Clinical trials – Gynaecological oncology

Clinical studies are essential to investigate and further develop the effectiveness and safety of new therapies. They also give patients access to innovative diagnostic and treatment methods that are not yet available outside of clinical trials. The study center of the Department of Gynecological Oncology at NCT Heidelberg has many years of experience in the planning and implementation of clinical studies for breast cancer and gynecological malignancies.

Diagnostics-Trials for breast cancer: CATCH & COGNITION

COGNITION and CATCH use information from the molecular analysis of genetic material in breast cancer to develop tailored treatment options for patients.

Clinical trial COGNITION

The clinical trial COGNITION is aimed at patients with early breast cancer (non-metastatic) who are being treated with neoadjuvant therapy. Ideally, patients are included into the trial before neoadjuvant chemotherapy but is still possible in case of low response to chemotherapy before operation.

The aim of the clinical trial is to offer patients who have a low response to neoadjuvant therapy and who accordingly have an increased risk of relapse, in addition to the standard procedure with individualized therapy, a safety anchor to reduce the risk of relapse.

Treating physicians at NCT Heidelberg/ a participating trial center will screen for enrolment criteria (inclusion into the trial) and clarify all details of the trial and planned diagnostics. The following information is intended to help you answer the first questions.


Why is the genetic material of a tumour analysed?
Cancer is caused by abnormal changes in the genome. The pattern of these changes can vary widely between people and between different tumors. The identification of individually modified genetic patterns helps to better understand each individual disease and possibly treat it in a targeted manner. Prospectively, the targeted use and combination of suitable drugs that are adapted to molecular target structures should further improve the treatment of cancer and prevent patients from experiencing unnecessary side effects of ineffective medication.

What is targeted therapy?
Currently, increasing amounts of medications, that specifically target altered molecules in malignant cells, appear on the market. These medications influence genetically modified cancer cells preferably and mostly spare healthy cells of the body. So-called small molecules or antibodies are examples for such medications, which inhibit growth of malignant cells through targeted attack within a tailor-made molecular therapy.

»Targeted therapy: How does it work? (ePaper of the Cancer Information Service, only available in German)

What does the abbreviation COGNITION stand for?
COGNITION stands for “Comprehensive assessment of clinical features, genomics and further molecular markers to identify patients with early cancer for enrolment on marker driven trials“.

What do we need?
Before start of neadjuvant therapy or in case you have an indication for neoadjuvant therapy or your physician diagnoses a low tumor response to neoadjuvant therapy, we need a current physician's letter and the results of current medical examinations. By examining the latter, we will then consider whether your participation is appropriate to the current status of the disease.
During an appointment as part of the consultation of the gynecological-oncological outpatient clinic at the NCT Heidelberg, you will be informed in detail about the clinical trial and the planned diagnosis. In order to be able to carry out the molecular tests, we need your written consent. We also need fresh tumor tissue and a blood sample for comparison. In the event of poor response to neoadjuvant therapy, it is important to introduce yourself to NCT Heidelberg before the sugery, since it is necessary to collect fresh tumor material for molecular diagnosis.

What will be done with the samples of the COGNITION trial?
First, the tumor tissue sample is examined pathologically to determine the tumor cell content. This is an important indicator for deciding whether the extended molecular diagnostics (tumor genome sequencing) can also be conducted and evaluated. We then extract DNA, the carrier of hereditary information, and RNA, the construction plan of molecules in a cell from the tumor material. The genetic codes of tumor and healthy tissue are determined and compared by sequencing.



 


Which results are delivered by the analysis?
By comparing the sequences of tumorous and healthy tissue, information about changes in the tumor can be obtained. Only a small proportion of the differences identified are known target structures for validated medication. For a large part of the differences, bioinformatic analyses, expert knowledge and additional tests in the laboratory have to be combined in order to evaluate potential routes of targeted therapies. Medical and scientific experts in an interdisciplinary molecular tumor panel discuss specific therapy options and underlying data.





How do I get to know about results?
Your treating physician at the NCT Heidelberg will provide you with advice from the Molecular Tumor Board for a potential further targeted therapy within an affiliated advanced clinical trial (COGNITION-GUIDE).

Do I definitely get therapy advice?
If the material meets all the high quality standards and contains sufficient tumor material and can be sequenced, we will create a profile of tumor-specific changes. In case the tumor profile does not match with available targeted therapies, we cannot suggest new therapy options. If there are important points in the tumor profile for personalized therapy, the attending oncologist at NCT Heidelberg will inform you. If there are suitable molecular targets in the tumor profile, it is possible to prospectively be included in a clinical trial.

Who coordinates COGNITION?

The diagnostics trials are carried out in close cooperation with the German Cancer Research Center (DKFZ) and the Molecular Diagnostics Program at NCT Heidelberg.

Conditions of participation
Participation can be considered if you are diagnosed with early-stage breast cancer and if it is planned that you with neoadjuvant therapy.
Moreover, in case a low response to neoadjuvant therapy was detected, a personal consultation for a potential participation in the clinical trial would be required prior to surgery to enable the tissue collection required for molecular analysis.

How do I register?
Please send a current physician’s letter, all pathological findings and pictures to the contact details below. We collect your data and inform you whether an inclusion would generally be possible. In this case we will make an appointment with you during the consultation of the Division of Gynecological Oncology at the NCT Heidelberg.

