PORTENT Clinical Network Capabilities
The PORTENT Center is enabled by a one-of-a-kind network of partner clinical sites in New York, Uganda, Ecuador, and India. This unique network of sites has been established over many years by the clinical team and can provide access to the diverse range of clinical populations, clinical and community expertise, and biobanks required to enable comprehensive validation of PoC devices for infectious diseases, cancer, and nutritional status. We have structured the core to be responsive to the needs of the center, allowing us to allocate funds and resources to sites where clinical support is best matched to the validation and training needs of the projects.
The Clinical Translation and Validation Core has four main goals:
- To enable human validation of PORTENT center and POCTRN network developed Point-of-Care (PoC) technologies by providing access to a wide array of sample biobanks and unique patient populations.
- To support the of validation studies conducted by the project teams.
- To work with the technology Development Core to identify new and existing PoC projects which can be transitioned to human/clinical validation.
- To work with the dissemination core to provide sites for clinical rotations and other learning experiences.
Our access to a diverse patient population in New York City and populations with nutritional deficiencies, cancers, and endemic tropical/infectious diseases at our Ecuador, India, and Uganda sites provides us with a range of opportunities to study promising PoC technologies. The US site will be led by Dr. Zhen Zhao who will lead the Point-of-Care technology clinical validation and translation at the Weill Cornell Medicine site. Our India site centered at the St. John’s Research Institute will be led by Professor Tony Raj and provides an innovation and incubation hub that will serve as our satellite technology development site. Further, there is an extensive biorepository of archived samples from multiple cohorts across the life span. Our Ecuadorian clinical site will be led by Professor Washington Cárdenas and centered at the Escuela Superior Politécnica del Litoral in Guayaquil and provide access to clinical settings and biorepository particularly focused on infectious diseases. Dr. Aggrey Semeere will lead the Uganda clinical at the Infectious Diseases Institute in Kampala, the site will provide access to several sites in east Africa with unique patient populations and specimens for cancer and infectious diseases. The table below summarizes some of the key features of these sites.
List of clinical sites and examples of resources available through PORTENT Clinical Network.
Location | Clincal Site Lead | Populations for Study (Available) | BioBank Samples (Available) | POC Projects by PORTENT (Current or Past) | POC Projects by PORTENT (Future) |
---|---|---|---|---|---|
New York City | Dr. Zhen Zhao | Demographically diverse population with health status ranging from healthy to those critically ill/ with sepsis at NewYork-Presbyterian/Weill Cornell Medical Center. Access to Clinical and Translational Science Center resources including its Metabolic Research Core | Established biobanks (e.g., HIV, critical illness, TB, cancer, pregnancy, COVID-19, Cardiac disease) and clinical specimens (e.g., whole blood, serum, plasma, urine, and CSF) | Rapid diagnostics for Cytomegalovirus infection and antibiotic resistance (PIs: Mehta, Erickson, Glesby, and Westblade) using the Clinical Microbiology biobank. Validation of assays for inflammatory biomarkers such as alpha-1 acid glycoprotein (AGP) | Validation of assays for inflammatory biomarkers such as alpha-1 acid glycoprotein (AGP) PoC for Cancer – DoD effort led by PDs funded this year to focus on screening for Prostate Cancer PoC solutions in surgery rooms |
Ecuador | Dr. Washington Cárdenas | Country with dual burden of infectious disease and noncommunicable diseases; similarly, high burden of both under- and over-nutrition; as well as diversity of socio-economic status Partner maternal and child, infection, and chronic disease hospitals will provide access to these populations | 5,643 total human samples in biobank from R01-funded FeverPhone and supplementary studies, including venous blood, stool, saliva, urine, and nasopharyngeal swabs (PIs – Erickson and Mehta) | NIH R01 supported work on PoC Diagnostics for acute febrile illness Validation of Nutritional assays such as those for Vitamin D | Diagnostics for cancers such as proposed by colleagues at MGH for Cervical Cancer Screening in year 1 of this proposal Screening and diagnostics for other neglected tropical diseases |
Uganda | Dr. Aggrey Semeere | Population suitable for PoC tests for nutritional biomarkers, HIV, Kaposi’s Sarcoma, Cervical Cancer, tuberculosis, malaria, STIs (Chlamydia, syphilis Gonorrhea), cryptococcal meningitis. | TB clinical Research Unit Biobank Clinical data and blood samples from a cohort of patients with HIV-infection 1600 human samples ongoing from cohort of patients with Kaposi’s Sarcoma including tissue blocks, slides, and venous blood. Endovaginal swabs and cervical biopsies ongoing from cohort of women with suspected cervical cancer | Validation study of PoC syphilis testing through the WHO’s TDR (Special Programme for Research Training in Tropical Diseases) | Field testing of PoC TB test using urine biomarkers in HIV/TB patients Validation of KS-Detect Kaposi’s Sarcoma PoC TINY system Other tests involving populations with HIV as well as cancers |
India | Dr. Tony Raj | Pregnancy, pediatric, and geriatric cohorts of > 10000 participants with samples banked from all trimesters and delivery (PI –Raj) CDC-funded Periconceptional cohort of ~2000 women of reproductive age from a rural area (PI – Finkelstein) Ongoing clinical surveillance of patients with TB and HIV | Samples from two child cohorts followed up for 9-12 months as part of two RCTs (Clinicaltrials.gov NCT02233764 and NCT02648893) (PI – Mehta) – including rectal swabs and stool samples Samples from the studies in the populations column that include blood, urine, saliva | NIBIB funded work on diagnostics for Anemia (PIs: Finkelstein, Erickson) NICHD funded work on determining appropriate biomarkers for nutrition and inflammation in alternate matrices such as saliva | PoC applications for maternal and child health, including those for improving healthy behaviors Pregnancy Infection Screening – Group B Streptococci and TORCH |