Carcinoma, Pancreatic DuctalNCT05621824
A Cohort Study on Screening and Follow-up of High-risk Population of PDAC Based on EUS
An observational study of Carcinoma, Pancreatic Ductal, run by Peking Union Medical College Hospital.
Trial summary
Study objective: The purpose of this study is to establish a prospective follow-up cohort of high-risk groups of pancreatic cancer, screen early pancreatic cancer through EUS and other means according to the existing clinical process, and evaluate each risk factors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Pancreatic Ductal
- What is being tested?
- Endoscopic ultrasound and EUS-Fine needle aspiration
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with high risks for pancreas cancer in Peking Union Medical College Hospital and other related research centers in China.
Who may be able to join
- From the beginning of the study to the end of the study, the 18-80 year old patients who were admitted to Peking Union Medical College Hospital and related research centers and who met the high-risk population of pancreatic cancer understood and were willing to participate in the study and signed the informed consent form.
- In this study, the high-risk population of pancreatic cancer is defined as patients who meet any of the following conditions:
- A. Patients with previous history of pancreatitis (acute or chronic).
- B. Patients with pancreatic cancer related genetic background, including immediate relatives with a family history of pancreatic cancer. Or genetic syndrome related to pancreatic cancer. [including hereditary breast cancer ovarian cancer syndrome (HBOCS), carney complex (CNC), familial adenomatous polyps (FAP), hereditary diffuse gastric cancer syndrome (HDGC), juvenile polyposis (JPS), cutaneous malignant melanoma (CMM), hereditary papillary renal cell carcinoma (HPRCC) and Lynch syndrome]
- C. Patients with continuous or progressive increase of CA19-9 and CEA.
- D. Patients with potential malignant pancreatic tumors, including mucinous cystic tumor (MCN) and intraductal papillary myxoma of the pancreas (IPMN).
- E. Newly diagnosed patients with diabetes (within 3 years after diagnosis of diabetes).
- F. Other patients who are considered as having high risk factors for pancreatic cancer.
Who cannot join
- A. Those who are not suitable for endoscopic examination, including but not limited to: poor general condition, serious heart and lung disease, and difficult to tolerate the examination; coagulation disorders; platelets <50 × 10^9/L；those who are not suitable for endoscopic examination after interview by an endoscopic physician.
- B. The patient or family member could not understand the conditions and objectives of this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Cohort Study on Screening and Follow-up of High-risk Population of Pancreatic Cancer Based on Endoscopic Ultrasonography
Study objective: The purpose of this study is to establish a prospective follow-up cohort of high-risk groups of pancreatic cancer, screen early pancreatic cancer through EUS and other means according to the existing clinical process, and evaluate each risk factors. And to prospectively collect biological samples to find molecular markers for early diagnosis of pancreatic cancer.
Study design: This is a real world, multicenter, prospective, observational cohort study.
Read the detailed description
This study intends to conduct pancreatic MR screening for the high-risk population of pancreatic cancer who meet the requirements and voluntarily participate in this study (see eligibility criteria), and retain baseline information and peripheral blood, dental plaque and stool samples.
- For patients with solid mass of the pancreas, continue diagnosis and treatment according to the routine clinical path.
II. For patients with MPD dilatation but no clear solid pancreatic mass, EUS examination should be performed after excluding contraindications. During EUS, duodenal fluid samples were collected.
III. If solid mass is found in EUS, FNA shall be performed. If the pathological examination is positive, the patient shall be diagnosed with PDAC and treated according to the clinical routine path of PDAC. If the pathological biopsy sample is negative, repeat FNA after an appropriate interval (1 to 3 months later).
IV. If no solid mass is found in EUS, follow up the patient every 6-12 months for EUS and/or MR examination.
- For patients with cystic lesions, EUS examination is performed after contraindications are excluded. During EUS, duodenal fluid samples were collected. If solid components such as mural nodules or "worrisome features" are found, FNA will be performed. In order to make a clear diagnosis of some cases, FNA+nCLE will be performed at the same time, and cystic fluid samples will be taken to continue diagnosis and treatment according to the clinical guidelines. If no solid lesions and "worrisome features" are found, follow up the patient every 6-12 months and perform EUS and/or MR examinations.
VI. Follow up and perform pancreatic MR examination every 12 months for those with no clear pancreatic lesions found on pancreatic MR.
The main outcome of this study was the discovery of pancreatic T1 PDAC (tumor diameter < 2cm), or no pancreatic disease was found during the 5-year follow-up period.
The secondary outcome of this study was the discovery of other levels of PDAC, IPMN, chronic pancreatitis, autoimmune pancreatitis and other pancreatic diseases.
The samples involved in this study include baseline and follow-up samples (peripheral blood, dental plaque, stool samples), EUS-FNA solid mass aspiration tissue samples or cystic fluid samples of cystic lesions, and duodenal fluid samples collected during EUS examination. The collected samples were analyzed by transcriptomics, proteomics and next generation sequencing to study the clinical characteristics, molecular, flora markers and gene sequences related to the diagnosis of early pancreatic cancer.
- Conditions
- Carcinoma, Pancreatic Ductal
- Being tested
- Endoscopic ultrasound, EUS-Fine needle aspiration
- Keywords
- Early Pancreatic Ductal Adenocarcinoma, Endoscopic Ultrasound, HighRisks for Pancreatic Ductal Adenocarcinoma
- Medical subject headings
- Carcinoma, Pancreatic Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasoundDevice
Use endoscopic ultrasound to examine the pancreatic lesions.
EUS-Fine needle aspirationProcedure or surgery
If solid mass of pancreas was found during EUS, EUS-FNA shall be conducted for diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Solid mass | Patients with solid mass of pancreas during pancreas MR examination. Receives: Device: Endoscopic ultrasound; Procedure: EUS-Fine needle aspiration | |
| Cystic lesions | Patients with cystic lesions or expansion of MPD during pancreas MR examination. Receives: Device: Endoscopic ultrasound; Procedure: EUS-Fine needle aspiration | |
| No clear focus | Patients with no clear focus during pancreas MR examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with T1 PDAC
Patients found with early stage PDAC, which means tumor size < 2cm.
Measured: 5 years
Number of Participants with no clear pancreas lesions
Patients found with no clear pancreas lesions during 5 years follow-up.
Measured: 5 years
Secondary outcomes (5)
Number of Participants with other stages of PDAC
Patients found with any other stages of PDAC except from T1 PDAC.
Measured: 5 years
Number of Participants with IPMN
Patients found with IPMN during the study.
Measured: 5 years
Number of Participants with chronic pancreatitis
Patients found with chronic pancreatitis during the study.
Measured: 5 years
Number of Participants with autoimmune pancreatitis
Patients found with autoimmune pancreatitis during the study.
Measured: 5 years
Number of Participants with other pancreas diseases
Patients found with any other pancreas diseases except from listed above during the study.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study startDec 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Pancreatic DuctalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Tongji Hospital, The First Affiliated Hospital of Xiamen University
- Responsible party
- Principal investigator, Wu Xi, Peking Union Medical College Hospital
- Investigators
- Xi Wu, M.D., Study director, Peking Union Medical College HospitalShengyu Zhang, M.D., Principal investigator, Peking Union Medical College HospitalYuheng Zhang, MD candidate, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621824
- Sponsor's protocol ID
- K2341
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 2022
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on Screening and Follow-up of High-risk Population of Pancreatic Cancer Based on Endoscopic Ultrasonography
- ClinicalTrials.gov ID
- NCT05621824
- Acronym / sponsor ID
- K2341
- Conditions
- Carcinoma, Pancreatic Ductal
- Keywords
- Early Pancreatic Ductal Adenocarcinoma, Endoscopic Ultrasound, HighRisks for Pancreatic Ductal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, Tongji Hospital, The First Affiliated Hospital of Xiamen University
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Nov 2022 (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.
Study objective: The purpose of this study is to establish a prospective follow-up cohort of high-risk groups of pancreatic cancer, screen early pancreatic cancer through EUS and other means according to the existing clinical process, and evaluate each risk factors. And to prospectively collect biological samples to find molecular markers for early diagnosis of pancreatic cancer.
Study design: This is a real world, multicenter, prospective, observational cohort study.
Detailed description
This study intends to conduct pancreatic MR screening for the high-risk population of pancreatic cancer who meet the requirements and voluntarily participate in this study (see eligibility criteria), and retain baseline information and peripheral blood, dental plaque and stool samples.
- For patients with solid mass of the pancreas, continue diagnosis and treatment according to the routine clinical path.
II. For patients with MPD dilatation but no clear solid pancreatic mass, EUS examination should be performed after excluding contraindications. During EUS, duodenal fluid samples were collected.
III. If solid mass is found in EUS, FNA shall be performed. If the pathological examination is positive, the patient shall be diagnosed with PDAC and treated according to the clinical routine path of PDAC. If the pathological biopsy sample is negative, repeat FNA after an appropriate interval (1 to 3 months later).
