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NCT04843397: PROSPERO

Diagnostic Performance Indicators in Upper GI Endoscopy:PROSPERO Study

Status unknown Last updated 15 April 2021
What this trial tests

trial in Esophageal Cancer in 1,000 participants. Status unknown.

Timeline
1 June 2021
Primary endpoint
1 June 2022
15 September 2022

Quick facts

Lead sponsorUniversity of Cambridge
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,000
Start date1 June 2021
Primary completion1 June 2022
Estimated completion15 September 2022

Conditions studied

Sponsor

University of Cambridge

Who can join

18 and older, any sex, with Esophageal Cancer or Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cancers of the upper gastro-intestinal tract, including esophagus (gullet), stomach and small bowel, are amongst the deadliest malignancies. The main reason for their high mortality rate is that they are usually diagnosed late when curative treatments are no longer effective. However, these types of cancer generally arise from well-described pre-cancerous diseases, such as Barrett's esophagus and gastric intestinal metaplasia. This provides an opportunity for clinicians to detect these pre-cancerous conditions early and offer adequate cure or clinical monitoring before they progress to cancer. A camera test (gastroscopy) is the gold-standard test to detect pre-cancerous diseases in these organs. There has been limited research to set the standards for performance of a gastroscopy, especially with regards to diagnosis of pre-cancerous conditions, which require knowledge and skills by the physician performing the test (endoscopist). Therefore, the hypothesis behind this study is that the aforementioned pre-cancerous diseases are understudied and often go undetected. This study aims to understand how often endoscopists should diagnose these pre-cancerous diseases on routine gastroscopy and help define the standards to measure performance. The investigators will assess the following rates: i. how often endoscopists diagnose these pre-cancerous lesions during endoscopy; ii. How often these conditions are diagnosed on biopsies taken according to a standardized protocol; iii. How often these condition should have been diagnosed by the endoscopists based on the review of pictures by expert endoscopists. The investigators will also compare the rates of correct diagnosis by endoscopists with different levels of experience and based on the times spent to complete the diagnostic test. Investigating these aspects will enhance the understanding of the medical community with regards to the diagnosis of these pre-cancerous lesions and set endoscopy standards to improve their early detection and treatment before they progress to cancer. This will translate to improved cancer prevention and benefit for patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. UEG Week 2024 Oral Presentations
    · 2024

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Other recruiting trials for Esophageal Cancer

Currently open trials in the same condition.

Other University of Cambridge trials

Trials by the same sponsor.

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Data sources for this page

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/NCT04843397.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing