Search for a trial

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,…

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.

T-Cell Mediated Plaque Inflammation and Atherosclerosis in Stage III Melanoma Patients on (neo-)adjuvant Immune Checkpoint Inhibitors: a prospective matched cohort study

To investigate the effects of ICIs (anti-CTLA4, anti-PD1, combination anti-CTLA4/PD1) on vascular inflammation (PET-CT) in stage III melanoma patients. We hypothesize that the increase in vascular inflammation will be greater in the exposure group…

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…

Personalized elective neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (chemo)radiotherapy to the PRIMary tumor Only. The PRIMO study.

To compare safety and efficacy of treatment with sentinel lymph node biopsy guided elective neck irradiation versus standard elective neck irradiation in patients receiving definitive (chemo)radiotherapy for squamous cell carcinoma of the…

An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples from adult participants with metastatic Non-Small Cell Lung Cancer (NSCLC) for potential inclusion in the MSD Phase 3 clinical trial (Protocol No MK-1084-004) to demonstrate clinical performance of the therascreen® KRAS RGQ PCR Kit.

To utilize the therascreen KRAS RGQ PCR Kit (KRAS Kit) as a screening test to identify KRAS G12C mutations in newly diagnosed metastatic NSCLC participants and thereby determine eligibility for enrolment into the Phase 3 clinical study (MK-1084-004…

The beneficial value of 18F FDG PET/CT in the follow-up of stage III non-small cell lung cancer patients

Primary Objective The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT surveillance. Secondary…

A prospective, randomized study comparing chemotherapy versus chemotherapy plus immunotherapy in patients with advanced non-small cell lung cancer with low TMB and oncogenic driver, STK11, KEAP1 or NFE2L2 mutation and a PD-L1 TPS

To compare the objective response rate between patients with metastatic non-small cell lung cancer characterized by PDL-1 TPS<50% and low TMB and either actionable mutation, inactivating STK11, KEAP1 or NFE2L2 mutations, treated by…

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)

Primary Objectives:Associated pharmaceutical trial:To compare the efficacy of disitamab vedotin in combination with pembrolizumab to chemotherapy as first-line treatment in participants with advanced UC that expresses HER2Clinical…

Clinical outcomes and cost-effectiveness of a diagnostic and treatment strategy of upfront CTCA plus selective non-invasive functional imaging compared with standard care in patients with chest pain and suspected coronary artery disease

This strategy will result in a reduction reduce the incidence of major adverse cardiovascular events (MACE) defined as death or non-fatal myocardial infarction and appear more efficient than care as usual.

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…

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]. …

Clinical Performance Study Plan (CPSP) for the use of GenDx CDx Tedopi for subject enrollment on to the OSE Immunotherapeutics Phase 3 trial (OSE2101C302) of OSE2101 versus docetaxel in HLA-A*02 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to immune checkpoint inhibitor (ARTEMIA)

This clinical performance study/clinical investigation will evaluate the safety and effectiveness of GenDx CDx Tedopi in identifying HLA-A*02 status in metastatic NSCLC subjects who may be eligible for treatment with OSE2101.

PSMA Detect

The primary objective of this study is to evaluate the added value of PSMA PET/CT and PSMA-targeted biopsies of PSMA-avid lesions in detecting ISUP GG ≥ 2 prostate cancer in patients with a negative or equivocal MRI (PIRADS 1-3) and a PSA density…