Genetic Information

Gene & Transcript Details

Gene
TP53
Transcript
NM_000546.6 MANE Select
Total Exons
Reference Sequence
NC_000017.10
Alternative Transcripts
IDStatusDetails
NM_000546.5 RefSeq Select 2591 nt | 203–1384
NM_000546.3 Alternative 2640 nt | 252–1433
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_000546.6:c.97-11C>G
Protein Change
?
Location
Exon 3 (Exon 3 of )
3
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: 11420676

This sequence change falls in intron 3 of the TP53 gene. It does not directly change the encoded amino acid sequence of the TP53 protein. This variant is not present in population databases (gnomAD no frequency). This variant has been observed in individuals with Li-Fraumeni syndrome (PMID: 11420676, 24382691, 28681140). It has also been observed to segregate with disease in related individuals. This variant is also known as IVS3-11 C>G. ClinVar contains an entry for this variant (Variation ID: 638852). RNA analysis provides insufficient evidence to determine the effect of this variant on TP53 splicing (Invitae). For these reasons, this variant has been classified as Pathogenic.

Clinical Statement

"This variant has been reported in ClinVar as Pathogenic (2 clinical laboratories) and as Likely pathogenic (1 clinical laboratories)."

COSMIC Somatic Evidence

Open
COSMIC ID
COSN1201754
Recurrence
4 occurrences
PM1 Criteria
Not 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

The TP53 97-11c>G variant has not been functionally characterized, and its biological significance remains unknown.

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
Yes
REVEL Score
0.0
Threshold: ≥0.75 = PP3 applied

SpliceAI Scores

Window: ±500bp
Effect Type Score Position
- Acceptor Loss (AL) 0.59 -11 bp
- Donor Loss (DL) 0.01 -289 bp
+ Acceptor Gain (AG) 0.97 -1 bp
+ Donor Gain (DG) 0.0 -89 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:
PVS1

PVS1 (Not Applied)

According to VCEP guidelines, PVS1 applies only to canonical splice variants (±1,2 intronic positions) or validated null mechanisms. The variant c.97-11C>G is outside the ±1,2 positions and lacks experimental RNA evidence. Therefore, PVS1 is not applied.

PS1

PS1 (Not Applied)

According to VCEP guidelines, PS1 applies when a variant results in the same amino acid change as a known pathogenic variant. c.97-11C>G is intronic with no amino acid change. Therefore, PS1 is not applied.

PS2

PS2 (Not Applied)

According to VCEP guidelines, PS2 requires confirmed de novo occurrence with parental testing. No de novo data are available. Therefore, PS2 is not applied.

PS3

PS3 (Not Applied)

According to VCEP guidelines, PS3 requires well-validated functional assay evidence of loss of function. No functional studies are available for this variant. Therefore, PS3 is not applied.

PS4

PS4 (Not Applied)

According to VCEP guidelines, PS4 requires proband case points for LFS-associated cancers. No case-level data are available. Therefore, PS4 is not applied.

PM1

PM1 (Not Applied)

According to VCEP guidelines, PM1 applies to missense variants in TP53 hotspot codons. c.97-11C>G is intronic. Therefore, PM1 is not applied.

PM2

PM2 (Supporting)

According to VCEP guidelines, PM2 Supporting: "Variant should have an allele frequency of less than 0.00003 in gnomAD...". The variant is absent from gnomAD (MAF=0%). Therefore, PM2 is applied at Supporting strength.

PM3

PM3 (Not Applied)

According to standard ACMG/AMP guidelines, PM3 applies to recessive gene inheritance with trans observations. TP53 is autosomal dominant and no trans data exist. Therefore, PM3 is not applied.

PM4

PM4 (Not Applied)

According to standard ACMG/AMP guidelines, PM4 applies to protein length changes from in-frame indels. c.97-11C>G does not alter protein length directly. Therefore, PM4 is not applied.

