Evaluating HPG80 for Diagnosing Neuroendocrine Tumors in MEN1 Patients
Official title: Study of the Value of hPG80 (Circulating Progastrin) for the Diagnosis of Neuroendocrine Tumours in Patients With an NEM1 Mutation: the Progastrin-NEM1 Study
Run by Centre Hospitalier Universitaire Dijon · NCT06430021 · Data updated 2026-11-12
This study is testing if a blood marker called HPG80 can help doctors diagnose neuroendocrine tumors in patients with a genetic condition called MEN1.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 297 (estimated) |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Status | Recruiting |
| Started | June 13, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT06430021 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with a confirmed MEN1 mutation, whether symptomatic or not, and who meet specific inclusion criteria related to MEN1 lesions.
✕Probably not a fit
Patients without an MEN1 mutation or those who do not meet the study's inclusion criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the value of HPG80, a circulating progastrin marker, in diagnosing neuroendocrine tumors (NETs) in patients with a confirmed MEN1 mutation. MEN1 is a hereditary condition characterized by multiple endocrine tumors, and the study will involve collecting blood samples from eligible patients to analyze the presence of HPG80. The goal is to improve diagnostic accuracy for NETs associated with MEN1, which can significantly impact patient management and outcomes.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic process for neuroendocrine tumors in patients with MEN1, leading to earlier detection and better treatment options.
How similar studies have gone: While this approach is novel in the context of MEN1 and HPG80, similar studies have shown promise in using biomarkers for diagnosing other types of tumors.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with proven MEN1, symptomatic or not, confirmed on the basis of the following international criteria (Thakker et al.): * patients with an MEN1 mutation; * patients belonging to an identified MEN1 family in which at least one first-degree relative has been affected and has at least one MEN1-related lesion; * patients without a positive genetic test or a family history of the disease, but with at least two of the three main MEN1 lesions (parathyroid adenomas, duodenopancreatic NETs and pituitary tumours). * Majors patients, * Patients who have undergone thoracoabdominal imaging (MRI, and/or CT and/or somatostatin receptor imaging (PET or octreotide scan)) within 3 months prior to inclusion or are due to undergo imaging within 3 months of inclusion to document the presence of NETs, * Regardless of the treatment they are receiving (treatment naïve or treated patient), * Regardless of the type of disease associated with MEN1 (presence or absence of NET, adenoma....), * Patients who did not object to taking part in the study. Exclusion Criteria: * Person not affiliated to national health insurance * Person subject to a measure legal protection (curatorship, guardianship, family empowerment) or a court order * Pregnant, parturient or breastfeeding mothers
Where it's running
-
Chu Dijon Bourgogne
Dijon, France Recruiting
Study contacts
- Study coordinator: Côme LEPAGE
- Email: come.lepage@chu-dijon.fr
- Phone: 0380293750
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.