Pancreatic CancerNCT05689138
Using Digestive Microbial Information to Enhance the Early Detection of Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Pancreatic cancer (PCA) is a leading death-related cancer. There is an urgent need for accurate, noninvasive diagnostic options in the early detection of pancreatic cancer (PCA), since delayed diagnosis increases the risk of metastasis and recurrence. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Oral and Fecal Sample Collection
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Dec 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Present/ past diagnosis of (a) other malignancy, (b) infectious diseases, (c) oral or digestive diseases, (d) mental psychiatric or neurodegenerative diseases, (e) chronic diseases that may affect the organ function; Have received certain medical examinations or interventions within specific periods, including (a) antibiotics, hormonotherapy, or immunosuppressor in the past three months, (b) digestive tract reconstructive operation in the past three months, (c) Frequent use of a cathartic, antidiarrheal, or therapeutic dose of probiotics throughout the past one month, (d) Change of diet throughout the past one month, (e) local antibiotics usage in 1 week(skin, antibacterial mouth wash) (f) oral or digestive examination in 3 days.
Who may be able to join
- PCA Newly diagnosed pancreatic cancer patients; No symptoms of jaundice; Did not yet receive any treatment
- NC Individuals who were undergoing routine screenings or physical examination
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SCREENING ORAL AND GUT MICROBES AS A MORE ACCURATE NON-INVASIVE TOOL FOR PANCREATIC CANCER EARLY DETECTION: A POPULATION-BASED CASE-CONTROL STUDY IN CHINA
Pancreatic cancer (PCA) is a leading death-related cancer. There is an urgent need for accurate, noninvasive diagnostic options in the early detection of pancreatic cancer (PCA), since delayed diagnosis increases the risk of metastasis and recurrence. In this study, by analyzing gut and fecal microbial data among the pancreatic versus healthy populations, we aim to establish an early detection tool to improve PCA detection, and to explore potential diagnostic biomarkers.
- Conditions
- Pancreatic Cancer
- Being tested
- Oral and Fecal Sample Collection
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral and Fecal Sample CollectionOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| PCA | pancreatic cancer patients Receives: Other: Oral and Fecal Sample Collection | |
| NC | normal control Receives: Other: Oral and Fecal Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbial features by 16s rRNA sequencing
Measured: within 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Sep 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai Menghua, Peking Union Medical College Hospital
- Investigators
- Menghua Dai, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689138
- Sponsor's protocol ID
- PUMCH-PCAMicrobe-1
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCREENING ORAL AND GUT MICROBES AS A MORE ACCURATE NON-INVASIVE TOOL FOR PANCREATIC CANCER EARLY DETECTION: A POPULATION-BASED CASE-CONTROL STUDY IN CHINA
- ClinicalTrials.gov ID
- NCT05689138
- Acronym / sponsor ID
- PUMCH-PCAMicrobe-1
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 18 Jan 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 cancer (PCA) is a leading death-related cancer. There is an urgent need for accurate, noninvasive diagnostic options in the early detection of pancreatic cancer (PCA), since delayed diagnosis increases the risk of metastasis and recurrence. In this study, by analyzing gut and fecal microbial data among the pancreatic versus healthy populations, we aim to establish an early detection tool to improve PCA detection, and to explore potential diagnostic biomarkers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCA | – | Other: Oral and Fecal Sample Collectionpancreatic cancer patients |
| NC | – | Other: Oral and Fecal Sample Collectionnormal control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Present/ past diagnosis of (a) other malignancy, (b) infectious diseases, (c) oral or digestive diseases, (d) mental psychiatric or neurodegenerative diseases, (e) chronic diseases that may affect the organ function; Have received certain medical examinations or interventions within specific periods, including (a) antibiotics, hormonotherapy, or immunosuppressor in the past three months, (b) digestive tract reconstructive operation in the past three months, (c) Frequent use of a cathartic, antidiarrheal, or therapeutic dose of probiotics throughout the past one month, (d) Change of diet throughout the past one month, (e) local antibiotics usage in 1 week(skin, antibacterial mouth wash) (f) oral or digestive examination in 3 days.
Key inclusion criteria (2 listed)
- PCA Newly diagnosed pancreatic cancer patients; No symptoms of jaundice; Did not yet receive any treatment
- NC Individuals who were undergoing routine screenings or physical examination
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Oral and Fecal Sample CollectionNo interventions | Other | NC, PCA |
Primary outcome
microbial features by 16s rRNA sequencing
Time frame: within 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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.
Menghua Dai, MD principal investigator
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 Pancreatic Cancer, 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 0 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 18 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 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?
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?
microbial features by 16s rRNA sequencing (time frame: within 180 days). 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 18 Jan 2023.