PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT

NCT ID: NCT05802485

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2029-02-01

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.

Conditions

Pancreatic Cancer Non-resectable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

collection of blood and tumor samples

Group Type: OTHER

collection of blood and tumor samples

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Dominique GENRE, MD

Role: CONTACT

drci.up@ipc.unicancer.fr

+33491223778

Other Identifiers

PANDORE-PANC-IPC 2021-082

Identifier Type: -

Identifier Source: org_study_id