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CompletedNCT03599154GEMCIPANCUpdated May 24, 2021

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

An observational study in Pancreatic Cancer, sponsored by Centre Georges Francois Leclerc. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-24.

Sponsored by Centre Georges Francois Leclerc · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • Gemcitabine
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's enrollment of 100 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Centre Georges Francois Leclerc is the lead sponsor of 75 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Patient with pancreatic cancer

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Overall survival

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

    Time frame: average of 1 year

07

Study locations

1 site
  • Centre Georges François Leclerc
    Dijon, 21000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03599154
Lead sponsor
Centre Georges Francois Leclerc
Responsible party
Sponsor
First posted
Jul 26, 2018
Start date
Jan 30, 2018
Primary completion
Nov 25, 2020
Completion
Nov 25, 2020
Last update
May 24, 2021

Study contacts

François Ghiringhelli, PU PH
study director · Centre Georges François Leclerc, DIJON

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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