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Trial Title:
PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT
NCT ID:
NCT05802485
Condition:
Pancreatic Cancer Non-resectable
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
collection of blood and tumor samples
Description:
The study consists of the collection of a 25 ml blood sample:
- Before the start of treatment
- Approximately 2 months after the start of induction chemotherapy
- At the end of induction chemotherapy
- Prior to local treatment (radiotherapy, surgery)
- At the time of tumor progression
At the time of collection of tumor material:
- During the initial diagnostic biopsy
- On the operating room in case of surgery
- During a tumor biopsy in case of recurrence or progression (optional) and a
questionnaire evaluating the patient's spontaneous physical activities.
Arm group label:
collection of blood and tumor samples
Summary:
The study consists of a 25 ml blood sample collection:
- Before the start of treatment
- Approximately 2 months after the start of induction chemotherapy
- At the end of induction chemotherapy
- Prior to local treatment (radiotherapy, surgery)
- At the time of tumor progression
Collection of tumor material:
- During the initial diagnostic biopsy
- On the operating room in case of surgery
- At tumor biopsy in case of recurrence or progression (optional) As well as the
completion of a questionnaire at inclusion.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Non-metastatic pancreatic adenocarcinoma that is not immediately resectable
(borderline and locally advanced tumors according to the NCCN 2020 classification)
- No previous treatment with surgery or chemotherapy
- Age > 18 years
- General condition WHO 0-2 (patient whose general condition can allow medical
treatment or surgery)
- Therapeutic management at the Paoli-Calmettes Institute
- Signature of the informed consent specific to the PANDORE-PANC study
- Patient affiliated to a social security system or benefiting from such a system
Exclusion Criteria:
- Metastatic disease
- Pancreatic tumor of a histological type other than adenocarcinoma
- Other tumor under treatment or for which treatments have been completed for < 1 year
- Pregnant or breastfeeding women
- Person in an emergency situation
- Person of legal age under legal protection (guardianship, curatorship or safeguard
of justice) or unable to give consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 30, 2023
Completion date:
February 1, 2029
Lead sponsor:
Agency:
Institut Paoli-Calmettes
Agency class:
Other
Source:
Institut Paoli-Calmettes
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05802485