The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma (BIGHPANC)

Léon Bérard Center

Status: Active, not recruiting

Conditions: Pancreas Adenocarcinoma

Treatments: Procedure: Biological Samples

Study type: Observational

Funder types: Other

Identifiers

NCT03472716

BIGHPANC - ET17-113

Details and patient eligibility

About

The primary objective of this trial is to evaluate the correlation between the intensity of the protein big-h3 expression at tumoural microenvironment and the TNM/UICC staging (from I to IV) of pancreatic adenocarcinoma lesion.

Full description

The pancreatic adenocarcinoma is the most common pancreatic cancer. Currently, it represents the fourth cause of death by cancer in France. The diagnosis is often realized when the disease is at an advanced stage because of its delayed clinical expression. Only 20% of the patients are diagnosed at a stage enabling a tumour resection.

Scientists discovered a protein playing a key role: the βig-h3 protein. In mouse models, this protein is present in several stages of the tumorigenesis. A mutation of the gene Kras leads to the development of PANin (Pancreatic Intraepithelial Neoplasia) type precancerous lesions. The βig-h3 protein is early and highly expressed in the stroma around these lesions and in the pancreatic adenocarcinoma stroma. Moreover, studies showed that protein neutralization leads to a tumour size reduction by increasing the CD8+anti-tumor activity.

This protein is detected in the blood serum of patients suffering from a pancreatic adenocarcinoma. So, this protein which is secreted by the extracellular matrix could be a predictive marker for the pancreatic adenocarcinoma.

In this prospective, multicentric non-interventional study, it is anticipated to recruit 80 patients (20 per TNM/UICC stage).

Included patients will undergo two samples: A blood sample (5 ml) and a tumour sample (surgical exeresis piece or tumour tissue obtained for the initial diagnosis). In case of relapse, new samples will be performed.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years at the day of consenting to the study
• Patient with a potential pancreatic adenocarcinoma whatever the TNM/UICC stage
• Systematic treatment not initiated
• Signed and dated informed consent document.

Exclusion criteria

• Pregnant or breastfeeding woman
• Geographical, social or psychiatric reason preventing the patient from completing the study follow-up

Trial design

80 participants in 1 patient group

Samples

Description:

Included patients will undergo 2 biological samples : a 5-ml blood sample included in the standard care and a tumoral sample (from the surgical exeresis or from the initial diagnosis biopsy). Patients with a confirmed pancreatic carcinoma will be followed during 18 months in this cohort. In case of relapse, patients will have 2 new biological samples (blood and tumoral).

Treatment:

Procedure: Biological Samples