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MASTER Programme


Overview

  • Patients with rare types of tumours, or rare subtypes of common types of cancer, can participate in the MASTER programme.
  • Their cancer must be at an advanced stage, requiring treatment with drugs that act throughout the body. Another prerequisite is that there is no standard therapy available for their situation.
  • In MASTER, the participants' cancer cells are examined comprehensively. The aim is to use the results to provide new treatment recommendations. Any possible therapy takes place outside the study.

Study status: The programme is continuously accepting patients (recruitment open).

Cancer develops due to changes in the genetic material of cells. Cancer cells therefore have different properties when compared to healthy cells in the body. These properties can be targets for targeted cancer drugs, for immunotherapy, for chemotherapy, or for combinations thereof. 

Genetic changes vary from person to person, even within the same type of cancer. This is why a drug may work for one person but not for another.

That is why researchers in the MASTER programme are investigating the properties of tumour cells provided by the programme participants using various modern methods. The aim is to find matching active substances that target changes in the tumour of the respective patient.

Important to know

Patients participating in the MASTER programme undergo particularly thorough molecular testing. The therapy itself is not part of the MASTER programme, but may be part of a follow-up study. If this is not possible, the costs of treatment may need to be clarified individually with the health insurance company.

Patients with different tumours or types of cancer can participate in the MASTER programme. However, they must meet certain requirements. The most important ones are:

  • It is a rare type of cancer or a rare subtype of a common type of cancer.
  • The disease must already be advanced.
  • The decision to undergo drug treatment must be pending for the patient.
  • There are no standard treatments remaining that are likely to be effective for the individual patient.

The study is being conducted for rare cancers because there are often few or sometimes no clinically proven therapies available for patients with these types of cancer. 

Good to know

Experts refer to a cancer as rare if fewer than 6 out of 100,000 people develop it each year. Overall, around 25 out of 100 adult cancer patients in Germany have a rare form of cancer.

For information on the other requirements that patients must meet in order to participate in the study, please refer to the section Who is the study suitable for?.

MASTER is the abbreviation for the English study title "Molecularly Aided Stratification for Tumor Eradication Research". This means that researchers are investigating the molecular properties of tumour cells. This enables them to find out which active substances could be effective in combating the tumour. 

Modern methods of molecular diagnostics are used, which researchers primarily employ to examine the genetic material of the participants.

Objectives of the MASTER programme

The scientists involved in the study aim to

  • find treatment approaches for individual patients specifically tailored to the tumour‘s biomarkers.
  • identify which patients can be included in clinical trials with such biomarkers.
  • discover new targets for cancer therapies and find out which patients could benefit from certain therapies. This should help to develop future clinical trials.
  • better understand cancer as a whole. In other words, why cancer spreads, progresses or becomes insensitive to therapies. This knowledge can also help other researchers in their work.

Promising results

To date, the results show that researchers are able to give individual treatment recommendations to 8 out of 10 participants. Some of these patients can be treated in a further clinical trial.

In just under 5 out of 100 participants, there are indications that the original diagnosis should be reviewed.

In about 1 in 10 participants, the researchers find a hereditary cancer-causing mutation. Affected patients and their family members can request genetic counselling if they wish. 

Patients can participate in the study if ALL of the following conditions are met:

  • They have a rare type of cancer, or the cancer belongs to a rare subgroup of a common cancer.
  • The participant is 18 years of age or older.
  • The cancer has formed a metastasis and/or is locally advanced, and there is no scientifically proven therapy that can be expected to be effective. From a medical point of view, the patient can and should receive whole-body (systemic) therapy.
  • The person concerned does not have any significant health restrictions: experts classify their performance status according to the Eastern Cooperative Oncology Group (ECOG) as less than or equal to 2.
  • There are no serious comorbidities involving other organs.
  • A fresh tissue sample can be collected for examination.

The patient must sign a written consent form.


Patients cannot participate in the study if at least one of the following points applies:

  • The patient does not meet the above requirements for the study.
  • The patient also has a serious physical or mental illness that prevents participation.
  • The patient's current alcohol or drug consumption precludes participation in the study.
  • For women: The patient is pregnant or breastfeeding.

