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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endoscopic ultrasound

    Device

    Use endoscopic ultrasound to examine the pancreatic lesions.

  • EUS-Fine needle aspiration

    Procedure/Surgery

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

Treatment groups

900 Participants
are divided into 3 treatment groups
Group A: Solid mass2 interventions
Group B: Cystic lesions2 interventions
Group C: No clear focus0 interventions

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Beijing Hospital

Collaborator

Tongji Hospital

Collaborator

The First Affiliated Hospital of Xiamen University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: