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.
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.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Qiaofei Liu, MD
Qiaofei Liu, MD
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.
- Conditions
- Serum Biomarker, Pancreatic Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Pancreatic cancer | All 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 neoplasms | IPMN, MCN, PNEN, and SPN Receives: Diagnostic Test: serum test | |
| Pancreatitis | acute, chronic, and auto-immune pancreatitis Receives: Diagnostic Test: serum test | |
| Auto-immune diseases | SLE, RA, et al Receives: Diagnostic Test: serum test | |
| Pancreatic-biliary infections | cholecystitis, 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.
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.
- First posted12 Aug 2022
- Study start1 May 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Serum BiomarkerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiaofei Liu, Peking Union Medical College Hospital
- Investigators
- Qiaofei Liu, MD, Study chair, Peking Union Medical College Hospital
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 34168659Zhang 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic and Survival Predictive Value of Peripheral Serum Soluble CD58 (sCD5858) in Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT05500027
- Acronym / sponsor ID
- JS-2954
- Conditions
- Serum Biomarker, Pancreatic Cancer
- Keywords
- CD58, TGFβ1, Serum biomaker, Pancreatic cancer, Early dection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cancer | – | Diagnostic Test: serum testAll TNM stages of pancreatic cancer, before/after surgery, before/after chemotherapy, before/after bile drainage |
| Low malignant grade of pancreatic neoplasms | – | Diagnostic Test: serum testIPMN, MCN, PNEN, and SPN |
| Pancreatitis | – | Diagnostic Test: serum testacute, chronic, and auto-immune pancreatitis |
| Auto-immune diseases | – | Diagnostic Test: serum testSLE, RA, et al |
| Pancreatic-biliary infections | – | Diagnostic Test: serum testcholecystitis, cholangitis, et al |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal to participate
- Age less than 18-year old and over 85-year old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum testserum test of sCD58 and TGFbeta1 | Diagnostic test | Auto-immune diseases, Low malignant grade of pancreatic neoplasms, Pancreatic cancer, Pancreatic-biliary infections, Pancreatitis |
Primary outcome
Differentiation expression of serum sCD58 and TGfbeta1 among pancreatic cancer and other conditions
Time frame: 4 years
Serum sCD58 and TGFbeta1, alone or in combination with CA19-9, has diagnostic and survival predictive value for pancreatic cancer patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Background: PubMed 34168659Zhang 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.
- Results publication: PubMed 34193136Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiaofei Liu, MD study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
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.