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Researching COVID to enhance recovery (RECOVER) tissue pathology study protocol: Rationale, objectives, and design

Troxel, Andrea B; Bind, Marie-Abele C; Flotte, Thomas J; Cordon-Cardo, Carlos; Decker, Lauren A; Finn, Aloke V; Padera, Robert F; Reichard, R Ross; Stone, James R; Adolphi, Natalie L; Casimero, Faye Victoria C; Crary, John F; Elifritz, Jamie; Faustin, Arline; Ghosh, Saikat Kumar B; Krausert, Amanda; Martinez-Lage, Maria; Melamed, Jonathan; Mitchell, Roger A; Sampson, Barbara A; Seifert, Alan C; Simsir, Aylin; Adams, Cheryle; Haasnoot, Stephanie; Hafner, Stephanie; Siciliano, Michelle A; Vallejos, Brittany B; Del Boccio, Phoebe; Lamendola-Essel, Michelle F; Young, Chloe E; Kewlani, Deepshikha; Akinbo, Precious A; Parent, Brendan; Chung, Alicia; Cato, Teresa C; Mudumbi, Praveen C; Esquenazi-Karonika, Shari; Wood, Marion J; Chan, James; Monteiro, Jonathan; Shinnick, Daniel J; Thaweethai, Tanayott; Nguyen, Amber N; Fitzgerald, Megan L; Perlowski, Alice A; Stiles, Lauren E; Paskett, Moira L; Katz, Stuart D; Foulkes, Andrea S; ,
IMPORTANCE/OBJECTIVE:SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or organ dysfunction after the acute phase of infection, termed Post-Acute Sequelae of SARS-CoV-2 (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are poorly understood. The objectives of the Researching COVID to Enhance Recovery (RECOVER) tissue pathology study (RECOVER-Pathology) are to: (1) characterize prevalence and types of organ injury/disease and pathology occurring with PASC; (2) characterize the association of pathologic findings with clinical and other characteristics; (3) define the pathophysiology and mechanisms of PASC, and possible mediation via viral persistence; and (4) establish a post-mortem tissue biobank and post-mortem brain imaging biorepository. METHODS:RECOVER-Pathology is a cross-sectional study of decedents dying at least 15 days following initial SARS-CoV-2 infection. Eligible decedents must meet WHO criteria for suspected, probable, or confirmed infection and must be aged 18 years or more at the time of death. Enrollment occurs at 7 sites in four U.S. states and Washington, DC. Comprehensive autopsies are conducted according to a standardized protocol within 24 hours of death; tissue samples are sent to the PASC Biorepository for later analyses. Data on clinical history are collected from the medical records and/or next of kin. The primary study outcomes include an array of pathologic features organized by organ system. Causal inference methods will be employed to investigate associations between risk factors and pathologic outcomes. DISCUSSION/CONCLUSIONS:RECOVER-Pathology is the largest autopsy study addressing PASC among US adults. Results of this study are intended to elucidate mechanisms of organ injury and disease and enhance our understanding of the pathophysiology of PASC.
PMCID:10781091
PMID: 38198481
ISSN: 1932-6203
CID: 5628642

HPV Cotesting of Unsatisfactory Papanicolaou Tests: Implications for Follow-up Intervals

