Microbial ColonizationPANDEMICNCT04274972
The Microbiome of Pancreatic Cancer: "PANDEMIC" Study
An observational study of Microbial Colonization and Pancreas Cancer, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
Microbiome in patients affected by pancreatic ductal adenocarcinoma may present specific and identifiable patterns. These variations could affect the surgical outcome and increase the risk of life-threatening infections supported by multidrug-resistant bacteria. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Microbial Colonization, Pancreas Cancer, Pancreas Infection
- What is being tested?
- Microbiome evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 31 Dec 2024
- How long will I take part?
- 3 Months
- 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 65 years
- All sexes
- Adult, Older adult
Study population: All patients, affected by a resectable PDAC of the head of the pancreas, visited at the Department of Pancreatic Surgery of Verona, will be enrolled. All the patients must be scheduled for an elective PD. The patients will be submitted to the routinely diagnostic preoperative work-up.
Who may be able to join
- age between 18 and 65 years;
- PDAC lesion of the pancreatic head confirmed by preoperative histology or cytology;
- Scheduled for elective PD;
- ASA score < 4
- The ability of the subject to understand the character and individual consequences of the clinical trial
- Written informed consent
Who cannot join
- Patients with a degenerated pancreatic cyst lesion
- Neoadjuvant treatment (both radio and chemotherapy)
- Other current malignancies
- Antibiotic therapy during 4 weeks before surgery
- History of gastrointestinal tract resections or chronic gastrointestinal diseases
- Pregnant or breastfeeding patients
Show all 9Show fewer
- Patients undergoing emergency surgery
- ASA score > 4
- Impaired mental state or language problems
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUI Verona
Verona, 37124
Matteo De Pastena, MD, 0039 0458126254, m.depastena@gmail.com
Giovanni Marchegiani, MD, 0039 0458126254, giovanni.marchegiani@aovr.veneto.it
About this study
Microbiome in patients affected by pancreatic ductal adenocarcinoma may present specific and identifiable patterns. These variations could affect the surgical outcome and increase the risk of life-threatening infections supported by multidrug-resistant bacteria. The identification of microbial signatures with tumor specificity may have a potential role in postoperative risk stratification. Variation of pancreatic, intestinal or bile microbiome and their relationship can be investigated and measured as promising tools in order to predict and overcome the clinical and infectious burden imposed by MDR infections. The prospect of a potential role for probiotics to promote competition against the pathogens and to improve the gastrointestinal barrier integrity has also been raised. Moreover, if the bacterial composition in human PDAC was confirmed to be distinct from that of the normal pancreas, microbiome variation could be used as a potential biomarker, to assess the potential for malignancy in precursor neoplastic lesions. However, we believe that a preliminary and explorative study is necessary. The study aims to outline the pancreatic microbiome of patients who undergo upfront PD for resectable PDAC and to characterize the possible association between bacterial composition and the occurrence of post-operative complications, particularly POPF and IC.
Read the detailed description
Pancreatic cancer is predicted to become the second leading cause of cancer-related death in the western world by 2030. Patients still have a poor prognosis, and a complete surgical resection provides the only potential for long-term cure of pancreatic ductal adenocarcinoma (PDAC) with a 5-year survival of only around 20%.
In addition, despite all the advances and technical modifications developed during this past decade, pancreatic surgery is still hampered by considerable postoperative morbidity. Postoperative pancreatic fistula (POPF), with a range of incidence between 3-45%, and the infectious complications (IC) that occur in nearly one-third of the patients are still the more frequent and dreadful complications after pancreatic resection. Moreover, in patients submitted to pancreaticoduodenectomy (PD), the constantly growing presence of multidrug-resistant (MDR) bacteria increases the morbidity and mortality rate. Those complications may also limit access to adjuvant chemotherapy and result in higher costs and longer hospitalization.
The high clinical burden of pancreatic surgery, associated with the overall poor outcome of PDAC and worldwide diffusion of antibiotic resistance, suggest the urgent need to enhance our knowledge on new and modifiable risk factors able to affect the surgical, the infectious and the oncological outcomes.
