Using of Costimulatory and co Inhibatory Immune Checkpoints as Diagnostic and Prognostic in Breast Cancer

December 14, 2023 updated by: Asmaa Mohammed Soliman Khalfallah, Assiut University

Role of Soluble Immune Checkpoints Molecules as Diagnostic and Prognostic Markers in Breast Cancer Patients

Checkpoint proteins regulate the immune system; breast cancer cells exploit the up-regulation or down-regulation of these proteins to evade anti-tumour immune responses . It is now well recognized that advanced metastatic BC and early disease are associated with both localized and systemic immune dysfunction .in this study levels of soluble immune checkpoint molecules sTIM3 and sCD40 will be measured and compared with tissue form ,then follow up to patients' prognosis and the relation to markers levels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

Detailed Description

Breast cancer is the most common malignant tumour and the leading cause of cancer-associated mortality among women .Although comprehensive therapies exist, patient response to the treatments significantly varies, which partly attributed to varying antitumor immune responses .Immunotherapy is being recognized as a key therapeutic modality for cancer and represents one of the most promising therapies. Checkpoint proteins regulate the immune system. Breast cancer (BC) cells exploit the up-regulation or down-regulation of these proteins to evade anti-tumour immune responses. Notwithstanding the existence of profound immune dysregulation in advanced metastatic breast cancer (BC), it is now well recognized that early disease is also associated with both localized and systemic immune dysfunction . Recently, soluble co-inhibitory immune checkpoint molecules (ICMs) have been implicated as being potential mediators of the systemic immune dysregulation . Prominent among these soluble co inhibitory ICMs are: cytotoxic T-lymphocyte-associated protein (CTLA-4), programmed cell death protein 1 (PD-1) and its ligand, PD-L1, lymphocyte activation gene 3 (LAG-3) and T- Cell immunoglobulin and mucin-domain-containing protein 3 (TIM-3) . A study showed that resistance to anti-CTLA-4 or anti PD-1/PD-L1 inhibitors is compensated by up regulation of other immune checkpoints, such as Tim-3 . Consequently, Tim-3 has gained prominence as a potential candidate for cancer immunotherapy. Blocking Tim-3 with other checkpoint inhibitors has been shown to enhance antitumor immunity and suppress tumour growth in several preclinical tumour models. Increasing numbers of novel receptors and ligands have recently been found in the immune system. Some take part in a costimulatory interactions, such as Glucocorticoid-induced TNFR-related protein (GITR), GITR Ligand, CD27, CD28, CD40, CD80, CD86 and Inducible Co-Stimulator (ICOS) . CD40-CD40 ligand (CD40L) pathway is a member of the TNF superfamily and is expressed at various levels on antigen-presenting cells, epithelial cells, and hematopoietic progenitor cells . The CD40-CD40L costimulatory pathway has been shown to play a crucial role in humoral responses in humans, these cytokines modulate the function of T lymphocytes in antitumor responses. Few Review studies have reported the levels of sTIM-3 and CD40 in the literature, we are going to assess them and compare different stages of breast cancer .Previous study reported that, the level of Plasma concentration of the co-stimulatory immune checkpoint CD40 as well as the co-inhibitory molecule TIM-3 were all significantly lower in early breast cancer patients compared to healthy controls. Following neoadjuvant chemotherapy NAC, the plasma concentrations of the soluble co-stimulatory ICM sCD40 and soluble co inhibitory ICM sTIM-3 were significantly increased

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 (Estimated)

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.
84

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.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Female patients with breast cancer and healthy females as controls

Description

Inclusion Criteria:

  • Female patients with breast cancer aged > 18 years attending the Medical Oncology department of South Egypt Cancer Institute

Exclusion Criteria:

  • Patients on chemotherapy
  • A history of any other malignancy
  • known (HIV) and/or hepatitis B or hepatitis C viruses,
  • pregnancy or breast feeding
  • patients or controls that refuse to be a part of the study.

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

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
Time Frame
evaluate the levels of sTIM-3 and sCD40 in breast cancer patients in different stages and follow up their role in disease prognosis compared with healthy controls. Results will be compared with the previous studies.
Time Frame: study will take about 12months to be completed
study will take about 12months to be completed

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.
Assiut University

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 Director: Lamiaa Fadel, lecturer, Assiut University

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 (Estimated)

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, 2024

Primary Completion (Estimated)

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.
October 1, 2025

Study Completion (Estimated)

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).
December 5, 2023

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.
December 5, 2023

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.
December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
December 20, 2023

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.
December 14, 2023

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.
December 1, 2023

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.
  • Immune checkpoints in cancer

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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