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NCT05041595
Lyme Disease Diagnostic Assay - Collection of Whole Blood
trial testing Lyme diagnostic assay in Lyme Disease in 450 participants. Status unknown.
30 December 2023
Quick facts
| Lead sponsor | DiaSorin Inc. |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 450 |
| Start date | 3 May 2021 |
| Primary completion | 30 December 2023 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lyme diagnostic assay
Conditions studied
- Lyme Disease — all drugs for Lyme Disease →
- Healthy — all drugs for Healthy →
Sponsor
DiaSorin Inc. — full company profile →
Who can join
Eligibility, any sex, with Lyme Disease or Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective is to obtain whole blood from subjects with signs and/or symptoms of early Borrelisois. Whole blood will also be obtained from subjects with suspicion of acute Borreliosis and under medical examination for Lyme disease. In addition, whole blood will be obtained from apparently healthy subjects residing in areas endemic to Lyme disease and may also inlclude apparently healthy subjects residing in areas non-endemic to Lyme disease.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
- PubMed search for NCT05041595
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other DiaSorin Inc. trials
Trials by the same sponsor.
- NCT07471490 — Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Dise · enrolling by invitation
- NCT05168917 — EURECA (EUropeanRElapseCAlprotectin) Study · NA · completed
- NCT03143517 — Fecal Calprotectin Collection Protocol · completed
- NCT03060746 — Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects · completed
- NCT03060733 — Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05041595 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by DiaSorin Inc.
- Last refreshed: 20 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05041595.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing