 active or recruiting trials — potential therapeutic options may be available
📖
GeneReview available — POLE
Authoritative clinical overview · Recommended first read
Open GeneReview ↗

Population Genetics & Constraint

gnomAD v4 — loss-of-function & missense intolerance

Tolerant — LoF & missense variants common in population
LoF Constraint
0.64LOEUF
pLI 0.000
Z-score 4.94
OE 0.52 (0.420.64)
Tolerant

Typical tolerance to LoF variation

Missense Constraint
1.07Z-score
OE missense 0.92 (0.880.96)
1287 obs / 1399.1 exp
Tolerant

Mild missense constraint

Observed / Expected Ratios
LoF OE0.52 (0.420.64)
00.351.4
Missense OE0.92 (0.880.96)
00.61.4
Synonymous OE1.05
01.21.6
LoF obs/exp: 64 / 123.1Missense obs/exp: 1287 / 1399.1Syn Z: -1.01
Curated Mechanism (G2P)Gene2Phenotype (DDG2P) ↗
strongPOLE-related IMAGE syndrome with variable immunodeficiencyLOFAR
strongPOLE-related polymerase proofreading-associated polyposisOTHERAD
DN
0.6259th %ile
GOF
0.4085th %ile
LOF
0.3453th %ile

The highest-scoring mechanism for this gene is dominant-negative.

DNprediction above median

Note: In-silico variant effect predictors (SIFT, PolyPhen, REVEL, CADD) may underestimate pathogenicity of missense variants in genes with GOF or DN mechanisms. Consider functional evidence and clinical context.

Predictions from Badonyi M, Marsh JA. PLoS ONE. 2024;19(8):e0307312.

ClinVar Variant Classifications

300 submitted variants in ClinVar

Classification Summary

Pathogenic26
Likely Pathogenic6
VUS153
Likely Benign113
Benign1
Conflicting1
26
Pathogenic
6
Likely Pathogenic
153
VUS
113
Likely Benign
1
Benign
1
Conflicting

Curated Variants Distribution

Classified variants from ClinVar · 5 ACMG categories

ClassificationLoFMissense + InframeNon-codingSynonymousTotal
Pathogenic
15
0
11
0
26
Likely Pathogenic
6
0
0
0
6
VUS
3
132
15
3
153
Likely Benign
0
0
66
47
113
Benign
0
0
1
0
1
Conflicting
1
Total241329350300

LoF = frameshift, stop gained/lost, canonical splice · Counts from ClinVar esearch · Updated hourly

View in ClinVar →

Protein Context — Lollipop Plot

POLE · protein map & ClinVar variants

Showing all ClinVar variants across the protein. Search a specific variant to highlight its position.

Clinical Trials

Active and recruiting trials from ClinicalTrials.gov

GastricColorectal Adenocarcinoma

Chemotherapy Sequential Tislelizumab After Radical Resection in Patients With dMMR/MSI-H or POLE/POLD1 Mutations

NOT YET RECRUITING
NCT06118658Phase PHASE2China Medical University, ChinaStarted 2023-11-01
tislelizumab
Advanced Non-small Cell Lung CancerHER2 Mutation

A Study to Learn More About How Well Sevabertinib (BAY 2927088) Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

RECRUITING
NCT06452277Phase PHASE3BayerStarted 2024-08-28
BAY2927088PembrolizumabCisplatin
Endometrial Cancer

An Observational Study of Molecular profIling of Advanced and aggRessive ENdometrial Cancer and 1-st Line Treatment Approaches in Russian Federation

RECRUITING
NCT07041606AstraZenecaStarted 2025-06-24
Aging

Study of the Evolution of the Expression of the LAMP-2 Protein During the Advance in Age

RECRUITING
NCT06357923Phase NACentre Hospitalier Universitaire de NiceStarted 2024-09-26
dosage
Advanced Solid Tumor

A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)

RECRUITING
NCT03767075Phase PHASE2Vall d'Hebron Institute of OncologyStarted 2018-12-10
AtezolizumabFutibatinibAmivantamab
Lymphoma, Non-HodgkinMultiple MyelomaAdvanced Solid Tumors

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

RECRUITING
NCT02693535Phase PHASE2American Society of Clinical OncologyStarted 2016-03-14
PalbociclibSunitinibTemsirolimus
Familial Adenomatous Polyposis (FAP)Attenuated Familial Adenomatous Polyposis (AFAP)MUTYH-Associated Polyposis (MAP)

Familial Adenomatous Poliposys Italian Network (Rete Italiana Poliposi Adenomatosa Familiare)

ACTIVE NOT RECRUITING
NCT07461246Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoStarted 2024-05-13
Endometrial CancerFertility

Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification

RECRUITING
NCT07319429Phase PHASE2, PHASE3Fudan UniversityStarted 2026-01-25
PD1 antibodyMedroxyprogesterone Acetate 500 MGMegestrol Acetate 160 MG
TumorsPOLE Exonuclease Domain MutationPOLD1 Gene Mutation

Cohort of Tumors With POLE/D1 Mutation

RECRUITING
NCT05103969Federation Francophone de Cancerologie DigestiveStarted 2021-10-05
Functional Mitral RegurgitationHeart FailureMitral Valve Insufficiency

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

RECRUITING
NCT03142152Phase NACardiac Dimensions, Inc.Started 2018-01-01
Carillon Mitral Contour SystemGuideline Directed Heart Failure Medication
Endometrial Cancer, Endometrial Neoplasm

Precision Medicine Applied to the Study of Endometrial Cancer: Application of NGS for Molecular Classification

NOT YET RECRUITING
NCT07006103Hospital Italiano de Buenos AiresStarted 2025-06
Endometrial Cancer

Improving Endometrial Cancer Assessment by Combining Genomic Profiling and Surgical Assessment

RECRUITING
NCT06354738Phase NAUniversity Hospital, GasthuisbergStarted 2023-01-16
total hysterectomy with bilateral salpingo-oophorectomy, lymph node staging and comprehensive peritoneal staging
Clinical Literature
Open Research Assistant →
Full-Text Mentions
NLP-detected gene mentions in article bodies · via PubTator3
PubTator3
Top 5 full-text resultsSearch PubTator3 ↗
Key Publications
Landmark & review papers · by relevance
PubMed
Top 5 results · since 2015Search PubMed ↗