Chen, Fei; Hsu Lin, Lawrence; Hindi, Issa; Sun, Wei; Shafizadeh, Negin; Szeto, Oliver; Brandler, Tamar C; Simsir, Aylin
OBJECTIVES/OBJECTIVE:The 2019 American Society of Colposcopy and Cervical Pathology management guidelines recommend that patients with an unsatisfactory Papanicolaou (Pap) test (UPT) and negative human papillomavirus (HPV) cotest undergo repeat age-based screening in 2 to 4 months. The rationale is that a negative HPV test in the setting of an UPT may reflect an inadequate sample and therefore should not be interpreted as truly "negative." For patients 25 years and older who are cotested, if HPV is positive for the 16 or 18 genotypes, direct referral for colposcopy is recommended. Our study aimed to determine if a negative HPV cotest result is predictive of the absence of a high-grade squamous intraepithelial lesion (HSIL) and whether these patients may be called back for repeat testing at an interval longer than 2 to 4 months. METHODS:Follow-up cervical cytology and biopsy results in women with UPT and HPV cotests from January 2017 to December 2021 were collected. Original UPT and HPV cotest results were correlated with the follow-up Pap and biopsy results. RESULTS:There were 1,496 (2.28%) UPT cases out of 65,641 total Pap tests. Among the 1,496 UPT cases, 1,010 (67.5%) had HPV cotesting; 676 (45.1%) were followed by repeat Pap or biopsy within 4 months and 850 (56.8%) within 12 months. The total follow-up rate was 81%, with a range of 3 days to 36 months. The HSIL rate in HPV-positive cases was 5.7% (3/53) vs 0.4% (2/539) (P = .006) in HPV-negative cases. In UPT, HPV cotesting showed negative predictive values for low-grade and high-grade squamous intraepithelial lesion detection of 98.5% and 99.6%, respectively, while positive predictive values were 19% and 5.7%. CONCLUSIONS:A negative HPV cotest in individuals with UPT predicted the lack of HSIL in our study. Compliance with the recommended follow-up time of 2 to 4 months for women with UPT was low (45.1%). Our study suggests that women with UPT and negative HPV cotest may be safely called back at an interval longer than 4 months.
PMID: 37052613
ISSN: 1943-7722
CID: 5479502

Reasearching COVID to enhance recorvery (RECOVER) autopsy tissue pathology study protocol: Rationale, objectives, and design [PrePrint]

Troxel, Andrea B; Bind, Marie-Abele C; Flotte, Thomas J; Cordon-Cardo, Carlos; Decker, Lauren A; Finn, Aloke V; Padera, Robert F; Reichard, R. Ross; Stone, James R; Adolphi, Natalie L; Casimero, Faye; Crary, John F; Elifritz, Jamie; Faustin, Arline; Kumar B Ghosh, Saikat; Krausert, Amanda; Martinez-Lage, Maria; Melamed, Jonathan; Mitchell Jr, Roger A; Sampson, Barbara A; Seifert, Alan C; Simsir, Aylin; Adams, Cheryle; Haasnoot, Stephanie; Hafner, Stephanie; Siciliano, Michelle A; Vallejos, Britanny B; Del Boccio, Pheobe; Lamendola-Essel; Michelle F; Young, Chloe E; Kewlani, Deepshikha; Akinbo, Precious A; Parent, Brendan; Chung, Alicia; Cato, Teresa C; Mudumbi, Praveen; Esquenazi-Karonika, Shari; Wood, Marion J; Chan, James; Monteiro, Jonathan; Shinnick, Daniel J; Thaweethai, Tanayott; Nguyen, Amber N; Fitzgerald, Megan L; Perlowski, Alice A; Stiles, Lauren E; Paskett, Moira L, Katz, Stuart D; Foulkes, Andrea S
ORIGINAL:0017086
ISSN: n/a
CID: 5573572

Genomic Profiling of Metastatic Tumors in Pleural Effusion Specimens: Comparison of Fresh Supernatant, Fresh Cell Pellet, and Cell Block Material for Testing [Meeting Abstract]

Chen, Fei; Belovarac, Brendan; Shen, Guomiao; Feng, Xiaojun; Brandler, Tamar; Jour, George; Sun, Wei; Snuderl, Matija; Park, Kyung; Simsir, Aylin
ISI:000990969800303
ISSN: 0023-6837
CID: 5525432

Utility of Urine Cytology Specimens for Molecular Profiling in Detection of High-Grade Urothelial Carcinoma [Meeting Abstract]

Chen, Fei; Belovarac, Brendan; Shen, Guomiao; Feng, Xiaojun; Jour, George; Sun, Wei; Snuderl, Matija; Simsir, Aylin; Park, Kyung
ISI:000990969800304
ISSN: 0023-6837
CID: 5525442

Salivary Gland Neoplasm of Uncertain Malignant Potential (SUMP) (Milan IVB) and its Subgroups: Analysis of Risk of Neoplasm and Malignancy [Meeting Abstract]

Hindi, Issa; Brandler, Tamar; Belovarac, Brendan; Szeto, Oliver; Hernandez, Osvaldo; Sun, Wei; Liu, Cheng; Zhou, Fang; Simsir, Aylin
ISI:000990969800333
ISSN: 0023-6837
CID: 5525452

