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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Georges François Leclerc

Dijon, 21000, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Contraindication to chemotherapy
Anti-tumor therapy, experimental or not, recent in the last 4 weeks before the inclusion of the patient
Active infection requiring antibiotics within 14 days before inclusion
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

Treatment and study plan

Primary outcomes

Overall survival

Time frame: average of 1 year

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

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Acronym: GEMCIPANC

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Jul 26, 2018
Registry last updated: May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed