Pancreatic Ductal Adenocarcinoma (PDAC)NCT06147154
Microbiota and Metabolites Alterations in Pancreatic Head and Body/Tail Cancer Patients
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC), run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC) can be divided into pancreatic head cancer (PHC) and pancreatic body/tail cancer (PBTC) according to the anatomical position of tumors. There is increasing evidence that tumors at different sites exhibit different genetic or molecular features and clinical manifestations, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- 16S rRNA amplicon sequencing and untargeted metabolomics
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To investigate the microbial and metabolic differences between PHC and PBTC and explore the etiology and development of PHC and PBTC by 16S rRNA amplicon sequencing and untargeted metabolome analysis.
Who may be able to join
- Participants aged above 18 years.
- Patients who signed informed consent.
- PDAC patients diagnosed via postoperative pathology.
Who cannot join
- Comorbidity with other cancers.
- Underwent preoperative chemotherapy, radiotherapy, or other biological treatment.
- Use of antibiotics, probiotics or prebiotics in the previous month.
Trial locations and contacts
1 site in 1 country.
About this study
Pancreatic ductal adenocarcinoma (PDAC) can be divided into pancreatic head cancer (PHC) and pancreatic body/tail cancer (PBTC) according to the anatomical position of tumors. There is increasing evidence that tumors at different sites exhibit different genetic or molecular features and clinical manifestations, and can affect the survival and outcomes of PDAC patients. Studies have shown that the prognosis of PBTC is worse than that of PHC, which is partly attributed to the relatively late clinical presentation of PBTC patients and the lack of overt symptoms such as obstructive jaundice, which is common in PHC. However, it has also been shown that the worse survival of PBTC compared to PHC is not related to the disease stage. Previous studies have investigated the molecular differences between PHC and PBTC and found that the frequency of SMAD4 mutation in PBTC was significantly higher than that in PHC at early stages (I-II). In the late stage (III-IV), PBTC had higher mutation frequency of Kirsten rat sarcoma viral oncogene homolog (KRAS) and mitogen-activated protein kinase (MAPK) pathway, but lower frequency of genomic alterations which can be targeted by drugs. The above genetic and molecular differences may be related to the clinical differences between PHC and PBTC.
However, the differences in microbial composition and metabolism between PHC and PBTC have not been fully studied and discussed, and their relationship with clinical manifestations and prognosis is also unclear. In this study, the investigators aimed to analyze the microbial and metabolic differences between PHC and PBTC through 16S ribosomal ribonucleic acid (rRNA) sequencing and untargeted metabolome analysis to further explore the etiology and pathogenesis of PDAC at different anatomical positions.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- 16S rRNA amplicon sequencing and untargeted metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16S rRNA amplicon sequencing and untargeted metabolomicsOther
16S rRNA sequencing is a method for large-scale identification of community composition, expression abundance, and phylogenetic analysis by polymerase chain reaction (PCR) amplification of specific variable regions of 16S rRNA, combined with high-throughput sequencing and bioinformatics analysis. It also enables large-scale identification of the entire flora in a given habitat to study microbial diversity.
Untargeted metabolomics refers to the use of Liquid Chromatograph Mass Spectrometer (LC-MS), Gas Chromatograph Mass Spectrometer (GC-MS), and nuclear magnetic resonance (NMR) technology. The dynamic changes of small molecular metabolites in cells, tissues, organs or organisms before and after stimulation or disturbance were detected without bias. The differential metabolites were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the physiological mechanism of their changes.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic head cancer (PHC) tumor tissues | Not described Receives: Other: 16S rRNA amplicon sequencing and untargeted metabolomics | |
| Pancreatic head cancer (PHC) matched non-tumor tissues | Not described Receives: Other: 16S rRNA amplicon sequencing and untargeted metabolomics | |
| Pancreatic body/tail cancer (PBTC) tumor tissues | Not described Receives: Other: 16S rRNA amplicon sequencing and untargeted metabolomics | |
| Pancreatic body/tail cancer (PBTC) matched non-tumor tissues | Not described Receives: Other: 16S rRNA amplicon sequencing and untargeted metabolomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
the abundance of changed microorganisms of PHC and PBTC
Detect the categories and quantities of microorganisms significantly enriched and decreased in the case group.
Measured: 2023-11-20 to 2023-12-20
the abundance of changed metabolites of PHC and PBTC
Detect the categories and quantities of metabolites significantly upregulated or downregulated in the case group.
Measured: 2023-11-20 to 2023-12-20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147154
- Sponsor's protocol ID
- 2023SDU-QILU-5
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota and Metabolites Alterations in Pancreatic Head and Body/Tail Cancer Patients
- ClinicalTrials.gov ID
- NCT06147154
- Acronym / sponsor ID
- 2023SDU-QILU-5
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Nov 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.
