Pancreatic CancerGEMCIPANCNCT03599154
Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy
An observational study of Pancreatic Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2018to 25 Nov 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient with pancreatic cancer
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival is defined as survival between Day 1 of the first line of chemotherapy and death
Measured: average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start30 Jan 2018
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Ghiringhelli, PU PH, Study director, Centre Georges François Leclerc, DIJON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599154
- Sponsor's protocol ID
- GEMCIPANC
- Acronym
- GEMCIPANC
- Status last verified
- May 2021
- First submitted
- 12 Jul 2018
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy
- ClinicalTrials.gov ID
- NCT03599154
- Acronym / sponsor ID
- GEMCIPANC / GEMCIPANC
- Conditions
- Pancreatic Cancer
- Keywords
- Gemcitabine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with pancreatic cancer
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Ghiringhelli, PU PH study director
Centre Georges François Leclerc, DIJON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.