Genetic Information

Gene & Transcript Details

Gene
TP53
Transcript
NM_000546.5 MANE Select
Total Exons
Reference Sequence
NC_000017.10
Alternative Transcripts
IDStatusDetails
NM_000546.3 Alternative 2640 nt | 252–1433
NM_000546.5 RefSeq Select 2591 nt | 203–1384
NM_000546.6 MANE Select 2512 nt | 143–1324
NM_000546.4 Alternative 2586 nt | 198–1379
NM_000546.2 Alternative 2629 nt | 252–1433

Variant Details

HGVS Notation
NM_000546.5:c.743G>T
Protein Change
R248L
Location
Exon 7 (Exon 7 of )
7
5'Exon Structure3'
Functional Consequence
Loss of Function
Alternate Identifiers

Clinical & Population Data

Population Frequency

gnomAD
Global Frequency
0.0 in 100,000
Extremely Rare
ACMG Criteria Applied PM2
This variant is absent or extremely rare in population databases (PM2 criteria applies).

ClinVar

Open
Classification
Likely Pathogenic
2 publications
Publications List
PMID: 11793474

The p.R248L pathogenic mutation (also known as c.743G>T), located in coding exon 6 of the TP53 gene, results from a G to T substitution at nucleotide position 743. The arginine at codon 248 is replaced by leucine, an amino acid with dissimilar properties. This variant has been reported in a cohort of Chinese individuals at an high risk for breast cancer (Li JY et al. Int J Cancer, 2019 Jan;144:281-289). This variant has been detected in at least one individual at an allele fraction that is suggestive of clonal hematopoiesis, a predictor of TP53 pathogenicity (Ambry internal data; Fortuno C et al. Genet Med. 2022 03;24:673-680). This variant is in the DNA binding domain of the TP53 protein and is reported to have non-functional transactivation in yeast based assays (Kato S et al. Proc Natl Acad Sci U S A, 2003 Jul;100:8424-9; Dearth LR et al. Carcinogenesis, 2007 Feb;28:289-98; Jordan JJ et al. Mol Cancer Res, 2010 May;8:701-16). Studies conducted in human cell lines indicate this alteration is deficient at growth suppression and has a dominant negative effect (Kotler E et al. Mol.Cell. 2018 Jul;71:178-190.e8;,Giacomelli AO et al. Nat. Genet. 2018 Oct;50:1381-1387). This alteration is located at a position or in a region that is critical for protein function (Ambry internal data). This amino acid position is highly conserved in available vertebrate species. In addition, this alteration is predicted to be deleterious by in silico analysis. Based on the supporting evidence, this alteration is interpreted as a disease-causing mutation.

PMID: 29752822

This sequence change replaces arginine, which is basic and polar, with leucine, which is neutral and non-polar, at codon 248 of the TP53 protein (p.Arg248Leu). This variant is not present in population databases (gnomAD no frequency). This missense change has been observed in individual(s) with breast cancer (PMID: 29752822). ClinVar contains an entry for this variant (Variation ID: 230253). Invitae Evidence Modeling incorporating data from in vitro experimental studies (PMID: 12826609, 29979965, 30224644) indicates that this missense variant is expected to disrupt TP53 function with a positive predictive value of 97.5%. Experimental studies have shown that this missense change affects TP53 function (PMID: 9290701, 12826609, 20407015, 25584008). In summary, the currently available evidence indicates that the variant is pathogenic, but additional data are needed to prove that conclusively. Therefore, this variant has been classified as Likely Pathogenic.

PMID: 29979965

This variant is considered likely pathogenic. Functional studies indicate this variant impacts protein function [PMID: 29979965, 8062826, 25584008]. This variant is expected to disrupt protein structure [Myriad internal data].

Clinical Statement

"This variant has been reported in ClinVar as Pathogenic (1 clinical laboratories) and as Likely pathogenic (4 clinical laboratories) and as Pathogenic by ClinGen TP53 Variant Curation Expert Panel, ClinGen expert panel."

COSMIC Somatic Evidence

Open
COSMIC ID
COSM241996
Recurrence
156 occurrences
PM1 Criteria
Applied
COSMIC Database Preview
COSMIC Preview
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Functional Impact & Domains

Functional Domain

Hotspot Status
Not a hotspot
Domain Summary
This variant is not located in a mutational hotspot or critical domain.
Related Variants in This Domain
No evidence of other pathogenic variants at this position in gene TP53.

Functional Studies & Therapeutic Relevance

Functional Summary

Error in OpenAI Consolidation. OncoKB: TP53R248LTP53R248LSomaticNCBI Gene:7157|Show additional gene information Variant OverviewTP53, a tumor suppressor in the DNA damage pathway, is the most frequently mutated gene in cancer.The TP53 R248L mutation is likely oncogenic.Hide mutation effect description The TP53 R248L mutation is located in the protein's DNA binding domain. Expression of this mutant in TP53-null cells resulted in decreased transactivation of p53 target genes, as a measured by a luciferase reporter assay (PMID: 25584008). Additionally, the TP53 R248L mutation failed to suppress colony growth in a colony reduction assay compared to wildtype TP53 (PMID: 25584008). Ovarian cancer patient samples and mouse models expressing this mutation were sensitive to an amyloid aggregate TP53 inhibitor as evidenced by apoptosis assays. Some TP53 mutations have been shown to form amyloid aggregates that leads to inactivation of the TP53 protein. Responsiveness of this variant to amyloid aggregate inhibitors suggest that this is a loss-of-function mutation (PMID: 26748848). JAX-CKB: TP53 R248L is a hotspot mutation that lies within the DNA-binding domain of the Tp53 protein (PMID: 22713868). R248L results in decreased Tp53 transactivation and repression, and resistance to apoptosis in cell culture (PMID: 8336941, PMID: 20570896, PMID: 18566217).

Database Previews
OncoKB
OncoKB Preview
JAX-CKB
JAX-CKB Preview

Click on previews to view full database entries. External databases may require institutional access.

Computational Analysis

Pathogenicity Predictions

SpliceAI
Predictor Consensus
Mixed/VUS
PP3 Applied
No
REVEL Score
0.0
Threshold: ≥0.75 = PP3 applied

SpliceAI Scores

Window: ±500bp
Effect Type Score Position
- Acceptor Loss (AL) 0.01 23 bp
- Donor Loss (DL) 0.0 -39 bp
+ Acceptor Gain (AG) 0.0 -407 bp
+ Donor Gain (DG) 0.0 31 bp
High impact (≥0.5) Medium impact (0.2-0.49) Low impact (<0.2)

VCEP Guidelines

Applied ACMG/AMP Criteria (VCEP Specific)

Filter Criteria:
PS3

PS3 (Unknown (Pre-LLM))

From pre-LLM assessment (LLM Failed)

PM2

PM2 (Unknown (Pre-LLM))

From pre-LLM assessment (LLM Failed)

PP5

PP5 (Unknown (Pre-LLM))

From pre-LLM assessment (LLM Failed)

BP4

BP4 (Unknown (Pre-LLM))

From pre-LLM assessment (LLM Failed)