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Not yet recruitingNCT05621824Updated Apr 9, 2024

A Cohort Study on Screening and Follow-up of High-risk Population of PDAC Based on EUS

An observational study in Carcinoma, Pancreatic Ductal, sponsored by Peking Union Medical College Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by Peking Union Medical College Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
900
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

I. 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.

V. 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.

02

Conditions studied

  • Carcinoma, Pancreatic Ductal

Keywords

  • Early Pancreatic Ductal Adenocarcinoma
  • Endoscopic Ultrasound
  • HighRisks for Pancreatic Ductal Adenocarcinoma
03

In context

Carcinoma, Pancreatic Ductal

50 studies on the registry are indexed under Carcinoma, Pancreatic Ductal; 9 are open to participants now.

Browse Carcinoma, Pancreatic Ductal studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with high risks for pancreas cancer in Peking Union Medical College Hospital and other related research centers in China.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
900 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Solid mass

    Patients with solid mass of pancreas during pancreas MR examination.

    Device: Endoscopic ultrasound · Procedure: EUS-Fine needle aspiration

  • Cystic lesions

    Patients with cystic lesions or expansion of MPD during pancreas MR examination.

    Device: Endoscopic ultrasound · Procedure: EUS-Fine needle aspiration

  • No clear focus

    Patients with no clear focus during pancreas MR examination.

Interventions

  • DeviceEndoscopic ultrasound

    Use endoscopic ultrasound to examine the pancreatic lesions.

  • ProcedureEUS-Fine needle aspiration

    If solid mass of pancreas was found during EUS, EUS-FNA shall be conducted for diagnosis.

06

What researchers measure

Primary outcomes

  1. Number of Participants with T1 PDAC

    Patients found with early stage PDAC, which means tumor size \< 2cm.

    Time frame: 5 years

  2. Number of Participants with no clear pancreas lesions

    Patients found with no clear pancreas lesions during 5 years follow-up.

    Time frame: 5 years

Secondary outcomes

  1. Number of Participants with other stages of PDAC

    Patients found with any other stages of PDAC except from T1 PDAC.

    Time frame: 5 years

  2. Number of Participants with IPMN

    Patients found with IPMN during the study.

    Time frame: 5 years

  3. Number of Participants with chronic pancreatitis

    Patients found with chronic pancreatitis during the study.

    Time frame: 5 years

  4. Number of Participants with autoimmune pancreatitis

    Patients found with autoimmune pancreatitis during the study.

    Time frame: 5 years

  5. Number of Participants with other pancreas diseases

    Patients found with any other pancreas diseases except from listed above during the study.

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05621824
Lead sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Hospital, Tongji Hospital, The First Affiliated Hospital of Xiamen University
Responsible party
Wu Xi (associate professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Nov 18, 2022
Start date
Dec 2024 (estimated)
Primary completion
Jun 2026 (estimated)
Completion
Dec 2028 (estimated)
Last update
Apr 9, 2024

Study contacts

Xi Wu, M.D.
Contact
wxpumch@163.com
+86 13683296860
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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