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

Pancreas Adenocarcinoma Clinical Trial

— BIGHPANC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03472716
• Other study ID #: BIGHPANC - ET17-113
• Status: Active, not recruiting
• Start date: May 22, 2018
• Est. completion date: September 2023

Study information

• Verified date: December 2022
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas Adenocarcinoma

Intervention

Procedure:
• Biological Samples
5 ml blood sample and one tumoural sample (either a fresh biopsy or the initial diagnosis biopsy). In case of relapse, new samples will be performed (blood and tumoral samples)

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the correlation between the intensity of the protein ßig-h3 expression at tumoural microenvironment and the TNM/UICC (from I to IV) of pancreatic adenocarcinoma lesion	Correlation between the intensity of the protein ßig-h3 expression at tumoural microenvironment and the TNM/UICC (from I to IV) of pancreatic adenocarcinoma lesionimmunohistochemical analysis of pancreatic adenocarcinoma	At inclusion
Secondary	Evaluation of the correlation of ßig-h3 protein blood rate and the pancreatic adenocarcinoma TNM/UICC staging	Correlation between ßig-h3 protein blood rate (ELISA) and the pancreatic adenocarcinoma TNM/UICC staging	At inclusion and upon relpase assessed up to 36 months
Secondary	Evaluation of the correlation between the ßig-h3 protein expression intensity in the tumoural microenvironment and the immune infiltrate LT CD8+ of pancreatic adenocarcinoma	Correlation between the ßig-h3 protein expression intensity in the tumoural microenvironment and the immune infiltrate LT CD8+ of pancreatic adenocarcinoma	At inclusion and upon relpase assessed up to 36 months
Secondary	Evaluation of the correlation between ßig-h3 protein expression intensity and patients clinical evolution	Correlation between ßig-h3 protein expression intensity and patients clinical evolution (6-month objective response rate according to RECIST 1.1 criteria)	6 months after patient's inclusion
Secondary	Evaluation of the the correlation between ßig-h3 protein expression intensity and patients clinical evolution	Correlation between ßig-h3 protein expression intensity and Overall Survival	Assessed up to 36 months
Secondary	Evaluation of the correlation between ßig-h3 protein expression intensity and patients clinical evolution	Correlation between ßig-h3 protein expression intensity and Progression Free Survival	Assessed up to 36 months