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

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ClinicalTrials.gov Identifier: NCT03599154
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Tracking Information
First Submitted Date July 12, 2018
First Posted Date July 25, 2018
Last Update Posted Date July 25, 2018
Actual Study Start Date January 30, 2018
Actual Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy
Official Title Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Retention:   Samples Without DNA
Description:
blood sample
Sampling Method Probability Sample
Study Population Patient with pancreatic cancer
Condition Pancreatic Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 23, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 30, 2020
Actual Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: François Ghiringhelli, PU PH 03.80.73.75.00 FGhiringhelli@cgfl.fr
Contact: Emilie REDERSTORFF 03 45 34 81 16 erederstorff@cgfl.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03599154
Other Study ID Numbers GEMCIPANC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Georges Francois Leclerc
Study Sponsor Centre Georges Francois Leclerc
Collaborators Not Provided
Investigators
Study Director: François Ghiringhelli, PU PH Centre Georges François Leclerc, DIJON
PRS Account Centre Georges Francois Leclerc
Verification Date July 2018