Isolation and immune profiling of human B lymphocytes for the development of potential diagnostic and therapeutic antibodies

Completed

Conditions: endometrial cancer
Uterine cancer
10038594

Registration Number: NL-OMON55081

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 67

Inclusion Criteria

• Female participants who are at least 18 years of age on the day of signing
informed consent with histologically confirmed primary diagnosis of uterine
cancer who are intended to be treated with hysterectomy will be enrolled in
this study.
• The participant (or legally acceptable representative if applicable) provides
written informed consent for the trial.

Exclusion Criteria

• History of an autoimmune disease, specifically hepatitis A virus (HAV),
hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency
virus (HIV), or any other systemic intercurrent disease or condition that might
affect the immunocompetence of the patient, or treatment with systemic highly
immunosuppressive therapy (e.g. transplant recipients or patients who underwent
a splenectomy)
• Use of systemic continuous corticosteroid therapy (e.g. prednisone i.v. or
p.o. >7.5 mg / day).
• History of a second malignancy except for curatively treated low-stage tumors
with a histology that can be differentiated from UC.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to characterize B cell immune responses in uterine<br /><br>cancer patients.<br /><br><br /><br>This pilot study is considered successful when;<br /><br>• in 20% of the patients tumor binding antibodies are found (using B cells<br /><br>derived from peripheral blood)<br /><br>• in 20% of the patients tumor binding antibodies are found (using B cells<br /><br>derived from tertiary lymphoid structures, if present)<br /><br>Isolated B cells (intratumoral or peripheral blood) will be analyzed using e.g.<br /><br>flow cytometry, immunochemistry, DNA/RNA sequencing and antibody production.<br /><br>Tumor binding antibodies are defined as binding of the antibody to at least 2<br /><br>endometrial carcinoma cell lines, which will be used as surrogate tumor model. </p><br>

Secondary Outcome Measures