Appointment
Tel.: 06221 56-7985
Fax: 06221 56-5320
Frauenklinik.Ambulanz.Onkologie@med.uni-heidelberg.de
Patientenzentrum2.NCT@med.uni-heidelberg.de

Address
Patientenzentrum 2
Im Neuenheimer Feld 460
69120 Heidelberg

Clinical trial CATCH

The clinical trial CATCH is aimed at patients with advanced breast cancer (metastasis). The aim of the trial is to offer further individual targeted therapy options that are tailored to individual genetic tumor biology in addition to standard procedures. Patients must be treated at the NCT Heidelberg from the date of enrolment into the study.

Treating physicians at NCT Heidelberg will screen for enrolment criteria (inclusion into the trial) and clarify all details of the trial and planned diagnostics. The following information is intended to help you answer the first questions.


Why is the genetic material of a tumour analysed?
Cancer is caused by abnormal changes in the genome. The pattern of these changes can vary widely between people and between different tumors. The identification of individually modified genetic patterns helps to better understand each individual disease and possibly treat it in a targeted manner.
Prospectively, the targeted use and combination of suitable drugs that are adapted to molecular target structures should further improve the treatment of cancer and prevent patients from experiencing unnecessary side effects of ineffective medication.

What is targeted therapy?
Currently, increasing amounts of medications, that specifically target altered molecules in malignant cells, appear on the market. These medications influence genetically modified cancer cells preferably and mostly spare healthy cells of the body. So-called small molecules or antibodies are examples for such medications, which inhibit growth of malignant cells through targeted attack within a tailor-made molecular therapy.

»Targeted therapy: How does it work? (ePaper KID, only available in German)

What does the abbreviation CATCH stand for?
CATCH stands for “Comprehensive assessment of clinical features and biomarkers to identify patients with advanced or metastatic breast cancer for marker driven trials in humans“.

What do we need?
A current physician's letter and all results of current medical examinations is required to check eligibility for trial enrolment. By examining the latter, we will then check whether your participation is appropriate to the current status of the disease.
During an appointment as part of the consultation of the gynecological-oncological outpatient clinic at the NCT Heidelberg, you will be informed in detail about the clinical study and the planned diagnosis. In order to be able to carry out the molecular tests, we need your written consent. We also need fresh tumor tissue and a blood sample for comparison. If immediate intervention in the routine standard is planned, please contact us in advance to synchronize processes.

What will be done with the samples of the CATCH trial?
First, the tumor tissue sample is examined pathologically to determine the tumor cell content. This is an important indicator for deciding whether the extended molecular diagnostics (tumor genome sequencing) can also be conducted and evaluated. We then extract DNA, the carrier of hereditary information, and RNA, the construction plan of molecules in a cell from the tumor material. The genetic codes of tumor and healthy tissue are determined and compared by sequencing.

Which results are delivered by the analysis?
By comparing the sequences of tumorous and healthy tissue, information about changes in the tumor can be obtained. Only a small proportion of the differences identified are known target structures for validated medication. For a large part of the differences, bioinformatic analyses, expert knowledge and additional tests in the laboratory have to be combined in order to evaluate potential routes of targeted therapies. Medical and scientific experts in an interdisciplinary molecular tumor panel discuss specific therapy options and underlying data.





How do I get to know about results?
Your treating physician at the NCT Heidelberg / a participating study center will provide you with advice from the Molecular Tumor Board for a potential further targeted therapy within an affiliated advanced clinical trial.

Do I definitely get therapy advice?
If your material is suitable for sequencing, we will create a profile of tumor-specific changes. In this case the tumor profile does not match with any existing therapeutic options, we cannot suggest new therapy options. If there are important points in the tumor profile for personalized therapy, the treating oncologist at NCT Heidelberg / a participating study center will inform you. Possible options are treatment with a drug that is approved for the therapy of other diseases (off-label use), but also appears promising for this special form of breast cancer but also drugs, which are approved for breast cancer (in-label use). In addition, there is the possibility of being included in a clinical trial if the corresponding targets are available.

Who coordinates CATCH?

Prof. Dr. Lichter
Molecular Genetics, DKFZ

 
 
 

The diagnostics trials are carried out in close cooperation with the German Cancer Research Center (DKFZ) and the Molecular Diagnostics Program at NCT Heidelberg.

Conditions of participation
Participation can be considered if you are diagnosed with advanced stage / metastatic breast cancer and it is possible to acquire tissue for molecular diagnostics during the standard routine bioptic or surgical procedures.

How do I register?
Please send a current physician’s letter, all pathological findings and pictures to the contact details below. We collect your data and inform you whether an inclusion would generally be possible. In this case we will make an appointment with you during the consultation of the Division of Gynecological Oncology at the NCT Heidelberg.

Appointment
Tel.: 06221 56-7985
Fax: 06221 56-5320
Frauenklinik.Ambulanz.Onkologie@med.uni-heidelberg.de
Patientenzentrum2.NCT@med.uni-heidelberg.de

Address
Patientenzentrum 2
Im Neuenheimer Feld 460
69120 Heidelberg

Further Clinical Trials

The Division of Gynecological Oncology conducts numerous further diagnostic, observational and clinical trials.

»You can find an overview under "Clinical trials".