sCD8, as a Novel Biomarker for Pancreatic Cancer

August 11, 2022 updated by: Qiaofei Liu, Peking Union Medical College Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Qiaofei Liu, MD
        • Principal Investigator:
          • Qiaofei Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Pancreatic cancer
All TNM stages of pancreatic cancer, before/after surgery, before/after chemotherapy, before/after bile drainage
Diagnostic test: serum test
serum test of sCD58 and TGFbeta1
Low malignant grade of pancreatic neoplasms
IPMN, MCN, PNEN, and SPN
Diagnostic test: serum test
serum test of sCD58 and TGFbeta1
Pancreatitis
acute, chronic, and auto-immune pancreatitis
Diagnostic test: serum test
serum test of sCD58 and TGFbeta1
Auto-immune diseases
SLE, RA, et al
Diagnostic test: serum test
serum test of sCD58 and TGFbeta1
Pancreatic-biliary infections
cholecystitis, cholangitis, et al
Diagnostic test: serum test
serum test of sCD58 and TGFbeta1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Qiaofei Liu, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JS-2954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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