Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jul 1;13(1):91.
doi: 10.1186/s40364-025-00793-z.

Diagnostic value of the wnt target and cancer-associated blood biomarker hPG80: ONCOPRO case-control prospective study

Benoit You  1   2   3 , Sebastien Couraud  4   5 , Philippe Ceruse  4   6 , Lionel Badet  4   7 , Philippe Paparel  4 , Alice Durand  4   8 , Marielle Guillet  4   8 , Philippe Merle  4   9 , Gaelle Lescuyer  4   10 , Charles-André Philip  4   11 , Francois Ducray  4   12 , Mathieu Pioche  4   8 , Lionel Karlin  4   13 , Jean-Christophe Lifante  4   14 , Olivier Glehen  4   15 , Pierre-Adrien Bolze  4 , Marion Chauvenet  4   16 , Carole Langlois-Jacques  4   17   18 , Fabien Subtil  4   17   18 , Marie Piecyk  4   10 , Aurore Carrot  4 , Dominique Joubert  19 , Alexandre Prieur  19 , Berengere Vire  19 , Sara Calattini  4 , Lea Payen  4   10   20
Affiliations

Diagnostic value of the wnt target and cancer-associated blood biomarker hPG80: ONCOPRO case-control prospective study

Benoit You et al. Biomark Res. .

Abstract

Background: hPG80 (circulating progastrin), initially recognized for its oncogenic properties due to its direct link to the Wnt signaling pathway, is secreted by cancer cells and detectable in the blood of cancer patients. The ONCOPRO centralized case-control study (NCT03787056) was designed to prospectively evaluate the diagnostic utility of hPG80 in patients with 16 different types of cancer.

Methods: hPG80 levels were measured in 421 patients with 16 newly diagnosed cancers (median age 65.6 years old) using the DxPG80.Lab kit (Biodena Care). The diagnostic performance of hPG80 (the primary endpoint) was assessed by comparing baseline hPG80 levels in cancer patients with those of 330 asymptomatic aged-matched healthy subjects from the general population.

Results: Between 2018 and 2022, a total of 506 cancer patients were enrolled in the study, with 421 assessable across 16 distinct cancer cohorts. hPG80 concentrations were significantly higher in cancer patients compared to the healthy population (median 3.8 [IQR: 1.0-11.1] vs. 1.9 [IQR: 0.6-4.2] pM, P < 0.0001). hPG80 levels were not impacted by renal failure, liver dysfunction, or cancer-associated inflammation. The diagnostic accuracy in cancer patients was ROC AUC 0.63, 95% CI = [0.59-0.67]. The highest diagnostic accuracy was seen in patients with lung cancer (AUC 0.75, 95% CI [0.68-0.82]; specificity = 88% for hPG80 > 7.73 pM in patients aged > 58 years old) and hepatocellular carcinoma HCC (ROC AUC 0.75, 95% CI [0.66-083]; specificity = 88% for hPG80 > 7.73 pM in patients aged > 58 years old).

Conclusions: This large prospective study confirms that cancer patients have significantly higher hPG80 blood concentration compared to the healthy population. Incorporating this straightforward ELISA assay into screening programs is warranted.

Trial registration: NCT03787056.

Keywords: Biomarkers, tumor; Early detection of Cancer; Prospective studies; Wnt signaling pathway.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics and consent to participate declarations: All patients gave their consent and signed the informed consent. The protocol, the written information sheet and the consent form for the study obtained a favorable opinion from to ethics committee Ile de France VI on October 3rd 2018. This notification was transmitted to the French health authority ANSM. All Protocol amendments were approved by the same ethic committee. Consent for publication: Not applicable. Competing interests: DJ, AP, and BV are employed by Biodena Care (Progastrin Manufacturing). All the other coauthors have no conflict of interest to disclose.

Figures

Fig. 1
Fig. 1
ONCOPRO study design with biological sampling strategies for (A) curative intent or non-curative intent treatments, and (B) during systemic or local treatments
Fig. 2
Fig. 2
Flowchart of ONCOPRO study
Fig. 3
Fig. 3
Diagnostic value of hPG80 in cancer patient cases compared to asymptomatic healthy subjects. (A) Box-plots of hPG80 concentration. (B) ROC curve area under the curve
Fig. 4
Fig. 4
hPG80 concentrations in the large cancer patient cohorts and the asymptomatic healthy subjects. The number of patients is indicated on the x-axis
Fig. 5
Fig. 5
Diagnostic value of hPG80 in patients with lung cancer (A) and HCC (B) aged 58 years or older, compared to asymptomatic healthy subjects
See this image and copyright information in PMC

References

    1. Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023;73:17–48. - PubMed
    1. Shiels MS, Lipkowitz S, Campos NG, et al. Opportunities for achieving the Cancer moonshot goal of a 50% reduction in Cancer mortality by 2047. Cancer Discov. 2023;13:1084–99. - PMC - PubMed
    1. Rubinstein WS, Patriotis C, Dickherber A, et al. Cancer screening with multicancer detection tests: A translational science review. CA Cancer J Clin. 2024;74:368–82. - PMC - PubMed
    1. You B, Mercier F, Assenat E, et al. The oncogenic and druggable hPG80 (Progastrin) is overexpressed in multiple cancers and detected in the blood of patients. EBioMedicine. 2020;51:102574. - PMC - PubMed
    1. Koh TJ, Bulitta CJ, Fleming JV, Dockray GJ, Varro A, Wang TC. Gastrin is a target of the beta-catenin/TCF-4 growth-signaling pathway in a model of intestinal polyposis. J Clin Invest. 2000;106:533–9. - PMC - PubMed

Associated data

LinkOut - more resources