PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT

Pancreatic Cancer Non-resectable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05802485
• Other study ID #: PANDORE-PANC-IPC 2021-082
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: February 1, 2029

Study information

• Verified date: March 2023
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: +33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 1, 2029
• Est. primary completion date: February 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer Non-resectable
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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