Reasoning
The VCEP requires a case-control study with p-value ≤.05 and either an odds ratio, hazard ratio, or relative risk ≥2, or a lower 95% CI ≥1.5. The directly verified Bernstein et al. study (PMID:16958054) reports 7/3,743 breast-cancer cases versus 0/1,268 controls for c.7271T>G, P=0.1. Treating the zero-control cell with the Haldane-Anscombe 0.5 correction, I computed OR=(7.5×1268.5)/(3736.5×0.5)=5.0923 and 95% CI 0.2906–89.2291; the reported p-value fails the VCEP p-value requirement and the CI includes 1. The directly verified Chenevix-Trench et al. study (PMID:11830610) reports one case and no controls, but provides no qualifying p-value or variant-specific case-control effect estimate. The directly verified Tavtigian et al. study (PMID:21787400) reports a variant-specific 8.0-fold risk estimate (95% CI 2.3–27.4; P=0.0005) for 15 carrier families, but this is family-based penetrance/segregation analysis rather than the VCEP-required case-control comparison. The literature packet also contains an AI-classified lead for PMID:27595995 reporting OR 11.0, but no source-registry entry or fetched full text was available to independently verify it, so it was not used as evidence.
VCEP rule
Case-control studies; p-value ≤.05 **and** (Odds ratio, hazard ratio, or relative risk ≥2 **or** lower 95% CI ≥1.5).
Evidence considered
- ClinGen HBOP ATM VCEP v1.6 PS4 rule: case-control studies require p-value ≤.05 and (odds ratio, hazard ratio, or relative risk ≥2 or lower 95% CI ≥1.5).
- Bernstein et al. 2006, PMID:16958054, abstract lines 19–24: 7/3,743 cases and 0/1,268 controls carried c.7271T4G; reported P=0.1 and HR=8.6 (95% CI 3.9–18.9) for cumulative-risk penetrance, not a qualifying case-control p-value/effect pair.
- From the PMID:16958054 counts, I computed the case-control OR with Haldane-Anscombe correction: OR=5.0923; 95% CI=0.2906–89.2291.
- Chenevix-Trench et al. 2002, PMID:11830610, abstract: one T7271G carrier among 525 case patients and none among 381 controls; no variant-specific p-value or qualifying case-control effect estimate was reported in the extracted evidence.
- Tavtigian et al. 2011, PMID:21787400, Results: 15 c.7271T>G carrier families had an 8.0-fold breast-cancer risk estimate (95% CI 2.3–27.4; P=0.0005), but this was family-based penetrance analysis, not the required case-control comparison.
- The literature-pass AI lead for PMID:27595995 states OR=11.0 for c.7271T>G, but the paper could not be independently verified from a source-registry-linked full text and was not used.
Still missing
- Independent verification of the PMID:27595995 variant-specific OR 11.0 lead is unavailable because that paper has no source_registry entry or fetched full text in this case.
Sources