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Suspended
NCT05926362
Capillary-Venous Paired Data Collection
Conditions: Oncology, Medical Devices, Healthy Subjects
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 800
Sponsor: Entia Ltd
Location: Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust Aylesbury Buckinghamshire
Summary
Capillary-venous paired data collection.
Eligibility Criteria
CANCER COHORT:
Subjects fulfilling all of the following inclusion criteria are eligible for the study:
* Age ≥18 years old at the time of study entry
* Currently receiving standard-of-care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy
* Scheduled to be undergoing routine venous laboratory blood tests as part of the standard of care
* Able to provide capillary whole blood donation from pricking three different fingers on one hand
* Can provide written informed consent
* In the Investigator's opinion, is able and willing to comply with all study requirements
The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:
* History or current diagnosis of haematological malignancy (including bone and lymph)
* Inadequate use and understanding of the English language, requiring a translator
HEALTHY COHORT
Subjects fulfilling all of the following inclusion criteria are eligible for the study:
* Age ≥18 years old at the time of study entry
* Can provide written informed consent
* Have an NHS number (to enable ordering and tracking of laboratory FBC tests)
* Registered with a GP
* In the Investigator's opinion, is able and willing to comply with all study requirements
The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:
* Inadequate use and understanding of the English language, requiring a translator
* Been hospitalised within 90 days prior to their study visit
* Donated whole blood or plasma to a blood bank within the 90 days prior to the study visit
* History of vasovagal syncope following blood draw
* History or current diagnosis of the following conditions:
* Cancer
* Cardiovascular disease
* Chronic kidney disease or end-stage renal disease
* Bleeding disorder (including but not limited to Immune Thrombocytopenia (ITP), hemophilia, von Willebrand disease (VWD))
* Blood clotting disorder (including but not limited to thrombophilia, antiphospholipid syndrome)
* G6PD deficiency
* Inflammatory bowel disease
* Myelodysplastic syndrome
* Ebola
* Tuberculosis
* HIV
* Hepatitis B or C
* Current diagnosis of Epstein-Barr Virus or Cytomegalovirus
* Current diagnosis of diabetes mellitus, unless controlled by diet alone OR participant has been taking the same dose of the same medication for 4 weeks or more and are feeling fit and well.
* Undergone organ transplantation
* Anemia, unless the participant is feeling fit and well (no dizziness, fatigue, shortness of breath etc)
Source: ClinicalTrials.gov (NCT05926362). StuddyBuddy aggregates publicly available trial information.