The alteration of the microbiome recently emerged as a contributor to oncogenesis, as a risk factor for postoperative morbidity in many intestinal tract malignancies and as one of the leading causes of colonization by resistant pathogenic bacteria. Recent evidence suggests that the pancreas also harbors its microbiome and in PDAC this is markedly more abundant and with different patterns compared to a normal pancreas in both mice and humans. However, the intestinal and PDAC microbiome have never been compared in humans. Alteration of the microbiome induces an adaptive immune suppression and promotes an inflammatory status. Growing literature evidence shows that the microbiome accounts for local and systemic microenvironment changes. These alterations, characterized by immune suppression and selection of potentially pathogenic bacteria, may lead both to adverse outcomes after surgical treatment and to the overgrowth of multidrug-resistant flora.
Nevertheless, the etiologic relationship between intrapancreatic microbiota and postoperative complications in PDAC patients subjected to surgery has not yet been described.
- Being tested
- Microbiome evaluation
- Medical subject headings
- Communicable Diseases, Pancreatic Neoplasms, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome evaluationDiagnostic test
The oral and rectal microbiome samples will be collected preoperatively. The PDAC tissue from the surgical specimen, the intestinal mucosal tissue from the enteric side of the pancreatic anastomosis, and the bile sample will be collected intraoperatively. On the 30th postoperative day, the oral and rectal samples will be repeated
| Study group | Role | What they receive |
|---|---|---|
| Pancreaticoduodenectomy patients | All patients, affected by a resectable PDAC of the head of the pancreas, visited at the Department of Pancreatic Surgery of Verona, will be enrolled. All the patients must be scheduled for an elective PD. The oral and rectal microbiome samples will be collected preoperatively. The PDAC tissue from the surgical specimen, the intestinal mucosal tissue from the enteric side of the pancreatic anastomosis, and the bile sample will be collected intraoperatively. On the 30th postoperative day, the oral and rectal samples will be repeated. Receives: Diagnostic Test: Microbiome evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome evaluation
Qualitative and quantitative analysis of the pancreatic microbiome in patients with PDAC submitted to pancreaticoduodenectomy, sampling intraoperatively the lesion
Measured: 30th day after surgery
Secondary outcomes (3)
Microbiome samples correlation
Definition of a correlation between the pancreatic microbiome and the oral, bile, and rectal microbiome samples
Measured: 30th day after surgery
Microbiome correlation to surgical outcomes
Definition of a correlation between the pancreatic microbiome and the development of the postoperative complications, particularly pancreatic fistula and infectious complications
Measured: 90th day after surgery
Microbiome long-term evaluation
Identification of potential change in the microbiome after surgical resection, comparing pre and post-surgical oral and rectal samples
Measured: 90th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Feb 2020
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies 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
- 20 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274972
- Sponsor's protocol ID
- 2480CESC
- Acronym
- PANDEMIC
- Status last verified
- Jan 2023
- First submitted
- 17 Feb 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microbiome of Pancreatic Cancer: "PANDEMIC" Study
- ClinicalTrials.gov ID
- NCT04274972
- Acronym / sponsor ID
- PANDEMIC / 2480CESC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Feb 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.
Microbiome in patients affected by pancreatic ductal adenocarcinoma may present specific and identifiable patterns. These variations could affect the surgical outcome and increase the risk of life-threatening infections supported by multidrug-resistant bacteria. The identification of microbial signatures with tumor specificity may have a potential role in postoperative risk stratification. Variation of pancreatic, intestinal or bile microbiome and their relationship can be investigated and measured as promising tools in order to predict and overcome the clinical and infectious burden imposed by MDR infections. The prospect of a potential role for probiotics to promote competition against the pathogens and to improve the gastrointestinal barrier integrity has also been raised. Moreover, if the bacterial composition in human PDAC was confirmed to be distinct from that of the normal pancreas, microbiome variation could be used as a potential biomarker, to assess the potential for malignancy in precursor neoplastic lesions. However, we believe that a preliminary and explorative study is necessary. The study aims to outline the pancreatic microbiome of patients who undergo upfront PD for resectable PDAC and to characterize the possible association between bacterial composition and the occurrence of post-operative complications, particularly POPF and IC.
Detailed description
Pancreatic cancer is predicted to become the second leading cause of cancer-related death in the western world by 2030. Patients still have a poor prognosis, and a complete surgical resection provides the only potential for long-term cure of pancreatic ductal adenocarcinoma (PDAC) with a 5-year survival of only around 20%.
