Clinical trial NCT03472716: The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma (BIGHPANC)
Official title: The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreas Adenocarcinoma
Keywords: Pancreatic adenocarcinoma
βig-h3
Pronostic marker
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At inclusion
Secondary outcomes:
measure: Evaluation of the correlation of βig-h3 protein blood rate and the pancreatic adenocarcinoma TNM/UICC staging
timeFrame: At inclusion and upon relpase assessed up to 36 months
measure: Evaluation of the correlation between the βig-h3 protein expression intensity in the tumoural microenvironment and the immune infiltrate LT CD8+ of pancreatic adenocarcinoma
timeFrame: At inclusion and upon relpase assessed up to 36 months
measure: Evaluation of the correlation between βig-h3 protein expression intensity and patients clinical evolution
timeFrame: 6 months after patient's inclusion
measure: Evaluation of the the correlation between βig-h3 protein expression intensity and patients clinical evolution
timeFrame: Assessed up to 36 months
measure: Evaluation of the correlation between βig-h3 protein expression intensity and patients clinical evolution
timeFrame: Assessed up to 36 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: DE LA FOUCHARDIERE Christelle, Dr
role: PRINCIPAL_INVESTIGATOR
References: