PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT

March 27, 2023 updated by: Institut Paoli-Calmettes

PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT: PANDORE-PANC-IPC 2021-082

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: collection of blood and tumor samples
Other: collection 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predict response to systemic therapies in patients with non-metastatic pancreatic adenocarcinoma
Time Frame: up to 6 years
Analysis of the impact of identified biomarkers on overall patient survival and tumour response
up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 30, 2023

Primary Completion (Anticipated)

February 1, 2029

Study Completion (Anticipated)

February 1, 2029

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANDORE-PANC-IPC 2021-082

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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