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

NCT03472716 | Unknown

• 1 other identifier: BIGHPANC - ET17-113
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Adenocarcinoma

Keywords

Pancreatic adenocarcinoma; βig-h3; Pronostic marker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluation of the correlation of βig-h3 protein blood rate 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

  At inclusion and upon relpase assessed up to 36 months

• Evaluation of the correlation between βig-h3 protein expression intensity and patients clinical evolution

  6 months after patient's inclusion

• Evaluation of the the correlation between βig-h3 protein expression intensity and patients clinical evolution

  Assessed up to 36 months

• Evaluation of the correlation between βig-h3 protein expression intensity and patients clinical evolution

  Assessed up to 36 months

Study Arms (1)

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

Interventions

Biological Samples PROCEDURE

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)

Samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69008, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample (included in the standard care) at inclusion and in case of relapse. Initial tumoral sample from the surgical exeresis or from the sample obtained for the initial diagnosis (metastases biopsies) and new tumoural sample in case of relapse

Study Officials

• DE LA FOUCHARDIERE Christelle, Dr

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 21, 2018
• Study Start: May 22, 2018
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

FR (1)