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Gene-disease assertions not curated here (add link or write note):

Disease

Heterotaxy with congenital heart defects

Inheritance

Autosomal dominant

Prevalence

 1 in 10,000

Source: https://medlineplus.gov/download/genetics/condition/heterotaxy-syndrome.pdf

Rapid or full curation?

  • Rapid
  • Full

ClinGen / GenCC / BabySeq / HGMD / OMIM

No ClinGen curations, no evidence for triplo/haplo sensitivity. GenCC strong for heterotaxy by PanelApp australia, Invitae and G2P.

Curated as Strong for congenital heart defects by BabySeq

Clinical Validity Scoring Notes and points

Citations from BabySeq:

  • Roessler 2008 PMID: 18538293 - Variants in CFC1 found in individuals with CHD shown in fig 3. there is author overlap with Bamford 2000, and there was a little more phenotype info in that paper..

    • c.522delC (Ala175Argfs*56) - extension variant but present in 0.1% of all chromosomes in gnomAD… seems too frequent.

    • F162L is also present in 2% of African/African American chromosomes by gnomAD. Do not score.

    • c.650C>G P217R is present in >2% of AA gnomAD chr, did not score

    • c.362+2T>C - (ie IVS4+2T>C) absent from gnomAD. Reported in 4 individuals - one with TOF, but also had variants in FOXh1 per the caption. Also reported in someone with TA, TOF, and AVC.

    • 433G>A Ala145Thr - >4% overall gnomAD frequency, did not score.

    • 232C>T p.R78W - absent gnoad, observed in individaul with TOF, TGA and CHD.

    • c.-7A>G - absent gnomAD observed in individual with TOF and one with AVC.

    • c.23+6G>C aka IVS1+6G>C absent gnomAd found in individual with AVC

    • E210K is in 5 alleles in gnomAD, not very high frequency in an individual with c.650C>G

  • Bamford 2000 PMID: 11062482 - LOF variants in patients with heterotaxic phenotypes. Same authors as PMID: 18538293. However, the phenotypic info seems richer here.

    • 334C>T R112C - absent gnomAD found in individual with midline and laterality defects: complex cardiac anomalies, intestinal malrotation, additional features absent corpus callosum, microcephaly. Fig 2 shows abnormal clustering at the cell surface, but to be honest I don’t really see it in the figure. Variant was unable to rescue MZoep zebrafish phenotype. 0.5 POINT + 0.5 FUNCTIONAL = 1 POINT

    • c.552delC - I think this is a typo… prior paper has the variant as 522delC and this variant has high MAF.

    • R189C als reported with different c. nomenclature (per HGMD this variant is 565C>T. Present in 2 alleles in gnomAD. Found in patient with CCA iwth L atrial isomerism, VSD, polysplenia. Variant was able to rescue the mZoep zebrafish phenotype (similar to WT). 0.5 POINT

    • 232C>T p.R78W in Individuals 5-9. Per main text, found in 5 unrelated sporadic patients of African Amercan descent. They all had complex heart defects. Patient 5 with CCA, dextrocardia, DORV, PA, complete AV canal, R78W TAPVR, PDA, R-sided aortic arch, R-isomerism of lungs, intestinal malrotation, asplenia. Patient 6 with HLHS, L-atrial isomerism, dysplasia of mitral valve & L ventricular outflow tract, R-isomerism of lungs, R-sided stomach, extrahepatic biliary atresia, polysplenia. Patient 7 with dextrocardia, TGA, common atrium, VSD, PA. Patient 8 with dextrocardia, ASD, VSD, PDA hypoplastic aortic arch, central liver, omphalocele, abnormal ribs. Patient 9 with membranous VSD and holoprosencephaly. Fig 2 shows abnormal clustering at the cell surface, but to be honest I don’t really see it in the figure. Variant was able to rescue the mZoep zebrafish phenotype (similar to WT). R78W VARIANT REPORTED IN 5 INDIVIDUALS - 5x0.5 = 2.5 POINT but downgrading due to lack of evidence from zebrafish phenotype. 2 POINT

  • Wang 2011 19853937 - c. G506T p. Gly169Val; c. G517A p. Gly173Arg; c. G658T p. Leu219Phe - variants found in individuals with ASD or VSD… going to skip reviewing further for now since these phenotypes are very common.

  • Goldmuntz 2002 PMID: 11799476 - reports c.552delC which is present at a high gnomAD frequency. Also reports c.361_362+18dupAGGTGGGCACAGGGGTGCGC (absent gnomAD) in an individual with D-TGA and pyloric stenosis. Unclear what the exact effect of this duplication would be, could potentially create a cryptic donor site but the native site is intact. 0.5 VARIANT POINT

  • Cemil Ozcelik 2006 PMID: 17072672 - did not review further; phenotypes were ASDs, too common to score and authors note that gene appears to be infrequent cause of CHD without laterality defects.

  • Gonzales 2020 PMID: 31633655 - c.248G>T; p.(Gly83Val) absent gnomad found in a parent and proband with situs inversus. No structural heart defects noted. 0.5 VARIANT POINT

  • PMID: 17445335 -3 non-synonymous coding variants (c.61A>C N21H, R47Q, and R78W), and 2 intronic variants in CFC1. c.61A>C N21H and c.140G>A N21H are too frequent, both present in 1.7% of total gnomAD chromosomes. R78W is absent gnomADwas found in 2 patients: patient 23 with Left inferior caval vein, double outlet right ventricle, atrioventricular A septal defect, pulmonary stenosis, totally anomalous pulmonary venous return, transverse liver, right sided stomach, asplenia. Patient 42 with Inferior caval vein to base of common atrium, bilateral superior caval H vein, right ventricle dominant atrioventricular septal defect, pulmonary atresia, bilaterally symmetrical pulmonary venous return. RECURRENT VARIANT, SCORED ABOVE

  • PMID: 10574770 - homozygous mouse knockout shows laterality defects and majority died during the first week of life because of complex cardiac malformations such as malpositioning of the great arteries, and atrial–ventricular septal defects. However, doesn’t match with the human reports of het / dominant variants.

  • PMID: 10521397 - another mouse model, homozygous KOs show laterality defects including heterotaxia, randomization of organ situs, and isomerism of bilaterally asymmetric tissues. ,zebrafish one-eyed pinhead(oep) mutants that have beenrescued partially by mRNA injection display heterotaxia, including randomization of heart looping and pancreas location. So some evidence of heterotaxy but still inconsistent with the inheritance in humans.

2 ADDITIONAL VARIANTS (DUPLICATIONS) IN HGMD, but gene was clinGen curated as no evidence for triplosensitivity.

Clinical Validity Points Total

4.5 POINTS

Source:

Clinical Validity Classification

 Classifications (pts)

Definitive (12pts)

Strong (12pts)

Moderate (7-11pts)

Limited (0.1-6pts)

No genetic evidence

Refuted

Disputed

LIMITED

Source:

Molecular Mechanism

 Mechanisms

Loss of function

Gain of function

Dominant negative

Unknown

Other

Loss of function / Gain of function / Dominant Negative

Penetrance

 options

Complete (100%)

High (≥80%)

Moderate  (<80% and >20%)

Low (≤20%)

(list source/PMID)

Source:

Age of Onset

 options

Congenital

Pediatric

Adolescent

Adulthood

Late adulthood

(list source/PMID)

Severity

 Options

Embryonic lethal - presence of a pathogenic variant or variants is not compatible with life. The penetrance must be complete.
Severe - presence of a pathogenic variant or variant(s) results in significantly reduced fitness. The penetrance must be complete or high.
Moderate - significant morbidity or mortality due to clinical features, but fitness may not be reduced, or penetrance is reduced.
Mild - Presence of a variant or variant(s) is not associated with reduced fitness, no significant morbidity or mortality, and/or penetrance is low.
None - presence of a variant results in no phenotype. An example is recessive disorders in which no phenotype is reported in carriers.

Clinical Features

Sources:

HPO Terms

https://hpo.jax.org/app/

Gene SOPs & Notes

 LINK if SOP is a long document. Short notes if it is easy to digest. eg. Last known truncating variant

Curation Summary

 Examples

- The @GENE@ is associated with @inheritance pattern@ @condition@, which is characterized by @clinical features@ (PMIDs).

- Variable expression or severity:
The severity and expressivity of the disorder is highly variable, even within families.
- If multiple conditions associated with the gene:
It has also been associated with @inheritance pattern@ @condition@, which is characterized by @clinical features@ (PMIDs).

- Limited evidence gene: The PCNA gene has been reported in individuals with early onset autosomal recessive ataxia (PMID: 33426167, 24911150), however, evidence supporting this gene-dIsease relationship is limited

Case ID, Curator name, Date, Jira ticket link

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