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NCT Number: NCT05802485

PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

collection of blood and tumor samples

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique GENRE, MD

CONTACT

[email protected]

+33491223778

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Apr 6, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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