Evaluating HPG80 for Diagnosing Neuroendocrine Tumors in MEN1 Patients
Study of the Value of hPG80 (Circulating Progastrin) for the Diagnosis of Neuroendocrine Tumours in Patients With an NEM1 Mutation: the Progastrin-NEM1 Study
Centre Hospitalier Universitaire Dijon · NCT06430021
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 |
|---|---|
| Enrollment | 297 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon (other) |
| Locations | 1 site (Dijon) |
| Trial ID | NCT06430021 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (RECRUITING)
Study contacts
- Study coordinator: Côme LEPAGE
- Email: come.lepage@chu-dijon.fr
- Phone: 0380293750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuroendocrine Tumors, MEN1 Mutation