sCD8, as a Novel Biomarker for Pancreatic Cancer
The Diagnostic and Survival Predictive Value of Peripheral Serum Soluble CD58 (sCD5858) in Pancreatic Cancer Patients
1 other identifier
observational
2,000
1 country
1
Brief Summary
Early detection and early treatment is the most important issue to improve the long-term survival of pancreatic cancer patients. CA199 is the most commonly used biomarker for early detection and to predict survival, however, the overall positive rate for CA199 is only 75%, and what is worse, for the early stage of pancreatic cancer patients, the positive rate is even lower, and for the lewis negative patients, CA199 is not produced at all. Therefore, novel biomarkers for the early detection of pancreatic cancer are still urgently needed. Previously, we found there is a vicious cycle between pancreatic cancer cells, that is pancreatic cancer-produced TGFbeta1 could promote the production of soluble CD58 (sCD58) in macrophages, and then sCD58 could induce the production of TGFbeta1 in pancreatic cancer cells. Therefore, the serum level of TGFbeta1 and sCD58 has diagnostic and survival values for pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 7, 2022
CompletedFirst Posted
Study publicly available on registry
August 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedAugust 12, 2022
August 1, 2022
3.6 years
August 7, 2022
August 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differentiation expression of serum sCD58 and TGfbeta1 among pancreatic cancer and other conditions
Serum sCD58 and TGFbeta1, alone or in combination with CA19-9, has diagnostic and survival predictive value for pancreatic cancer patients
4 years
Study Arms (5)
Pancreatic cancer
All TNM stages of pancreatic cancer, before/after surgery, before/after chemotherapy, before/after bile drainage
Low malignant grade of pancreatic neoplasms
IPMN, MCN, PNEN, and SPN
Pancreatitis
acute, chronic, and auto-immune pancreatitis
Auto-immune diseases
SLE, RA, et al
Pancreatic-biliary infections
cholecystitis, cholangitis, et al
Interventions
serum test of sCD58 and TGFbeta1
Eligibility Criteria
A pathological diagnosis should be obtained for cancer patients. In addition, the other non-neoplastic disease patients should reach the diagnostic criteria recommended by the related guidelines.
You may qualify if:
- Healthy volunteers
- Stage I-IV pancreatic cancer patients with pathological diagnosis
- Pancreatic cancer patients before and 1 week after surgery
- Pancreatic cancer patients before and 1 week after bile drainage
- IPMN patients with pathological diagnosis before and 1 week after surgery
- MCN patients with pathological diagnosis before and 1 week after surgery
- SPN patients with pathological diagnosis before and 1 week after surgery
- PNEN patients with pathological diagnosis before and 1 week after surgery
- Chronic pancreatitis patients with pathological diagnosis
- Cholecystitis patients meeting clinical criteria
- Cholangitis patients meeting clinical criteria
- Autoimmune diseases meeting clinical criteria
You may not qualify if:
- Refusal to participate
- Age less than 18-year old and over 85-year old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (2)
Zhang Y, Liu Q, Yang S, Liao Q. CD58 Immunobiology at a Glance. Front Immunol. 2021 Jun 8;12:705260. doi: 10.3389/fimmu.2021.705260. eCollection 2021.
PMID: 34168659BACKGROUNDZhang Y, Liu Q, Liu J, Liao Q. Upregulated CD58 is associated with clinicopathological characteristics and poor prognosis of patients with pancreatic ductal adenocarcinoma. Cancer Cell Int. 2021 Jun 30;21(1):327. doi: 10.1186/s12935-021-02037-0.
PMID: 34193136RESULT
Biospecimen
Peripheral serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Qiaofei Liu, MD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of General Surgery
Study Record Dates
First Submitted
August 7, 2022
First Posted
August 12, 2022
Study Start
May 1, 2021
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
August 12, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share