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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55081

Enrollment

Registered

2020-05-25

Start date

2021-10-29

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometrial cancer Uterine cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results