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Not yet recruitingNCT05802485Updated Apr 6, 2023

PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT

An interventional study of collection of blood and tumor samples in Pancreatic Cancer Non-resectable, sponsored by Institut Paoli-Calmettes. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-06.

Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Pancreatic Cancer Non-resectable
03

In context

Lead sponsor

Institut Paoli-Calmettes is the lead sponsor of 172 studies on the registry; 50 are open to participants now.

Browse Institut Paoli-Calmettes studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Other
    collection of blood and tumor samples

    Other: collection of blood and tumor samples

Interventions

  • Othercollection of blood and tumor samples

    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.

06

What researchers measure

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

    Time frame: up to 6 years

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2023; primary completion for Feb 2029, 69 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2022
First posted
Apr 6, 2023
StartEst.
Apr 30, 2023
Primary completionEst.
Feb 1, 2029
CompletionEst.
Feb 1, 2029
Last update
Apr 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05802485
Lead sponsor
Institut Paoli-Calmettes
Responsible party
Sponsor
First posted
Apr 6, 2023
Start date
Apr 30, 2023 (estimated)
Primary completion
Feb 1, 2029 (estimated)
Completion
Feb 1, 2029 (estimated)
Last update
Apr 6, 2023

Study contacts

Dominique GENRE, MD
Contact
drci.up@ipc.unicancer.fr
+33491223778

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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