Pancreatic Cancer Non-resectableNCT05802485
PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT
A study testing collection of blood and tumor samples in people with Pancreatic Cancer Non-resectable, run by Institut Paoli-Calmettes.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Non-resectable
- What is being tested?
- collection of blood and tumor samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2023to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Pancreatic Cancer Non-resectable
- Being tested
- collection of blood and tumor samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of blood and tumor samplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| collection of blood and tumor samples | Other | Not described Receives: Other: collection of blood and tumor samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start30 Apr 2023 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Non-resectableStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802485
- Sponsor's protocol ID
- PANDORE-PANC-IPC 2021-082
- Status last verified
- Mar 2023
- First submitted
- 23 Nov 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT: PANDORE-PANC-IPC 2021-082
- ClinicalTrials.gov ID
- NCT05802485
- Acronym / sponsor ID
- PANDORE-PANC-IPC 2021-082
- Conditions
- Pancreatic Cancer Non-resectable
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| collection of blood and tumor samples | Other | Other: collection of blood and tumor samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of blood and tumor samplesThe 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. | Other | collection of blood and tumor samples |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing collection of blood and tumor samples in people with Pancreatic Cancer Non-resectable, run by Institut Paoli-Calmettes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENRE, MD (+33491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predict response to systemic therapies in patients with non-metastatic pancreatic adenocarcinoma (time frame: up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.