AzTrials
AzTrials

Serum BiomarkerNCT05500027

sCD8, as a Novel Biomarker for Pancreatic Cancer

An observational study of Serum Biomarker and Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Serum Biomarker, Pancreatic Cancer
What is being tested?
serum test
How many people
2,000 participants
Where
1 siteChina
Study dates
1 May 2021to Dec 2025
Phase
Observational
Are there results?
None posted in the registry

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 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • Refusal to participate
  • Age less than 18-year old and over 85-year old

Trial locations and contacts

1 site in 1 country.

Qiaofei Liu, MD contact

15201693370

qfliu@aliyun.com

China1 site, 1 recruiting
  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Qiaofei Liu, MD

    Qiaofei Liu, MD

    Recruiting

Other trials in China

About this study

Official title: The Diagnostic and Survival Predictive Value of Peripheral Serum Soluble CD58 (sCD5858) in Pancreatic Cancer Patients

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.

Read the detailed description

Pancreatic cancer is a highly malignant tumor with a very poor prognosis. The five-year survival rate is only 10%, and its incidence is significantly increasing worldwide. Early diagnosis and treatment can improve the survival of pancreatic cancer patients. However, the early diagnosis of pancreatic cancer is extremely difficult, and more than 50% of patients have distant metastasis at the time of diagnosis. Therefore, the development of sensitive and efficient serum biomarkers for pancreatic cancer has important clinical significance. Pancreatic cancer has a special microenvironment. Pancreatic cancer cells are only 10 to 30 percent, while inflammatory cells are more than 50 percent. The interaction between inflammatory cells and tumor cells promotes the development of pancreatic cancer. CD58 is an important immune adhesion molecule, which exists in the membrane (mCD58) and soluble (sCD58) states. For the first time, the investigators found that macrophages can promote CD58 expression separation in pancreatic cancer cells through TGFβ1, that is, the expression of mCD58 decreased and the release of more sCD58. SCD58 competitively binds CD2 on T/NK cells, thereby inducing immune suppression and promoting the development of pancreatic cancer. Therefore, the investigators propose a scientific hypothesis that serum sCD58 and TGFβ1 can be used as markers of tumor burden and tumor immunosuppression status in pancreatic cancer. They have important value in the diagnosis, immunotyping, and prognosis of pancreatic cancer. To test this scientific hypothesis, the investigators obtained peripheral blood serum from 132 healthy controls, 131 patients undergoing pancreatic cancer surgery, 80 patients with low-grade malignant pancreatic tumors, 58 patients with benign pancreatic tumors, and 16 patients with chronic pancreatitis as a training cohort. The expression levels of sCD58 and TGFβ1 in serum were detected by Elisa. The results showed that the expression levels of sCD58 and TGFβ1 in peripheral blood were significantly higher in pancreatic cancer, but there was no significant difference in sCD58 and TGFβ1 between other pancreatic diseases and healthy people. The expression levels of sCD58 and TGFβ1 were positively correlated with the clinical stage of pancreatic cancer. The level of sCD58 is negatively correlated with the prognosis of pancreatic cancer patients. The three-factor diagnostic model of sCD58, TGFβ1 and CA199 can improve the diagnostic efficiency of pancreatic cancer, especially when CA199 is disabled, sCD58 and TGFβ1 still have high diagnostic efficiency. However, this previous study still had the following shortcomings :(1) patients with advanced pancreatic cancer were not included; (2) The relationship between serum sCD58 and TGFβ1 and the efficacy of chemotherapy was not clarified. (3) The effects of immune diseases and infection on serum sCD58 and TGFβ1 were not considered; (4) The included sample size is small. Based on the previous study, this study plans to expand the sample size by 2 times as the validation cohort. The clinical value of serum sCD58 and TGFβ1 as biomarkers for diagnosis, immunotyping and prognosis prediction of pancreatic cancer was fully clarified by using pre-mature detection methods and modeling methods to improve the above four deficiencies. To develop a kit combining sCD58, TGFβ1 and CA199, improve the early diagnosis and treatment rate of pancreatic cancer, guide accurate immune typing and optimize individualized treatment, and finally prolong the survival time of patients.

Being tested
serum test
Keywords
CD58, TGFβ1, Serum biomaker, Pancreatic cancer, Early dection
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • serum testDiagnostic test

    serum test of sCD58 and TGFbeta1

Study groups in NCT05500027
Study groupRoleWhat they receive
Pancreatic cancerAll TNM stages of pancreatic cancer, before/after surgery, before/after chemotherapy, before/after bile drainage
Receives: Diagnostic Test: serum test
Low malignant grade of pancreatic neoplasmsIPMN, MCN, PNEN, and SPN
Receives: Diagnostic Test: serum test
Pancreatitisacute, chronic, and auto-immune pancreatitis
Receives: Diagnostic Test: serum test
Auto-immune diseasesSLE, RA, et al
Receives: Diagnostic Test: serum test
Pancreatic-biliary infectionscholecystitis, cholangitis, et al
Receives: Diagnostic Test: serum test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2022
  2. Study start1 May 2021
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05500027
Sponsor's protocol ID
JS-2954
Status last verified
Aug 2022
First submitted
7 Aug 2022
Last updated
12 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34168659
  • Zhang 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.

    PubMed 34193136

Questions about this trial

What is this clinical trial studying?

An observational study of Serum Biomarker and Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.

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 12 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: status not confirmed, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qiaofei Liu, MD (15201693370, qfliu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differentiation expression of serum sCD58 and TGfbeta1 among pancreatic cancer and other conditions (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05500027, which also lists 2 linked publications.

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 12 Aug 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in