Development and validation of a diagnostic prediction model for pancreatic ductal adenocarcinoma: VAPOR 1, protocol for a prospective multicentre case-control study.

Walsh, CM ORCID: 0000-0002-2257-9063, Murray, J ORCID: 0000-0002-6494-4815, Laponogov, I ORCID: 0009-0002-3033-2930, Parker, A ORCID: 0000-0003-4289-8683, Ellis, JK ORCID: 0000-0001-7553-4486, Converso, V, Austin, E ORCID: 0000-0003-2817-5534, Boshier, PR ORCID: 0000-0003-4549-3745, Czajkowski, C, Spalding, D, Al-Mukhtar, A, Frampton, AE, Roberts, KJ, Pandanaboyana, S, Halloran, C ORCID: 0000-0002-5471-4178, Costello, E ORCID: 0000-0002-0104-8992, Kocher, H ORCID: 0000-0001-6771-1905, Mitra, V, Hamady, Z, Al-Sarireh, B et al (2025) Development and validation of a diagnostic prediction model for pancreatic ductal adenocarcinoma: VAPOR 1, protocol for a prospective multicentre case-control study. BMJ open, 15 (8). ISSN 2044-6055

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Abstract

Introduction Pancreatic ductal adenocarcinoma (PDAC) continues to have extremely poor patient outcomes, unlike other cancer types which have seen significant improvements in their treatments and survival. A major contributing factor is that PDAC is often detected at an advanced, incurable stage. In the UK, nearly half of patients have stage 4 disease at the time of diagnosis, which has a profound effect on treatment options and, ultimately, survival. To address the challenge of early detection of PDAC, this study aims to develop and validate a clinical prediction model based on a non-invasive breath test. The proposed breath test aims to assist general practitioners in the triaging of patients who present with symptoms that do not meet current criteria for urgent suspected PDAC pathway referral.

Methods and analysis The Volatile organic compound Assessment in Pancreatic ductal adenOcaRcinoma (VAPOR 1) study is a prospective, multicentre, case–control study that aims to recruit 771 participants from England, Wales and Scotland. These include adult participants, aged ≥18 years, in three cohorts: pancreatic ductal adenocarcinoma; benign pancreatic controls (chronic pancreatitis or new-onset diabetes); healthy controls with a normal pancreas on imaging. A one-off breath sample will be obtained from participants who have fasted for at least 6 hours, and participant demographics and clinical data will be recorded. Breath samples will be analysed using gas chromatography–mass spectrometry to identify the volatile organic compounds (VOCs) present. Relationships between VOCs of interest and the presence of PDAC will be explored, and a clinical prediction model will be developed using statistical and machine learning methods and internally validated.

Ethics and dissemination The VAPOR 1 study has received approval from the South East Scotland Research Ethics Committee 02, and from the Health Research Authority and Health and Care Research Wales (REC 22/SS/0061). Results of this study will be published in open-access peer-reviewed journals, and disseminated through pancreatic cancer conference presentations. In addition, lay summaries shared on our website, social media platforms and through our charitable funder, Pancreatic Cancer UK, will enable engagement with patients and the wider public.

Item Type:	Article
Uncontrolled Keywords:	VAPOR Collaborators; Humans; Carcinoma, Pancreatic Ductal; Pancreatic Neoplasms; Breath Tests; Case-Control Studies; Prospective Studies; Adult; Female; Male; Multicenter Studies as Topic; Early Detection of Cancer; Volatile Organic Compounds; United Kingdom; Case-Control Studies; Clinical Decision-Making; Gastrointestinal tumours; Pancreatic disease; Pancreatic surgery; Triage; Humans; Carcinoma, Pancreatic Ductal; Pancreatic Neoplasms; Case-Control Studies; Prospective Studies; Volatile Organic Compounds; Breath Tests; Multicenter Studies as Topic; Early Detection of Cancer; Female; Adult; Male; United Kingdom; 32 Biomedical and Clinical Sciences; 3202 Clinical Sciences; 42 Health Sciences; Digestive Diseases; Pancreatic Cancer; Rare Diseases; Clinical Research; Cancer; Machine Learning and Artificial Intelligence; Prevention; 4.1 Discovery and preclinical testing of markers and technologies; 4.2 Evaluation of markers and technologies; Cancer; 3 Good Health and Well Being; Humans; Carcinoma, Pancreatic Ductal; Pancreatic Neoplasms; Case-Control Studies; Prospective Studies; Volatile Organic Compounds; Breath Tests; Multicenter Studies as Topic; Early Detection of Cancer; Female; Adult; Male; United Kingdom; 1103 Clinical Sciences; 1117 Public Health and Health Services; 1199 Other Medical and Health Sciences; 32 Biomedical and clinical sciences; 42 Health sciences; 52 Psychology
Subjects:	R Medicine > RA Public aspects of medicine R Medicine > RC Internal medicine > RC1200 Sports Medicine
Divisions:	Sport and Exercise Sciences
Publisher:	BMJ
Date of acceptance:	4 August 2025
Date of first compliant Open Access:	16 April 2026
Date Deposited:	16 Apr 2026 09:00
Last Modified:	16 Apr 2026 09:00
DOI or ID number:	10.1136/bmjopen-2024-094505
URI:	https://researchonline.ljmu.ac.uk/id/eprint/28390

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