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Clinical performance study protocol for use of the B7-H4 (A57.1) Assay to identify and select B7-H4 positive ovarian, endometrial, biliary tract, breast cancer, and squamous non-small cell lung cancer patients for recruitment into the AstraZeneca Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Tumors

The primary objective of this clinical performance study is to evaluate the effectiveness of the B7-H4 (A57.1) Assay in identifying B7-H4 positive (B7-H4 membrane staining at any intensity in ≥25% tumor cells) ovarian, endometrial, biliary tract,…

Tina-quant Lp(a) RxDx Phase III Trial Sample Measurement

The objective of this study is to support the pharma partner*s Phase III trial using Tina-quant Lipoprotein (a) RxDx assay for subject selection and optional batch testing of follow-up samples. This study is carried out to evaluate the performance…

Basophil Activation Test cow's milk for replacement of the food challenge test

Determination of the (cost)effectiveness of the replacement of the expensive, risky and time-consuming food challenge test bythe Basophil Activation Test (BAT) for the diagnosis of an IgE-mediated cow*s milk allergy in children.

Clinical Performance Study Protocol for Use of VENTANA PD-L1 (SP263)
CDx Assay in [redacted]

The objective of this study is to establish the clinical performance of VENTANA PD-L1 (SP263) CDx Assay as a companion diagnostic (CDx) for the identification of patients with NSCLC who may benefit from treatment with [redacted]. …

An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples in a first line setting from patients diagnosed with metastatic Colorectal Cancer (mCRC) to determine the KRAS G12C mutation status as part of the inclusion criteria into the Amgen Phase III clinical trial (Protocol No 20210081) to demonstrate clinical performance of the therascreen® KRAS RGQ PCR Kit.

To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen*s Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of…

Standardized dietary challenge to monitor effects of rehabilitation program in patients with COPD: a pilot study

In the present pilot study, we intend to test phenotypic flexibility (Phenflex)  in 20 clinically stable patients with COPD by exploring their response to a dietary challenge test before and after pulmonary rehabilitation. Moreover, the…

Measuring effects of high-fiber dried chicory root on the gut microbiota of patients with an intermediate to high-risk cutaneous melanoma: an explorative study

The primary objective of this study is to investigate the effect of dried chicory root (WholeFiber) during 6 weeks on fecal SCFA levels in intermediate to high-risk melanoma patients after surgical treatment with no concurrent adjuvant treatment.…

Dietary protein provides building blocks for all human tissues: the metabolic fate of milk protein
an explorative proof-of-principle study

The main aim of the current study will be to determine the metabolic fate of dietary protein. More specifically, the main aim is to assess the incorporation of protein-derived amino acids in a wide variety of organ tissues in vivo in humans.

Re-evaluation of the muscle-full effect during continuously elevated amino acid availability in healthy young males

To assess muscle protein synthesis rates to continuous, elevated plasma amino acid availability in healthy young males

Presepsin pilot study

The objective of this pilot study is to assess whether transportation of the sample via a pneumatic tube system (PTS) has any detrimental effects on the recovery of presepsin levels, when compared to traditional hand-delivery. This research will be…

Forearm immobilization in T2D (FIT2D)

To assess the impact of short-term forearm immobilization on forearm muscle glucose uptake and amino acid net balance and kinetics of individuals with T2D compared with a control group with normoglycaemia.

Amino acids in the blood after intake of high-protein dairy products

The objective of this study is to determine the EAA bioavailability in the blood circulation after ingestion of three high-protein dairy products, that differ in their AA composition 

In Vitro Diagnostic Clinical Performance Study Plan to determine HER2 and PD-L1 status of HER2-positive gastric cancer specimens.

Supplement to Clinical Study Protocol: D702AC00001 (Artemide-Gastric01)

To support the AstraZeneca ARTEMIDE-Gastric01 clinical trial by testing for PD-L1 and HER2 expression in FFPE tumor specimens for eligibility and stratification.The primary objective of this clinical performance study is to evaluate the…