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

May 21, 2021 updated by: Centre Georges Francois Leclerc

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Centre Georges François Leclerc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with pancreatic cancer

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Contraindication to chemotherapy
  2. Anti-tumor therapy, experimental or not, recent in the last 4 weeks before the inclusion of the patient
  3. Active infection requiring antibiotics within 14 days before inclusion
  4. Patients unable to understand, read and / or sign informed consent
  5. Persons benefiting from a protection system for adults (including tutorship and guardianship)
  6. Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Investigators

  • Study Director: François Ghiringhelli, PU PH, Centre Georges François Leclerc, DIJON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2018

Primary Completion (Actual)

November 25, 2020

Study Completion (Actual)

November 25, 2020

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

July 23, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEMCIPANC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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