PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT
1 other identifier
interventional
300
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedStudy Start
First participant enrolled
April 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
April 6, 2023
March 1, 2023
5.8 years
November 23, 2022
March 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
up to 6 years
Study Arms (1)
collection of blood and tumor samples
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2022
First Posted
April 6, 2023
Study Start
April 30, 2023
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
April 6, 2023
Record last verified: 2023-03