The MASTER study is a/an:

  • multicentre study: Patients can participate in various study centres in Germany.
  • observational study: Researchers observe the participants and investigate correlations, but they do not intervene in the course of the disease with therapy as part of the study.
  • single-arm study: This means that there is no control group. All patients receive the same diagnostics and thus participate in the same study group.

Further reading

You can read about the different types of studies, how they differ and their advantages and disadvantages in our overview text on clinical studies. 

Procedure for patients

Graphical representation of the various steps that cancer patients go through in the MASTER study. Explanation in the text.
Procedure of the MASTER programme for patients

(1) Once the patient has registered and been deemed suitable for MASTER, an informational meeting takes place during consultation hours at the respective clinic of the National Centre for Tumour Diseases (NCT).

 

Further reading

You can find out how to register for MASTER in the section of the same name.

During the consultation the study doctor will explain the study in detail to participants. If potential candidates wish to participate, they must submit a written declaration of consent. They can also indicate whether they would like to be informed about any additional genetic disease risks that may be found and that could be inherited.

 

(2) For their research, scientists require tumour cells and, for comparitive purposes, healthy cells from the same person. This material is obtained in various ways, for example through a biopsy or a blood sample. 

Sometimes a fresh tissue sample is already available or can be obtained during an upcoming operation, for example.

It takes about 4–6 weeks from the time suitable sample material is available to a possible treatment recommendation.

(3) In laboratories at DKFZ and at the NCT Heidelberg, researchers carry out various tests on the participants' samples. These include:

  • A standard genetic analysis of the entire genome (Whole Genome Sequencing, WGS).
  • Alternatively, for some participants, a complete analysis of the areas of the genome that only store genetic information for the proteins in the body (Whole Exome Sequencing, WES).
  • An examination of the activity of genes or areas of the genome (RNA sequencing).
  • In addition, the researchers analyse regulatory processes that influence gene activity (DNA methylation).
  • Further tests may also be carried out. For example, Some of the participants will be given tests can be carried out to find out how well certain drugs work for some participants. Or to determinethem or how high their risk of experiencing unwanted side effects is.
  • The various stages of the process are quality-assured.

(4) The researchers interpret the data obtained using bioinformatics methods. This provides them with information about the individual changes in the tumour of the study participant concerned.

Based on the results, scientists and doctors can identify possible targets in the tumour cells as well as corresponding active substances. Furthermore, they can make an assessment of the chances of success regarding a potential therapy.

(5) A team of experts from various disciplines gather regularly to take part in a molecular tumour board. Participants include scientists, oncologists and pathologists from various locations. Based on the biomarkers found they jointly assess whether one or more therapy recommendations are appropriate for the individual disease situation. The recommendations may include targeted therapy, immunotherapy or chemotherapy, either individually or in combination. 

(6) The experts share their findings and recommendations with the attending oncologist. Together, with the study participant, they decide on further treatment.

Important to know

The therapy is not part of the MASTER programme. If the recommended therapy involves a drug that is not approved for the type of cancer in question (off-label use), an application must be submitted to the health insurance company in advance to cover the costs. Based on the results, some patients may be able to receive treatment through a different clinical trial.

All participants will continue to be monitored after the examinations. To this end, the attending physicians will forward data on the further course of the disease to the study team in Heidelberg. This will enable the researchers to determine whether and how well the proposed treatment is working.

These are the potential advantages of participating in the MASTER study:

  • Patients with rare types of cancer have access to modern precision oncology. This can improve the treatment of patients with rare tumour diseases.
  • The individual disease situation is discussed and analysed by experts across different locations.
  • The results of genetic analysis and other tests may contribute to new treatment approaches for the patient's cancer.
  • Many of the participants receive at least one treatment recommendation that is tailored (personalised) to their cancer.
  • The proposed therapy could be more effective than previous therapies or the therapies that would have been offered to participants without these analyses. They could also experience fewer side effects.
  • Based on the analyses, some of those affected are given the opportunity to be treated in a clinical trial.
  • In some participants hereditary mutations are found that increase the risk of further cancers. They and their relatives can take advantage of genetic counselling and possibly take preventive measures.

