Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy

NCT03599154 | Completed

• 1 other identifier: GEMCIPANC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic cancer has a 5-year overall survival rate around 5%. It is the 6th most common cancer in France (11 600 new annual cases in 2012) and the 4th leading cause of cancer deaths in France and Europe. Many translational research has tried to identify biomarkers in pancreatic cancer. Only the expression of hENT1 evaluated on the tumor tissue with the mouse antibody seems really relevant by providing a predictive value of the effectiveness of gemcitabine adjuvant. In a metastatic situation, there is no predictive marker of the effectiveness of chemotherapy treatments. GemciTest(TM), studied in this study, is developed by the company Acobiom. Test based on the qRT-PCR technology that allows the establishment of a molecular signature of 10 genes that showed its interest as a biomarker in 60 patients with metastatic pancreatic adenocarcinoma treated with gemcitabine. Retrospective analysis differentiated 2 patient populations:

• 22 patients with a "favorable" expression gene with a median survival of 14.9 months
• 35 patients with an "adverse" expression gene with a median survival of 5.1 months Primary objective: To evaluate in patients with pancreatic cancer, treated with Gemcitabine alone or combined (nab-paclitaxel) or with Folfirinox, the prognostic value of the GemciTest(TM) test on overall survival and response to treatment. To realize this study, only one 2.5 mL blood sample is taken before starting chemotherapy. The standard practice data is then saved. 100 patients will be included.

Conditions

Pancreatic Cancer

Keywords

Gemcitabine

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival is defined as survival between Day 1 of the first line of chemotherapy and death

  average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with pancreatic cancer

You may qualify if:

• Cytologically or histologically confirmed pancreatic cancer
• Patient seeking first-line chemotherapy for pancreatic cancer
• Age\> 18 years
• Presence of at least 1 measurable tumor lesion according to RECIST 1.1 criteria
• Performance index ≤ 2
• Patient able and willing to comply with the study procedures according to the protocol
• Patient able to understand, sign and date informed consent
• Affiliation to a social security scheme.

You may not qualify if:

• Contraindication to chemotherapy
• Patients unable to understand, read and / or sign informed consent
• Persons benefiting from a protection system for adults (including tutorship and guardianship)
• Pregnant or lactating women

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges François Leclerc

Dijon, 21000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• François Ghiringhelli, PU PH

  Centre Georges François Leclerc, DIJON

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 26, 2018
• Study Start: January 30, 2018
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

FR (1)