PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT

Sponsor

Institut Paoli-Calmettes (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05802485

Collaborator

(none)

300

Enrollment

Arm

69.1

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Non-resectable	Other: collection of blood and tumor samples	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Apr 30, 2023

Anticipated Primary Completion Date :

Feb 1, 2029

Anticipated Study Completion Date :

Feb 1, 2029

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Predict response to systemic therapies in patients with non-metastatic pancreatic adenocarcinoma [up to 6 years]
Analysis of the impact of identified biomarkers on overall patient survival and tumour response

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Paoli-Calmettes

ClinicalTrials.gov Identifier:

NCT05802485

Other Study ID Numbers:

PANDORE-PANC-IPC 2021-082

First Posted:

Apr 6, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Apr 6, 2023