PM5

PM5 (Not Applied)

According to VCEP guidelines, PM5 applies to missense variants at residues with other pathogenic missense changes. c.97-11C>G is intronic. Therefore, PM5 is not applied.

PM6

PM6 (Not Applied)

According to standard ACMG/AMP guidelines, PM6 applies to assumed de novo occurrence without confirmation. No de novo data exist. Therefore, PM6 is not applied.

PP1

PP1 (Not Applied)

According to VCEP guidelines, PP1 requires cosegregation in multiple meioses. No segregation data are available. Therefore, PP1 is not applied.

PP2

PP2 (Not Applied)

According to standard ACMG/AMP guidelines, PP2 applies to missense variants in genes with low benign missense variation. This is intronic, not missense. Therefore, PP2 is not applied.

PP3

PP3 (Supporting)

According to VCEP guidelines, Intronic splice variants (excluding ±1,2) with SpliceAI ≥0.2 qualify for PP3 Supporting: "SpliceAI ≥ 0.2". The variant has a SpliceAI score of 0.97. Therefore, PP3 is applied at Supporting strength.

PP4

PP4 (Not Applied)

According to VCEP guidelines, PP4 requires phenotype specificity for TP53-related disorders. No phenotype data are provided. Therefore, PP4 is not applied.

PP5

PP5 (Not Applied)

According to VCEP guidelines, PP5 is not recommended for TP53 variant interpretation. Although ClinVar entries report pathogenicity, VCEP excludes PP5. Therefore, PP5 is not applied.

BA1

BA1 (Not Applied)

According to VCEP guidelines, BA1 Stand Alone applies for a filtering allele frequency ≥0.1%. The variant is absent. Therefore, BA1 is not applied.

BS1

BS1 (Not Applied)

According to VCEP guidelines, BS1 Strong applies for filtering allele frequency ≥0.0003. The variant is absent. Therefore, BS1 is not applied.

BS2

BS2 (Not Applied)

According to VCEP guidelines, BS2 requires observation in healthy older individuals. No such data exist. Therefore, BS2 is not applied.

BS3

BS3 (Not Applied)

According to VCEP guidelines, BS3 requires functional assay evidence of no loss of function. No functional data are available. Therefore, BS3 is not applied.

BS4

BS4 (Not Applied)

According to VCEP guidelines, BS4 requires lack of segregation in affected family members. No family data are available. Therefore, BS4 is not applied.

BP1

BP1 (Not Applied)

According to standard ACMG/AMP guidelines, BP1 applies to missense variants in genes where truncating variants cause disease. c.97-11C>G is intronic. Therefore, BP1 is not applied.

BP2

BP2 (Not Applied)

According to standard ACMG/AMP guidelines, BP2 applies to trans occurrences with a pathogenic variant. Not applicable. Therefore, BP2 is not applied.

BP3

BP3 (Not Applied)

According to standard ACMG/AMP guidelines, BP3 applies to in-frame repeats. Not applicable. Therefore, BP3 is not applied.

BP4

BP4 (Not Applied)

According to VCEP guidelines, BP4 applies when SpliceAI <0.2 for intronic variants. Here SpliceAI=0.97 predicts impact. Therefore, BP4 is not applied.

BP5

BP5 (Not Applied)

According to standard ACMG/AMP guidelines, BP5 applies if variant found in gene for an unrelated phenotype. Not applicable. Therefore, BP5 is not applied.

BP6

BP6 (Not Applied)

According to standard ACMG/AMP guidelines, BP6 applies to non-public reputable source reports of benign. VCEP does not use BP6. Therefore, BP6 is not applied.

BP7

BP7 (Not Applied)

According to VCEP guidelines, BP7 Supporting applies to intronic variants at ≥+7/≤−21 with SpliceAI ≤0.1. c.97-11C>G has SpliceAI=0.97. Therefore, BP7 is not applied.