 

However, participation in the MASTER study may also involve risks:

  • Sample collection carries minor risks, such as post-procedural bleeding and/or inflammation.
  • One possible outcome of the tests is that the researchers are unable to recommend treatment based on the collected data. Moreover, the biological materials could be of insufficient quality for sufficient data collection.
  • A hereditary predisposition to cancer may be found. Participants will then learn (if they have consented to the disclosure of this information) about future cancer risks, possibly also for family members.
  • Despite comprehensive data protection and high data security, there is a small residual risk that genetic data could be traced back to the individual if this data falls into the wrong hands. 

Further reading

You can read about the general advantages of participating in a therapeutic or diagnostic study and whether there may also be disadvantages in the overview text on clinical studies.

Where is the study being conducted?

Cancer patients can participate in the MASTER programme through the participating Comprehensive Cancer Centres or clinics of the NCT or the German Consortium for Translational Oncology (DKTK). The treating oncologist is responsible for registration. In addition, the MASTER programme works with private oncologists and oncology centres, including the German Cancer Aid-funded Centres of Excellence in Oncology.

What costs will participants incur?

Participation in the study is free of charge for patients. However, they will not receive any expense allowance. Travel costs will not be reimbursed as part of the study.

If you have any questions about the financing of the study, please ask the study team, for example, during the informed consent process.

Treatment based on the recommendations is not part of the MASTER programme Depending on the situation, patients may be treated in another clinical study. In this case, the costs will be covered by the respective study sponsor. Otherwise, an application for coverage of the costs of therapy must be submitted to the health insurance company in advance.

How many participants will the study accept? Where are there still places available?

The study is ongoing. Patients can participate at all of the study centres listed.

In principle, any oncologist can register patients for MASTER. Cancer patients who are interested should first discuss with their treating physician whether the study is suitable for them. If necessary, the physician will contact the nearest NCT. Interested parties can obtain the documents and information required for registration from the study secretariat in Heidelberg at master-at-nct-heidelberg.de. The referring doctor at the NCT fills out the registration form and submits the documents.

Are you interested in participating? If so, the study office at the respective NCT clinic will contact you and arrange an appointment during consultation hours.

Further reading

You can read about what happens after registration in the section How is the study conducted?.

Those interested can find out more about the MASTER programme on the website of the National Centre for Tumour Diseases (NCT) Heidelberg. 

There you will also find a flyer (PDF) and explanatory videos with detailed information (in German).

The study is being supported by patient experts from the German Sarcoma Foundation (Deutsche Sarkom-Stiftung e.V.) and Zielgenau – Patient Network for Personalised Lung Cancer Therapy (Zielgenau – Patienten-Netzwerk Personalisierte Lungenkrebstherapie e.V.).
 

Coordinating study director:

Prof. Dr. Stefan Fröhling
NCT Heidelberg
Im Neuenheimer Feld 460
69120 Heidelberg
Email: master-at-nct-heidelberg.de

Scientific publications (selection)

Horak P, Heining C, Kreutzfeldt S et al. Comprehensive Genomic and Transcriptomic Analysis for Guiding Therapeutic Decisions in Patients with Rare Cancers. Cancer Discov. 2021 Nov;11(11):2780-2795. doi: 10.1158/2159-8290.CD-21-0126. 

Jahn A, Rump A, Widmann TJ et al. Comprehensive cancer predisposition testing within the prospective MASTER trial identifies hereditary cancer patients and supports treatment decisions for rare cancers. Ann Oncol. 2022 Nov;33(11):1186-1199. doi: 10.1016/

Mock A, Teleanu MV, Kreutzfeldt S, et al. NCT/DKFZ MASTER handbook of interpreting whole-genome, transcriptome, and methylome data for precision oncology. NPJ Precis Oncol 7:109, 2023. doi: 10.1038/s41698-023-00458-w


This study description was prepared by authors from the Cancer Information Service, under the direction of Dr. S. Weg-Remers, based on the study documentation.