EK 366/2003Recruiting

Establishment of a blood sample bank in the field of gynecologic oncology for research on tumor markers and circulating tumor cells

Gender
Women and men
Age
18 years and older
Trial type
Observational
Line of therapy
all
Phase
—

What is this trial about?

The systematic collection and analysis of biological samples is of central importance for the further development of cancer diagnostics and therapy. The goal of the EK 366/2003 study is to establish a blood sample bank to provide biological materials, together with clinical data, for current and future cancer research. The focus is particularly on the analysis of tumor markers and tumor cells. Patients aged 18 to 90 with a malignant tumor, a benign condition such as a benign tumor or an inflammatory disease, as well as healthy individuals serving as a control group, are eligible to participate in this study. This is an observational study in which no new drugs or therapies are being tested.

Trial flow

Requirements

Diagnosis: Malignant or inflammatory disease or healthy control

Age: 18–90 years

Line of therapy: Unabhängig von Therapielinie

Key inclusion criteria: only one disease

Allocation

Stratifizierung anhand von Markern

Treatment

Patients with malignant tumorBlood sample is collected during routine blood collection by a medical doctor
Patients with benign diseaseBlood sample is collected during routine blood collection by a medical doctor
Healthy controlBlood sample is collected during routine blood collection by a medical doctor

Follow-up

Detailed description

Advances in cancer diagnosis and treatment are increasingly based on what is known as translational research. This approach involves translating scientific findings into clinical practice as quickly as possible. A key prerequisite for this is the systematic collection of biological samples in combination with clinical data.

The goal of this observational study is to establish a comprehensive blood sample bank that includes samples from patients with various cancers and benign conditions, as well as from healthy control subjects. The diseases under investigation include, among others, ovarian cancer, breast cancer, colorectal cancer, lung cancer, and tumors of the female reproductive organs and endocrine glands. The blood samples are stored in a database along with clinical data and made available for future research projects. The goal is to gain new insights into the development and progression of cancer. Among other things, the study examines tumor markers that may provide clues about the course of the disease or the response to treatment. In addition, genetic analyses are conducted, for example, to identify changes in the genome (e.g., mutations or other genetic alterations). Another focus is the detection and characterization of circulating tumor cells in the blood, which are considered the cause of cancer spread and metastasis (metastasis). As part of the study, an additional blood sample will be collected during a routine blood draw. No further treatment will be administered.

Eligible participants include patients aged 18 to 90 with malignant tumors (ovarian and breast cancer, colorectal cancer, lung cancer, tumors of the female reproductive organs, and endocrine glands), benign conditions, as well as healthy control subjects.Participants must not have multiple concurrent malignant and inflammatory conditions. In addition, patients must be in sufficiently good general health to participate in the study.

Facts

  1. What conditions: various types of cancer (ovarian cancer, breast cancer, colorectal cancer, lung cancer, tumors of the female reproductive organs, tumors of the endocrine glands), as well as benign conditions and healthy control subjects
  2. Cancer characteristics: the presence of only one malignant or inflammatory disease
  3. What the study investigates: Establishment of a blood sample bank for research into tumor markers, genetic alterations, and circulating tumor cells
  4. Study objective: To provide biological samples and clinical data for current and future cancer research
  5. Study duration: 14 years (estimated completion in December 2026)
  6. Study characteristics: Observational study, case-control design, three groups (malignant tumors, benign controls, healthy controls)

Trial sites

3 trial sites in Germany are listed.

  • Charité – Universitätsmedizin Berlin

    Augustenburger Platz 1, 13353 Berlin

    Recruiting

  • Universitätsklinikum Freiburg

    79106 Freiburg

    Closed

  • University Clinic of Ruhr University Bochum

    44626 Herne

    Closed

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT01763125) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.