IV. If no solid mass is found in EUS, follow up the patient every 6-12 months for EUS and/or MR examination.
- For patients with cystic lesions, EUS examination is performed after contraindications are excluded. During EUS, duodenal fluid samples were collected. If solid components such as mural nodules or "worrisome features" are found, FNA will be performed. In order to make a clear diagnosis of some cases, FNA+nCLE will be performed at the same time, and cystic fluid samples will be taken to continue diagnosis and treatment according to the clinical guidelines. If no solid lesions and "worrisome features" are found, follow up the patient every 6-12 months and perform EUS and/or MR examinations.
VI. Follow up and perform pancreatic MR examination every 12 months for those with no clear pancreatic lesions found on pancreatic MR.
The main outcome of this study was the discovery of pancreatic T1 PDAC (tumor diameter < 2cm), or no pancreatic disease was found during the 5-year follow-up period.
The secondary outcome of this study was the discovery of other levels of PDAC, IPMN, chronic pancreatitis, autoimmune pancreatitis and other pancreatic diseases.
The samples involved in this study include baseline and follow-up samples (peripheral blood, dental plaque, stool samples), EUS-FNA solid mass aspiration tissue samples or cystic fluid samples of cystic lesions, and duodenal fluid samples collected during EUS examination. The collected samples were analyzed by transcriptomics, proteomics and next generation sequencing to study the clinical characteristics, molecular, flora markers and gene sequences related to the diagnosis of early pancreatic cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Solid mass | – | Device: Endoscopic ultrasound, Procedure: EUS-Fine needle aspirationPatients with solid mass of pancreas during pancreas MR examination. |
| Cystic lesions | – | Device: Endoscopic ultrasound, Procedure: EUS-Fine needle aspirationPatients with cystic lesions or expansion of MPD during pancreas MR examination. |
| No clear focus | – | –Patients with no clear focus during pancreas MR examination. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high risks for pancreas cancer in Peking Union Medical College Hospital and other related research centers in China.
Key inclusion criteria (8 listed)
- From the beginning of the study to the end of the study, the 18-80 year old patients who were admitted to Peking Union Medical College Hospital and related research centers and who met the high-risk population of pancreatic cancer understood and were willing to participate in the study and signed the informed consent form.
- In this study, the high-risk population of pancreatic cancer is defined as patients who meet any of the following conditions:
- A. Patients with previous history of pancreatitis (acute or chronic).
- B. Patients with pancreatic cancer related genetic background, including immediate relatives with a family history of pancreatic cancer. Or genetic syndrome related to pancreatic cancer. [including hereditary breast cancer ovarian cancer syndrome (HBOCS), carney complex (CNC), familial adenomatous polyps (FAP), hereditary diffuse gastric cancer syndrome (HDGC), juvenile polyposis (JPS), cutaneous malignant melanoma (CMM), hereditary papillary renal cell carcinoma (HPRCC) and Lynch syndrome]
- C. Patients with continuous or progressive increase of CA19-9 and CEA.
Key exclusion criteria (2 listed)
- A. Those who are not suitable for endoscopic examination, including but not limited to: poor general condition, serious heart and lung disease, and difficult to tolerate the examination; coagulation disorders; platelets <50 × 10^9/L；those who are not suitable for endoscopic examination after interview by an endoscopic physician.
- B. The patient or family member could not understand the conditions and objectives of this study.
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 |
|---|---|---|
| Endoscopic ultrasoundUse endoscopic ultrasound to examine the pancreatic lesions. | Device | Cystic lesions, Solid mass |
| EUS-Fine needle aspirationIf solid mass of pancreas was found during EUS, EUS-FNA shall be conducted for diagnosis. | Procedure or surgery | Cystic lesions, Solid mass |
Primary outcome
Number of Participants with T1 PDAC
Time frame: 5 years
Patients found with early stage PDAC, which means tumor size < 2cm.
Number of Participants with no clear pancreas lesions
Time frame: 5 years
Patients found with no clear pancreas lesions during 5 years follow-up.
5 secondary outcomes
Number of Participants with other stages of PDAC
Time frame: 5 years
Number of Participants with IPMN
Time frame: 5 years
Number of Participants with chronic pancreatitis
Time frame: 5 years
Number of Participants with autoimmune pancreatitis
Time frame: 5 years
Number of Participants with other pancreas diseases
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
Related trials for Carcinoma, Pancreatic Ductal
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
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.
Xi Wu, M.D. study director
Peking Union Medical College Hospital
Shengyu Zhang, M.D. principal investigator
Peking Union Medical College Hospital
Yuheng Zhang, MD candidate principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Pancreatic Ductal, run by Peking Union Medical College Hospital.
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 8 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: opening soon, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xi Wu, M.D. (+86 13683296860, wxpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with T1 PDAC (time frame: 5 years). 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 9 Apr 2024.