Pancreatic ductal adenocarcinoma (PDAC) can be divided into pancreatic head cancer (PHC) and pancreatic body/tail cancer (PBTC) according to the anatomical position of tumors. There is increasing evidence that tumors at different sites exhibit different genetic or molecular features and clinical manifestations, and can affect the survival and outcomes of PDAC patients. Studies have shown that the prognosis of PBTC is worse than that of PHC, which is partly attributed to the relatively late clinical presentation of PBTC patients and the lack of overt symptoms such as obstructive jaundice, which is common in PHC. However, it has also been shown that the worse survival of PBTC compared to PHC is not related to the disease stage. Previous studies have investigated the molecular differences between PHC and PBTC and found that the frequency of SMAD4 mutation in PBTC was significantly higher than that in PHC at early stages (I-II). In the late stage (III-IV), PBTC had higher mutation frequency of Kirsten rat sarcoma viral oncogene homolog (KRAS) and mitogen-activated protein kinase (MAPK) pathway, but lower frequency of genomic alterations which can be targeted by drugs. The above genetic and molecular differences may be related to the clinical differences between PHC and PBTC.
However, the differences in microbial composition and metabolism between PHC and PBTC have not been fully studied and discussed, and their relationship with clinical manifestations and prognosis is also unclear. In this study, the investigators aimed to analyze the microbial and metabolic differences between PHC and PBTC through 16S ribosomal ribonucleic acid (rRNA) sequencing and untargeted metabolome analysis to further explore the etiology and pathogenesis of PDAC at different anatomical positions.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pancreatic head cancer (PHC) tumor tissues | – | Other: 16S rRNA amplicon sequencing and untargeted metabolomics |
| Pancreatic head cancer (PHC) matched non-tumor tissues | – | Other: 16S rRNA amplicon sequencing and untargeted metabolomics |
| Pancreatic body/tail cancer (PBTC) tumor tissues | – | Other: 16S rRNA amplicon sequencing and untargeted metabolomics |
| Pancreatic body/tail cancer (PBTC) matched non-tumor tissues | – | Other: 16S rRNA amplicon sequencing and untargeted metabolomics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To investigate the microbial and metabolic differences between PHC and PBTC and explore the etiology and development of PHC and PBTC by 16S rRNA amplicon sequencing and untargeted metabolome analysis.
Key inclusion criteria (3 listed)
- Participants aged above 18 years.
- Patients who signed informed consent.
- PDAC patients diagnosed via postoperative pathology.
Key exclusion criteria (3 listed)
- Comorbidity with other cancers.
- Underwent preoperative chemotherapy, radiotherapy, or other biological treatment.
- Use of antibiotics, probiotics or prebiotics in the previous month.
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 |
|---|---|---|
| 16S rRNA amplicon sequencing and untargeted metabolomics16S rRNA sequencing is a method for large-scale identification of community composition, expression abundance, and phylogenetic analysis by polymerase chain reaction (PCR) amplification of specific variable regions of 16S rRNA, combined with high-throughput sequencing and bioinformatics analysis. It also enables large-scale identification of the entire flora in a given habitat to study microbial diversity. Untargeted metabolomics refers to the use of Liquid Chromatograph Mass Spectrometer (LC-MS), Gas Chromatograph Mass Spectrometer (GC-MS), and nuclear magnetic resonance (NMR) technology. The dynamic changes of small molecular metabolites in cells, tissues, organs or organisms before and after stimulation or disturbance were detected without bias. The differential metabolites were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the physiological mechanism of their changes. | Other | Pancreatic body/tail cancer (PBTC) matched non-tumor tissues, Pancreatic body/tail cancer (PBTC) tumor tissues, Pancreatic head cancer (PHC) matched non-tumor tissues, Pancreatic head cancer (PHC) tumor tissues |
Primary outcome
the abundance of changed microorganisms of PHC and PBTC
Time frame: 2023-11-20 to 2023-12-20
Detect the categories and quantities of microorganisms significantly enriched and decreased in the case group.
the abundance of changed metabolites of PHC and PBTC
Time frame: 2023-11-20 to 2023-12-20
Detect the categories and quantities of metabolites significantly upregulated or downregulated in the case group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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RecruitingPhase 3
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RecruitingPhase 2
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RecruitingPhase 3
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreatic Ductal Adenocarcinoma (PDAC), run by Qilu Hospital of Shandong University at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 30 Nov 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the abundance of changed microorganisms of PHC and PBTC (time frame: 2023-11-20 to 2023-12-20). 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 30 Nov 2023.