In addition, despite all the advances and technical modifications developed during this past decade, pancreatic surgery is still hampered by considerable postoperative morbidity. Postoperative pancreatic fistula (POPF), with a range of incidence between 3-45%, and the infectious complications (IC) that occur in nearly one-third of the patients are still the more frequent and dreadful complications after pancreatic resection. Moreover, in patients submitted to pancreaticoduodenectomy (PD), the constantly growing presence of multidrug-resistant (MDR) bacteria increases the morbidity and mortality rate. Those complications may also limit access to adjuvant chemotherapy and result in higher costs and longer hospitalization.
The high clinical burden of pancreatic surgery, associated with the overall poor outcome of PDAC and worldwide diffusion of antibiotic resistance, suggest the urgent need to enhance our knowledge on new and modifiable risk factors able to affect the surgical, the infectious and the oncological outcomes.
The alteration of the microbiome recently emerged as a contributor to oncogenesis, as a risk factor for postoperative morbidity in many intestinal tract malignancies and as one of the leading causes of colonization by resistant pathogenic bacteria. Recent evidence suggests that the pancreas also harbors its microbiome and in PDAC this is markedly more abundant and with different patterns compared to a normal pancreas in both mice and humans. However, the intestinal and PDAC microbiome have never been compared in humans. Alteration of the microbiome induces an adaptive immune suppression and promotes an inflammatory status. Growing literature evidence shows that the microbiome accounts for local and systemic microenvironment changes. These alterations, characterized by immune suppression and selection of potentially pathogenic bacteria, may lead both to adverse outcomes after surgical treatment and to the overgrowth of multidrug-resistant flora.
Nevertheless, the etiologic relationship between intrapancreatic microbiota and postoperative complications in PDAC patients subjected to surgery has not yet been described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreaticoduodenectomy patients | – | Diagnostic Test: Microbiome evaluationAll patients, affected by a resectable PDAC of the head of the pancreas, visited at the Department of Pancreatic Surgery of Verona, will be enrolled. All the patients must be scheduled for an elective PD. The oral and rectal microbiome samples will be collected preoperatively. The PDAC tissue from the surgical specimen, the intestinal mucosal tissue from the enteric side of the pancreatic anastomosis, and the bile sample will be collected intraoperatively. On the 30th postoperative day, the oral and rectal samples will be repeated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients, affected by a resectable PDAC of the head of the pancreas, visited at the Department of Pancreatic Surgery of Verona, will be enrolled. All the patients must be scheduled for an elective PD. The patients will be submitted to the routinely diagnostic preoperative work-up.
Key inclusion criteria (6 listed)
- age between 18 and 65 years;
- PDAC lesion of the pancreatic head confirmed by preoperative histology or cytology;
- Scheduled for elective PD;
- ASA score < 4
- The ability of the subject to understand the character and individual consequences of the clinical trial
Key exclusion criteria (9 listed)
- Patients with a degenerated pancreatic cyst lesion
- Neoadjuvant treatment (both radio and chemotherapy)
- Other current malignancies
- Antibiotic therapy during 4 weeks before surgery
- History of gastrointestinal tract resections or chronic gastrointestinal diseases
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 |
|---|---|---|
| Microbiome evaluationThe oral and rectal microbiome samples will be collected preoperatively. The PDAC tissue from the surgical specimen, the intestinal mucosal tissue from the enteric side of the pancreatic anastomosis, and the bile sample will be collected intraoperatively. On the 30th postoperative day, the oral and rectal samples will be repeated | Diagnostic test | Pancreaticoduodenectomy patients |
Primary outcome
Microbiome evaluation
Time frame: 30th day after surgery
Qualitative and quantitative analysis of the pancreatic microbiome in patients with PDAC submitted to pancreaticoduodenectomy, sampling intraoperatively the lesion
3 secondary outcomes
Microbiome samples correlation
Time frame: 30th day after surgery
Microbiome correlation to surgical outcomes
Time frame: 90th day after surgery
Microbiome long-term evaluation
Time frame: 90th day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Microbial Colonization and Pancreas Cancer, run by Azienda Ospedaliera Universitaria Integrata Verona 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 9 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 17 Jan 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome evaluation (time frame: 30th day after surgery). 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 17 Jan 2023.