Back to resultsPANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT
Primary Purpose
Pancreatic Cancer Non-resectable
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
collection of blood and tumor samples
Sponsored by
About this trial
This is an interventional other trial for Pancreatic Cancer Non-resectable
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
collection of blood and tumor samples
Arm Description
Outcomes
Primary Outcome Measures
Predict response to systemic therapies in patients with non-metastatic pancreatic adenocarcinoma
Analysis of the impact of identified biomarkers on overall patient survival and tumour response
Secondary Outcome Measures
Full Information
NCT ID
NCT05802485
First Posted
November 23, 2022
Last Updated
March 27, 2023
Sponsor
Institut Paoli-Calmettes
1. Study Identification
Unique Protocol Identification Number
NCT05802485
Brief Title
PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT
Official Title
PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT: PANDORE-PANC-IPC 2021-082
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2023 (Anticipated)
Primary Completion Date
February 1, 2029 (Anticipated)
Study Completion Date
February 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer Non-resectable
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
collection of blood and tumor samples
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
collection of blood and tumor samples
Intervention 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.
Primary Outcome Measure Information:
Title
Predict response to systemic therapies in patients with non-metastatic pancreatic adenocarcinoma
Description
Analysis of the impact of identified biomarkers on overall patient survival and tumour response
Time Frame
up to 6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
+33491223778
Email
drci.up@ipc.unicancer.fr
12. IPD Sharing Statement
Learn more about this trial
PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT
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