Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05621824 |
| Other study ID # |
K2341 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2024 |
| Est. completion date |
December 2028 |
Study information
| Verified date |
April 2024 |
| Source |
Peking Union Medical College Hospital |
| Contact |
Xi Wu, M.D. |
| Phone |
+86 13683296860 |
| Email |
wxpumch[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
