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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreas Adenocarcinoma
• Intervention / Treatment: Procedure: Biological Samples

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Centre Léon Bérard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting a pancreatic adenocarcinoma (TNM/UICC from I to IV) having given a written consent for participating to the study. Patients are to be followed up until the LVLP (minimum duration: 18 months, maximum: 36 months)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Samples; 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).	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the correlation between the intensity of the protein βig-h3 expression at tumoural microenvironment and the TNM/UICC (from I to IV) of pancreatic adenocarcinoma lesion	Correlation between the intensity of the protein βig-h3 expression at tumoural microenvironment and the TNM/UICC (from I to IV) of pancreatic adenocarcinoma lesionimmunohistochemical analysis of pancreatic adenocarcinoma	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the correlation of βig-h3 protein blood rate and the pancreatic adenocarcinoma TNM/UICC staging	Correlation between βig-h3 protein blood rate (ELISA) and the pancreatic adenocarcinoma TNM/UICC staging	At inclusion and upon relpase assessed up to 36 months
Evaluation of the correlation between the βig-h3 protein expression intensity in the tumoural microenvironment and the immune infiltrate LT CD8+ of pancreatic adenocarcinoma	Correlation between the βig-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
Evaluation of the correlation between βig-h3 protein expression intensity and patients clinical evolution	Correlation between βig-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
Evaluation of the the correlation between βig-h3 protein expression intensity and patients clinical evolution	Correlation between βig-h3 protein expression intensity and Overall Survival	Assessed up to 36 months
Evaluation of the correlation between βig-h3 protein expression intensity and patients clinical evolution	Correlation between βig-h3 protein expression intensity and Progression Free Survival	Assessed up to 36 months

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: DE LA FOUCHARDIERE Christelle, Dr, Centre Léon Bérard

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Pancreatic adenocarcinoma; βig-h3; Pronostic marker
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: BIGHPANC - ET17-113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No