DICER1 Mutation in Bethesda III Thyroid Nodules [Meeting Abstract]

Karimkhan, Afreen; Xia, Rong; Hindi, Issa; Belovarac, Brendan; Shafizadeh, Negin; Sun, Wei; Patel, Kepal; Givi, Babak; Hodak, Steven; Simsir, Aylin; Brandler, Tamar
ISI:000990969800344
ISSN: 0023-6837
CID: 5525462

Defining Quality Metrics in Thyroid FNA Cytology: A Comparison of Cytopathologists' TBS III, Molecular Positivity and TBS III:VI Rates in a Large Academic Institution [Meeting Abstract]

Brandler, Tamar; Xia, Rong; Shafizadeh, Negin; Hindi, Issa; Belovarac, Brendan; Karimkhan, Afreen; Sun, Wei; Simsir, Aylin
ISI:000990969803397
ISSN: 0023-6837
CID: 5525472

Liver fluke eggs in bile duct brush cytology: An unexpected diagnosis during evaluation of a biliary stricture

Chen, Fei; Aguero-Rosenfeld, Maria; Simsir, Aylin; Brandler, Tamar C
Clonorchis sinensis, a liver fluke parasite, infects humans through ingestion of raw or undercooked fish, crabs, or crayfish in endemic areas where the parasite is found. Clonorchis sinensis infects the liver, gallbladder, and bile duct in humans, causing Clonorichiasis. Although the majority of patients are asymptomatic, long-lasting infections may cause severe disease. Without treatment, human infection may persist for the parasite's lifespan (25-30 years). Pathologic diagnosis can be challenging as sampling may demonstrate limited cellularity with minuscule eggs that may be overlooked. Here, we report a rare case of liver fluke eggs diagnosed in bile duct brush cytology.
PMID: 35984297
ISSN: 1097-0339
CID: 5300282

Cytomorphology of Low-Grade Urothelial Neoplasia (LGUN) in Urine Cytology [Meeting Abstract]

Xia, R; Sun, W; Chen, F; Lin, L; Shafizadeh, N; Shi, Y; Deng, F -M; Simsir, A; Brandler, T
Introduction: The utility of The Paris System (TPS) in diagnosing low-grade urothelial neoplasm (LGUN) on urine cytology is controversial due to the strict requirement for fibrovascular cores, and low sensitivity/specificity. Many LGUNs are classified as atypical urothelial cells (AUC) on cytology, which compromises the performance and utility of TPS. Here, we studied cytomorphologic features of LGUN in urine samples to determine which features were commonly observed.
Material(s) and Method(s): Twenty-two urine cytology cases with corresponding (within 2 months) LGUN histologic diagnosis were retrieved for this pilot study and were evaluated by one cytopathologist for the presence of clusters, cercariform cells, hyperchromasia, irregular nuclear rim, papillary architecture +/-fibrovascular core, and nucleus:cytoplasm (N:C) ratio (Figure 1). Hierarchical cluster analysis (Ward's Method) was used to classify the features.
Result(s): Of the 22 urines, one was voided (4.5%) and 21 were instrumented (95.5%). Majority (77.3%) were diagnosed as AUC, 1 was suspicious for urothelial carcinoma (4.5%), 4 cases were graded as LGUN (18.2%, Table 1). Clustering analysis demonstrated that the morphologic features abundantly present in the urine specimen of LGUN included: clusters (77.3%), N:C ratio >50% (85.4%), and papillary architecture without a core (72.7%). The features that were mostly absent in LGUN specimens included: irregular nuclear rim (0%), papillary formation with a core (0%), hyperchromasia (9.1%), coarse chromatin (22.7%), and cercariform cells (36.3%). (Table 2).
Conclusion(s): Papillary formation with a fibrovascular core, the most convincing feature of LGUN, was not present in our pilot cohort of LGUN urines. However, our study describes additional cytomorphologic features that may be useful in identifying LGUN in urine cytology. Our research will continue with the evaluation of a larger cohort of LGUN cases with corresponding urine cytology in order to further investigate these findings
EMBASE:640494478
ISSN: 1938-2650
CID: 5512122