Pancreas CancerNCT05248750
Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma
An observational study of Pancreas Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreas Cancer
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jul 2021to 10 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study concerns consecutive individuals with a solid pancreatic lesion who will undergo diagnostic EUS-FNB over a 3 year period. Those with a histological diagnosis of PDAC will be enrolled in the study. Enrollment will include patients with unresectable disease, which can be divided in different stages, i.e. borderline resectable, locally advanced, and metastatic.
Who may be able to join
- Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings
- Availability of biopsies obtained during EUS-FNB
- Histological diagnosis of pancreatic ductal adenocarcinoma of any stage
- Patients must be fit for chemotherapy administration
- They have to express their willingness to be followed up at our pancreatic high volume centers
- Age >18 and <80 years
- Able to sign informed consent
Who cannot join
- Histological diagnoses other than pancreatic ductal adenocarcinoma
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Carolina Gualtieri contact
Italy1 site, 1 recruiting
- Recruiting
"Agostino Gemelli" Hospital, Catholic University of Sacred Heart
Rome, Lazio, 00168
Guido Costamagna, MD, Prof., +39.0630156580, gcostamagna@rm.unicatt.it
MD
About this study
Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.
- Conditions
- Pancreas Cancer
- Keywords
- pancreatic cancer, endoscopic ultrasound (EUS), personalized medicine
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free-survival (PFS)
To assess the impact of comprehensive genetic, stromal, and immunological factors on PFS defined as the time from the date of trial entry until disease progression or relapse.
Measured: From date of enrollment assessed until death or up to 2 years
Overall survival
To assess the impact of comprehensive genetic, stromal, and immunological factors on Overall survival defined as the length of time (in days) between the treatment date and the date of death.
Measured: From date of enrollment assessed until death or up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start22 Jul 2021
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Costamagna, Catholic University of the Sacred Heart
- Investigators
- Alberto Larghi, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248750
- Sponsor's protocol ID
- PDAC AIRC
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2022
- Last updated
- 13 Feb 2024
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05248750
- Acronym / sponsor ID
- PDAC AIRC
- Conditions
- Pancreas Cancer
- Keywords
- pancreatic cancer, endoscopic ultrasound (EUS), personalized medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 21 Feb 2022 (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.
Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns consecutive individuals with a solid pancreatic lesion who will undergo diagnostic EUS-FNB over a 3 year period. Those with a histological diagnosis of PDAC will be enrolled in the study. Enrollment will include patients with unresectable disease, which can be divided in different stages, i.e. borderline resectable, locally advanced, and metastatic.
Key inclusion criteria (7 listed)
- Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings
- Availability of biopsies obtained during EUS-FNB
- Histological diagnosis of pancreatic ductal adenocarcinoma of any stage
- Patients must be fit for chemotherapy administration
- They have to express their willingness to be followed up at our pancreatic high volume centers
Key exclusion criteria (2 listed)
- Histological diagnoses other than pancreatic ductal adenocarcinoma
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free-survival (PFS)
Time frame: From date of enrollment assessed until death or up to 2 years
To assess the impact of comprehensive genetic, stromal, and immunological factors on PFS defined as the time from the date of trial entry until disease progression or relapse.
Overall survival
Time frame: From date of enrollment assessed until death or up to 2 years
To assess the impact of comprehensive genetic, stromal, and immunological factors on Overall survival defined as the length of time (in days) between the treatment date and the date of death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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. This study is not recruiting at the moment.
Carolina Gualtieri contact
Alberto Larghi, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Larghi, MD (+390630156580, alberto.larghi@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free-survival (PFS) (time frame: From date of enrollment assessed until death or up to 2 years). The study lists 2 primary outcomes in all. 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 13 Feb 2024.