CLINICAL STUDIES
Ovarian cancer (ovarian carcinoma) and endometrial cancer (endometrial cancer) are among the most common cancers of female reproductive organs. Ovarian cancer is particularly aggressive and the cure rate is less than 30%. There is no early detection method for either ovarian cancer or endometrial carcinoma. If it was possible to detect ovarian cancer and endometrial cancer at an earlier stage of the disease, this would lead to a tremendous improvement in the chances of survival. If it were possible to discover the precursors of these diseases, then their emergence could be completely prevented.
OUTLOOK
Together with the University of Washington and TwinStrand Biosciences we have performed a pilot study proofing that DS can be successfully employed for TP53 sequencing of UtL samples. Together with the “Early Detection Research network - EDRN Breast/GYN Collaborative Group” a study is in planning on the sensitivity and specificity of the UtL concept – UtL plus DS – in detecting early stage HGSC or STIC.
Pilot study of the Lavage of the Uterine cavity for the Diagnosis of Serous Tubal Intraepithelial Carcinoma – LUSTIC Study
https://clinicaltrials.gov/ct2/show/NCT02039388
The aim of this study is the "proof of concept" that, by means of irrigation of the uterine cavity and fallopian tubes, first, cells of occult ovarian carcinomas and, secondly, their precursors can be recovered and detected. In this study, women at high risk for breast and ovarian cancer are being investigated who have decided to have their ovaries and fallopian tubes removed in order to minimize their risk of developing ovarian carcinoma. At the beginning of the operation, the flushing is then carried out. At the time of the operation, about 5% to 10% of all women already have a fallopian tube precancer or an occult carcinoma. In these cases, it is then examined whether cells of this occult carcinoma or precursors are found in the rinsing fluid. The first "proof of concept" has already been achieved and it was found in the case of occult carcinoma in the irrigation fluid, an extremely high tumor cell content of 17 percent. Whether cells in the rinsing liquid can also be found in the case of precursors is still pending
Lavage of the Uterine cavity for the Diagnosis of Ovarian and tubal Carcinoma – Study of sensitivity and specificity - LUDOC II Study
https://clinicaltrials.gov/ct2/show/NCT02518256
The potential of the lavage concept in the differential diagnosis of ovarian or ovarian cysts will be investigated in this study. The pleasing and surprising results of our pilot study, in which 80% of all examined patients with ovarian cancer were able to detect cancer cells in the rinsing fluid, form the basis for the study, which is now also under international support. This should show, if a conspicuousness on the ovary, which does not appear to be sure malignant or benign in the vaginal ultrasound and therefore an operation is indicated, with the help of the analysis of the "lavage concept" a better allocation / assessment is possible. For example, patients may be able to avoid surgery altogether or, in the case of very high suspicion, be assigned to a specialized center. In this study, 540 patients undergoing surgery for suspected ovarian cancer are being examined. The aim is to investigate the sensitivity and specificity of the "lavage concept"
Pilot study of the Lavage of the Uterine cavity for the Diagnosis of Endometrial Carcinoma – LUDEC Study
https://clinicaltrials.gov/ct2/show/NCT02387645
This study will examine women who are curetted because of suspected endometrial cancer. If these women are on the operating table, then a rinse of the uterine cavity is performed before the operation and checks whether in the presence of a carcinoma carcinoma cells are found in the rinsing fluid. It is planned to investigate 40 such cases. In the four cases evaluated so far, cancer cells have been found in all rinsing fluids. Due to lack of resources, this study is currently dormant.