Registry of the molekularen tumor boards of the University Cancer Centers Schleswig-Holstein (short title: „UCCSH-MTB-registry“)
Organizational Data
- DRKS-ID:
- DRKS00028806
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-05-09
- Last update in DRKS:
- 2022-05-09
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The molecular tumor board is a highly specialized service at the interface of the latest scientific knowledge with clinical medicine. The molecular tumor board aims to make innovative diagnostic methods and new therapeutic approaches accessible to individual patients. This process itself is part of a scientific evaluation. Within the registry of the molecular tumor board, data on the previous course of treatment, the diagnostics carried out in the molecular tumor board and any subsequent therapy recommendations will be summarized. In addition, information on whether the therapy recommendation has been followed and how well the patient responded to it will be collected. The registry is intended to test the benefit of the molecular tumor board itself. At the same time, the growing data set can be used to learn from it when discussing new patients in comparable treatment situations.
Brief summary in scientific language
Contemporary high-throughput sequencing (whole exome / gene panel / transcriptome sequencing in combination with conventional diagnostic methods (immunohistochemistry / FISH) yields high-resolution molecular profiles of individual tumors and often reveals their driver mechanisms. Molecular tumor boards, including the one of the University Medical Center Schleswig-Holstein established across both campuses, are focused on advising and carrying out rational and comprehensive molecular tumor characterization for patients with advanced or rare disease when guideline-based therapies are exhausted. Based on intensive literature and database research, individual therapy recommendations are made, and can be implemented in individual healing attempts. The scientific evaluation is critical to identify a potential benefit of and to further improve this highly specialized service of personalized medicine. For this purpose, clinical data of patients presenting at the molecular tumor board will be documented together with any subsequent treatment information. A basic clinical data set has been defined including the conventional diagnostics and therapies carried out previous to discussion in the molecular tumor board. Furthermore, findings of the molecular characterization are recorded together with ensuing therapy recommendations. In addition, follow up information will be documented, in particular the implementation of the recommended treatment, therapy response, and any further therapy. Within the register data collected in the context of patient care on clinical course and tumor profile, will be recorded in a standardized and systematic manner. The primary goal is to determine the potential benefit of referring patients to the molecular tumor board. The UCCSH-MTB registry enables a first comprehensive assessment of the benefit of the molecular tumor board in the UCCSH and serves for its continuous improvement.
Health condition or problem studied
- ICD10:
- C00-C97 - Malignant neoplasms
- Free text:
- solid tumors and hematologic neoplasia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- In this registry, clinical data of patients presenting at the molecular tumor board will be documented together with any subsequent treatment information. A basic clinical data set has been defined including the conventional diagnostics and therapies carried out previous to discussion in the molecular tumor board. Furthermore, findings of the molecular characterization are recorded together with ensuing therapy recommendations. In addition, follow up information will be documented, in particular the implementation of the recommended treatment, therapy response, and any further therapy. Within the register data collected in the context of patient care on clinical course and tumor profile, will be recorded in a standardized and systematic manner. The primary goal is to determine the potential benefit of referring patients to the molecular tumor board. The UCCSH-MTB registry enables a first comprehensive assessment of the benefit of the molecular tumor board in the UCCSH and serves for its continuous improvement.
Endpoints
- Primary outcome:
- Determination of the potential benefit of presenting to the Molecular Tumor Board when no therapy option according to clinical guidelines remains/ exists.
- Secondary outcome:
- - Determination of the rate of therapy-relevant molecular markers associated with the molecular diagnostic method used. - Documentation of previously undescribed aberrations within and across tumor entities. - Documentation of the frequency of previously known driver mutations in rare tumor entities. - Gaining knowledge through documentation of therapy response and outcome of individual healing attempts as a basis for therapy recommendations in future cases with similar initial situation.
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center UCCSH Schleswig-Holstein
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2022-01-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 1000
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 199 Years
- Additional Inclusion Criteria:
- Referral to the molecular tumor board
Exclusion Criteria
informed consent not signed
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Schleswig-Holstein, Lübeck Klinik für Hämatologie und OnkologieProf. Nikolas von BubnoffRatzeburger Allee 16023538 LubeckGermany
- Telephone:
- 045150044151
- Fax:
- 045150044154
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uksh.de/haemonk-luebeck/Unsere+Klinik/Kontakt.html
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Schleswig-Holstein Universitäres Cancer Center Schleswig-HolsteinDr. Stephanie FliednerRatzeburger Allee 16023538 LubeckGermany
- Telephone:
- 045150018511
- Fax:
- 045150018514
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uksh.de/uccsh
Contact for Public Queries
- Address:
- Universitätsklinikum Schleswig-Holstein Universitäres Cancer Center Schleswig-HolsteinDr. Stephanie FliednerRatzeburger Allee 16023538 LubeckGermany
- Telephone:
- 045150018511
- Fax:
- 045150018514
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uksh.de/uccsh
Principal Investigator
- Address:
- Universitätsklinikum Schleswig-Holstein Universitäres Cancer Center Schleswig-HolsteinDr. Stephanie FliednerRatzeburger Allee 16023538 LubeckGermany
- Telephone:
- 045150018511
- Fax:
- 045150018514
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uksh.de/uccsh
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Schleswig-Holstein, Lübeck Klinik für Hämatologie und OnkologieRatzeburger Allee 16023538 LubeckGermany
- Telephone:
- 045150044151
- Fax:
- 045150044154
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uksh.de/haemonk-luebeck/Unsere+Klinik/Kontakt.html
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Med. Fakultät der Universität zu LübeckRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- +49-451-5004639
- Fax:
- +49-451-5003026
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-11-18
- Ethics committee number:
- 21-470
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-11-26
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- According to the declaration of consent, the data can be passed on anonymously.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry