Pancreatic CancerPancreas-CGENCT02818907
Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable
A study testing Additional biological samples in people with Pancreatic Cancer, run by Centre Hospitalier Universitaire de Besancon at 8 sites in France.
Trial summary
This study aims to collect clinical, biological and quality of life data from patients with a borderline or resectable pancreatic cancer. It will collect information from the date of diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end of the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Additional biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 8 sitesFrance
- Study dates
- 19 May 2016to 7 Jul 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with exocrine resectable pancreatic adenocarcinoma or potentially resectable (that after neoadjuvant treatment are considered appropriate candidates for resection)
- Histologically or cytologically documented diagnosis of exocrine pancreatic adenocarcinoma
- Written informed consent obtained prior enrollment in the study
Who cannot join
- other types of pancreatic cancer, in particular endocrine tumor or acinar cells
- ampulloma
- metastatic disease
- other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer
- patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
- patient under guardianship, curator or under the protection of justice.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre Hospitalier Régional Universitaire de Besançon
Besançon, 25000
Centre Georges François Leclerc
Dijon
Centre Hospitalier Universitaire de Dijon
Dijon
Centre Hospitalier Universitaire de Nancy
Nancy
Institut de cancérologie de Lorraine
Nancy
Centre Hospitalier Universitaire Robert Debré
Reims
Centre Paul Strauss
Strasbourg
CHU de Strasbourg - Hautepierre
Strasbourg
About this study
Official title: Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort
This study aims to collect clinical, biological and quality of life data from patients with a borderline or resectable pancreatic cancer. It will collect information from the date of diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end of the treatment. The database will be updated at each patient's visit. Biological samples will include: tumor, and plasma. Epidemiological data will also be collected, whereas Quality of life will be assessed by the EORTC standard. The objectives of this database are to identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high quality standard research protocol.
- Conditions
- Pancreatic Cancer
- Being tested
- Additional biological samples
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional biological samplesOther
blood and tumor tissue samples
| Study group | Role | What they receive |
|---|---|---|
| Additional biological samples | Other | Additional blood samples will be realized specifically to the study at baseline, after neoadjuvant chemotherapy (if applicable) and before surgery, 1 month after surgery and 1 month after the last adjuvant chemotherapy cycle.
Peripheral blood mononuclear cell (PBMC), plasma and circulating tumor DNA and RNA will be collected.
Tumor tissue will be collected during surgery. Receives: Other: Additional biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014)
DATECAN = Definition for the Assessment of Time-to-event Endpoints in CANcer trials
Measured: date of first disease apparition [within 3 years after the enrollment of the last patient]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start19 May 2016
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
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.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Cancéropôle Grand-Est
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818907
- Sponsor's protocol ID
- Pancreas-CGE
- Acronym
- Pancreas-CGE
- Status last verified
- Sep 2024
- First submitted
- 28 Jun 2016
- Last updated
- 19 Sep 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort
- ClinicalTrials.gov ID
- NCT02818907
- Acronym / sponsor ID
- Pancreas-CGE / Pancreas-CGE
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Cancéropôle Grand-Est
- Study start
- 19 May 2016 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 30 Jun 2016 (estimated)
- 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.
This study aims to collect clinical, biological and quality of life data from patients with a borderline or resectable pancreatic cancer. It will collect information from the date of diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end of the treatment. The database will be updated at each patient's visit. Biological samples will include: tumor, and plasma. Epidemiological data will also be collected, whereas Quality of life will be assessed by the EORTC standard. The objectives of this database are to identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high quality standard research protocol.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional biological samples | Other | Other: Additional biological samplesAdditional blood samples will be realized specifically to the study at baseline, after neoadjuvant chemotherapy (if applicable) and before surgery, 1 month after surgery and 1 month after the last adjuvant chemotherapy cycle. Peripheral blood mononuclear cell (PBMC), plasma and circulating tumor DNA and RNA will be collected. Tumor tissue will be collected during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with exocrine resectable pancreatic adenocarcinoma or potentially resectable (that after neoadjuvant treatment are considered appropriate candidates for resection)
- Histologically or cytologically documented diagnosis of exocrine pancreatic adenocarcinoma
- Written informed consent obtained prior enrollment in the study
Key exclusion criteria (6 listed)
- other types of pancreatic cancer, in particular endocrine tumor or acinar cells
- ampulloma
- metastatic disease
- other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer
- patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional biological samplesblood and tumor tissue samples | Other | Additional biological samples |
Primary outcome
disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014)
Time frame: date of first disease apparition [within 3 years after the enrollment of the last patient]
DATECAN = Definition for the Assessment of Time-to-event Endpoints in CANcer trials
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 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional biological samples in people with Pancreatic Cancer, run by Centre Hospitalier Universitaire de Besancon at 8 sites 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 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014) (time frame: date of first disease apparition [within 3 years after the enrollment of the last patient]). 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 19 Sep 2024.