MicrobiomeNCT06659237
Fecal and Oral Microbiota Between Pancreatic Cancer and Benign/Low-grade Malignant Tumor Patients
An observational study of Microbiome and Pancreatic Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Significant gaps exist in understanding the gastrointestinal microbiota in patients with pancreatic cancer (PCA) versus benign or low-grade malignant pancreatic tumors (NPCA). This study aimed to analyze these microbiota characteristics and explore their potential use in distinguishing malignant pancreatic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microbiome, Pancreatic Neoplasms, 16s RRNA
- What is being tested?
- 16s rRNA or shotgun metagenomics
- Type of treatment
- Pill or oral medicine
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 30 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a pancreatic tumor detected via imaging
Who may be able to join
- Patients with a pancreatic tumor detected via imaging with no prior treatment before sample collection
- Patients volunteer to provide oral and fecal samples
Who cannot join
- Current or previous diagnoses of (a) other malignancies, (b) infectious diseases, (c) oral or gastrointestinal disorders (d) psychiatric or neurodegenerative disorders
- Specific medical procedures or interventions within defined periods, including (a) antibiotic, hormone therapy, or immunosuppressant within the past three months, (b) gastrointestinal reconstructive surgery within the past three months, (c) frequent use of cathartics, antidiarrheals, or therapeutic doses of probiotics within the past month, (d) oral or gastrointestinal examinations within the past three days
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Peking Union Medical College Hospital (PUMCH)
Beijing, Beijing Municipality
About this study
Significant gaps exist in understanding the gastrointestinal microbiota in patients with pancreatic cancer (PCA) versus benign or low-grade malignant pancreatic tumors (NPCA). This study aimed to analyze these microbiota characteristics and explore their potential use in distinguishing malignant pancreatic lesions.
Read the detailed description
In the past decade, microbiome research has rapidly progressed, revealing the critical roles of fecal and oral microbiota in maintaining internal homeostasis. Studies employing 16S rRNA and metagenomics have highlighted dysbiosis of the fecal and oral microbiota as closely linked to PCA development and progression. However, significant gaps exist in understanding the fecal and oral microbiota in patients with pancreatic cancer (PCA) versus benign or low-grade malignant pancreatic tumors (NPCA). This study aimed to analyze fecal and oral microbiota characteristics, and to establish classifiers to discriminate PCA from NPCA, providing a reference for early clinical identification of malignant tumors.
- Conditions
- Microbiome, Pancreatic Neoplasms, 16s RRNA
- Being tested
- 16s rRNA or shotgun metagenomics
- Keywords
- fecal microbiome, oral microbiome, pancreatic neoplasms, 16s rRNA
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16s rRNA or shotgun metagenomicsDiagnostic test
16s rRNA or shotgun metagenomics on oral and fecal samples
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic cancer | Patients pathologically diagnosed with cancer or high-grade mucinous tumors based on surgical specimens or puncture samples Receives: Diagnostic Test: 16s rRNA or shotgun metagenomics | |
| Benign or low-grade malignant pancreatic tumor | Patients with pathological diagnoses such as low-grade intraductal papillary mucinous neoplasm (IPMN), mucinous cystadenoma, serous cystadenoma, chronic pancreatitis, neuroendocrine tumors, or solid pseudopapillary tumors Receives: Diagnostic Test: 16s rRNA or shotgun metagenomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
the accuracy of the diagnostic classifier
we used random forest algorithm to construct oral and fecal microbiome classifiers to discriminate PCA and NPCA. AUC value was used to evaluate the efficacy of the classifiers
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Nov 2020
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiomeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Menghua Dai, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659237
- Sponsor's protocol ID
- PUMCH-PCAMICROBE-2
- Status last verified
- May 2024
- First submitted
- 21 Oct 2024
- Last updated
- 26 Oct 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal and Oral Microbiota Between Pancreatic Cancer and Benign/Low-grade Malignant Tumor Patients
- ClinicalTrials.gov ID
- NCT06659237
- Acronym / sponsor ID
- PUMCH-PCAMICROBE-2
- Conditions
- Microbiome, Pancreatic Neoplasms, 16s RRNA
- Keywords
- fecal microbiome, oral microbiome, pancreatic neoplasms, 16s rRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 26 Oct 2024 (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.
Significant gaps exist in understanding the gastrointestinal microbiota in patients with pancreatic cancer (PCA) versus benign or low-grade malignant pancreatic tumors (NPCA). This study aimed to analyze these microbiota characteristics and explore their potential use in distinguishing malignant pancreatic lesions.
Detailed description
In the past decade, microbiome research has rapidly progressed, revealing the critical roles of fecal and oral microbiota in maintaining internal homeostasis. Studies employing 16S rRNA and metagenomics have highlighted dysbiosis of the fecal and oral microbiota as closely linked to PCA development and progression. However, significant gaps exist in understanding the fecal and oral microbiota in patients with pancreatic cancer (PCA) versus benign or low-grade malignant pancreatic tumors (NPCA). This study aimed to analyze fecal and oral microbiota characteristics, and to establish classifiers to discriminate PCA from NPCA, providing a reference for early clinical identification of malignant tumors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cancer | – | Diagnostic Test: 16s rRNA or shotgun metagenomicsPatients pathologically diagnosed with cancer or high-grade mucinous tumors based on surgical specimens or puncture samples |
| Benign or low-grade malignant pancreatic tumor | – | Diagnostic Test: 16s rRNA or shotgun metagenomicsPatients with pathological diagnoses such as low-grade intraductal papillary mucinous neoplasm (IPMN), mucinous cystadenoma, serous cystadenoma, chronic pancreatitis, neuroendocrine tumors, or solid pseudopapillary tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a pancreatic tumor detected via imaging
Key inclusion criteria (2 listed)
- Patients with a pancreatic tumor detected via imaging with no prior treatment before sample collection
- Patients volunteer to provide oral and fecal samples
Key exclusion criteria (2 listed)
- Current or previous diagnoses of (a) other malignancies, (b) infectious diseases, (c) oral or gastrointestinal disorders (d) psychiatric or neurodegenerative disorders
- Specific medical procedures or interventions within defined periods, including (a) antibiotic, hormone therapy, or immunosuppressant within the past three months, (b) gastrointestinal reconstructive surgery within the past three months, (c) frequent use of cathartics, antidiarrheals, or therapeutic doses of probiotics within the past month, (d) oral or gastrointestinal examinations within the past three days
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 or shotgun metagenomics16s rRNA or shotgun metagenomics on oral and fecal samples | Diagnostic test | Benign or low-grade malignant pancreatic tumor, Pancreatic cancer |
Primary outcome
the accuracy of the diagnostic classifier
Time frame: From enrollment to the end of treatment at 8 weeks
we used random forest algorithm to construct oral and fecal microbiome classifiers to discriminate PCA and NPCA. AUC value was used to evaluate the efficacy of the classifiers
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 26 Oct 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.
Menghua Dai, MD study chair
Peking Union Medical College Hospital
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 Microbiome and Pancreatic Neoplasms, run by Peking Union Medical College Hospital 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 2 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: finished, as of the sponsor's last update on 26 Oct 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 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 accuracy of the diagnostic classifier (time frame: From enrollment to the end of treatment at 8 weeks). 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 26 Oct 2024.