Pancreas CancerNCT04246710
Pancreatic Cancer Molecular Sub-classification Using Endoscopic Ultrasound Tissue Core Biopsy Samples
An observational study of Pancreas Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
This study evaluated the feasibility and reliability of PDAC molecular subtyping on tissue core biopsies samples acquired under EUS guidance. Moreover, this study will assess the impact of molecular subtypes assessed on EUS-FNB samples in patients with resectable and unresectable (locally advanced, advanced, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreas Cancer
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jan 2018to 2 Jun 2024
- 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. Those with a histological diagnosis of PDAC will be enrolled in the study. Enrollment will include patients with resectable disease and those with unresectable disease, which can be divided in different stages, i.e. borderline resectable, locally advanced, advanced, and metastatic.
Who may be able to join
- Patients referred to EUS with FNB in the suspect of pancreatic cancer
- Availability of biopsies obtained during EUS-FNB
- Histological diagnosis of pancreatic ductal adenocarcinoma of any stage
- Age >18 and <80 years
- Willing to be followed up at the Fondazione Policlinico A. Gemelli University Hospital
- Able to sign informed consent
Who cannot join
- Histological diagnoses other than pancreatic ductal adenocarcinoma
- Pregnancy or lactation
- Unable to sigh informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pancreatic Cancer Molecular Sub-classification for Prognostic Stratification and Individualized Therapy Using Endoscopic Ultrasound Tissue Core Biopsy Samples
This study evaluated the feasibility and reliability of PDAC molecular subtyping on tissue core biopsies samples acquired under EUS guidance. Moreover, this study will assess the impact of molecular subtypes assessed on EUS-FNB samples in patients with resectable and unresectable (locally advanced, advanced, and metastatic) PDAC undergoing chemotherapy on treatment response and survival and the utility in monitoring disease response to therapy and early occurrence of disease relapse using the TaqMan RNA assay in serum
Read the detailed description
PDAC patients are categorised as resectable, borderline resectable, locally advanced, metastatic and recurrent. Substantial neoplastic tissue is only available for the resectable group. This is unfortunate as the other groups are those that would benefit the most from molecular characterization and identification of markers, which may be predictive and/or provide therapeutic stratification. For these categories of patients, only fine needle aspiration or small biopsies could be obtained until now. However, the introduction of new needles, specifically designed to acquire larger high quality biopsy samples under endoscopic ultrasound (EUS), has now made it possible to test prognostic, predictive and therapeutic stratification markers. However, the applicability of EUS-fine needle biopsy (EUS-FNB) samples for this purpose has yet to be clinically validated. The working hypothesis of this proposal is that the molecular sub-classification of PDAC on EUS-FNB tissue samples could be applied for prognostic stratification and therapeutic decision strategies in both resectable and unresectable patients using DNA and RNA biomarkers.
- Conditions
- Pancreas Cancer
- Keywords
- pancreatic cancer, EUS, molecular subtyping, personalized medicine
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of PDAC molecular subtyping on biopsy samples
Number of patients in whom molecular subtyping on biopsy samples is obtained
Measured: At 6 months
Reliability of PDAC molecular subtyping on biopsy samples
concordance between molecular subtyping on biopsy samples and surgery specimens
Measured: At 1 year
Secondary outcomes (2)
Progression-free-survival (PFS)
To assess the impact of molecular subtypes assessed on EUS-FNB samples 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 3 years
Overall survival
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 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start28 Jan 2018
- Primary completion1 Jun 2024 (estimated)
- Study completion2 Jun 2024 (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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Guido Costamagna, Catholic University of the Sacred Heart
- Investigators
- Alberto Larghi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246710
- Sponsor's protocol ID
- PDAC-SUBCLASS
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Pancreatic Cancer Molecular Sub-classification for Prognostic Stratification and Individualized Therapy Using Endoscopic Ultrasound Tissue Core Biopsy Samples
- ClinicalTrials.gov ID
- NCT04246710
- Acronym / sponsor ID
- PDAC-SUBCLASS
- Conditions
- Pancreas Cancer
- Keywords
- pancreatic cancer, EUS, molecular subtyping, personalized medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 2 Jun 2024 (estimated)
- First posted
- 29 Jan 2020 (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.
This study evaluated the feasibility and reliability of PDAC molecular subtyping on tissue core biopsies samples acquired under EUS guidance. Moreover, this study will assess the impact of molecular subtypes assessed on EUS-FNB samples in patients with resectable and unresectable (locally advanced, advanced, and metastatic) PDAC undergoing chemotherapy on treatment response and survival and the utility in monitoring disease response to therapy and early occurrence of disease relapse using the TaqMan RNA assay in serum
Detailed description
PDAC patients are categorised as resectable, borderline resectable, locally advanced, metastatic and recurrent. Substantial neoplastic tissue is only available for the resectable group. This is unfortunate as the other groups are those that would benefit the most from molecular characterization and identification of markers, which may be predictive and/or provide therapeutic stratification. For these categories of patients, only fine needle aspiration or small biopsies could be obtained until now. However, the introduction of new needles, specifically designed to acquire larger high quality biopsy samples under endoscopic ultrasound (EUS), has now made it possible to test prognostic, predictive and therapeutic stratification markers. However, the applicability of EUS-fine needle biopsy (EUS-FNB) samples for this purpose has yet to be clinically validated. The working hypothesis of this proposal is that the molecular sub-classification of PDAC on EUS-FNB tissue samples could be applied for prognostic stratification and therapeutic decision strategies in both resectable and unresectable patients using DNA and RNA biomarkers.
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. Those with a histological diagnosis of PDAC will be enrolled in the study. Enrollment will include patients with resectable disease and those with unresectable disease, which can be divided in different stages, i.e. borderline resectable, locally advanced, advanced, and metastatic.
Key inclusion criteria (6 listed)
- Patients referred to EUS with FNB in the suspect of pancreatic cancer
- Availability of biopsies obtained during EUS-FNB
- Histological diagnosis of pancreatic ductal adenocarcinoma of any stage
- Age >18 and <80 years
- Willing to be followed up at the Fondazione Policlinico A. Gemelli University Hospital
Key exclusion criteria (3 listed)
- Histological diagnoses other than pancreatic ductal adenocarcinoma
- Pregnancy or lactation
- Unable to sigh informed consent
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
Feasibility of PDAC molecular subtyping on biopsy samples
Time frame: At 6 months
Number of patients in whom molecular subtyping on biopsy samples is obtained
Reliability of PDAC molecular subtyping on biopsy samples
Time frame: At 1 year
concordance between molecular subtyping on biopsy samples and surgery specimens
2 secondary outcomes
Progression-free-survival (PFS)
Time frame: From date of enrollment assessed until death or up to 3 years
Overall survival
Time frame: From date of enrollment assessed until death or up to 3 years
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.
- Individual participant dataSharing planned: No
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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.
Alberto Larghi 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 6 inclusion and 3 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of PDAC molecular subtyping on biopsy samples (time frame: At 6 months). 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.