Molecularly Aided Stratification for Tumor Eradication Research

Rare Cancers Clinical Trial

— NCT-MASTER  

Official title:

NCT MASTER Plattform Molecularly Aided Stratification for Tumor Eradication Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05852522
• Other study ID #: TMO0001
• Status: Recruiting
• Start date: November 11, 2018
• Est. completion date: October 2029

Study information

• Verified date: May 2023
• Source: German Cancer Research Center
• Contact: Richard F Schlenk, M.D.
• Phone: +49 6221
• Email: richard.schlenk[@]nct-heidelberg.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

NCT/DKFZ/DKTK MASTER is a prospective, continuously recruiting, multicenter observational study for biology-guided stratification of adults with rare cancers, including rare subtypes of common entities, using comprehensive molecular profiling, and clinical decision-making in a multidisciplinary molecular tumor board.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: October 2029
• Est. primary completion date: October 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Rare cancer (Incidence <6/100,000 persons/year) or Rare subtype of a more common entity (case-by-case decision; example: pancreatic ductal adenocarcinoma without KRAS mutation)

Metastatic and/or locally advanced cancer with no curative therapy option and indication for systemic therapy

Exclusion Criteria:

Severe neurological or psychiatric disorder interfering with the ability to give oral and written informed consent

Related Conditions & MeSH terms

• Rare Cancers

Locations

Country	Name	City	State
Germany	German Cancer Research Center	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
German Cancer Research Center	German Consortium for Translational Cancer Research

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Horak P, Heining C, Kreutzfeldt S, Hutter B, Mock A, Hullein J, Frohlich M, Uhrig S, Jahn A, Rump A, Gieldon L, Mohrmann L, Hanf D, Teleanu V, Heilig CE, Lipka DB, Allgauer M, Ruhnke L, Lassmann A, Endris V, Neumann O, Penzel R, Beck K, Richter D, Winter U, Wolf S, Pfutze K, Georg C, Meissburger B, Buchhalter I, Augustin M, Aulitzky WE, Hohenberger P, Kroiss M, Schirmacher P, Schlenk RF, Keilholz U, Klauschen F, Folprecht G, Bauer S, Siveke JT, Brandts CH, Kindler T, Boerries M, Illert AL, von Bubnoff N, Jost PJ, Spiekermann K, Bitzer M, Schulze-Osthoff K, von Kalle C, Klink B, Brors B, Stenzinger A, Schrock E, Hubschmann D, Weichert W, Glimm H, Frohling S. 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. Epub 2021 Jun 10. — View Citation

Horak P, Klink B, Heining C, Groschel S, Hutter B, Frohlich M, Uhrig S, Hubschmann D, Schlesner M, Eils R, Richter D, Pfutze K, Georg C, Meissburger B, Wolf S, Schulz A, Penzel R, Herpel E, Kirchner M, Lier A, Endris V, Singer S, Schirmacher P, Weichert W, Stenzinger A, Schlenk RF, Schrock E, Brors B, von Kalle C, Glimm H, Frohling S. Precision oncology based on omics data: The NCT Heidelberg experience. Int J Cancer. 2017 Sep 1;141(5):877-886. doi: 10.1002/ijc.30828. Epub 2017 Jun 21. — View Citation

Jahn A, Rump A, Widmann TJ, Heining C, Horak P, Hutter B, Paramasivam N, Uhrig S, Gieldon L, Drukewitz S, Kubler A, Bermudez M, Hackmann K, Porrmann J, Wagner J, Arlt M, Franke M, Fischer J, Kowalzyk Z, William D, Weth V, Oster S, Frohlich M, Hullein J, Valle Gonzalez C, Kreutzfeldt S, Mock A, Heilig CE, Lipka DB, Mohrmann L, Hanf D, Oles M, Teleanu V, Allgauer M, Ruhnke L, Kutz O, Knurr A, Lassmann A, Endris V, Neumann O, Penzel R, Beck K, Richter D, Winter U, Wolf S, Pfutze K, Georg C, Meissburger B, Buchhalter I, Augustin M, Aulitzky WE, Hohenberger P, Kroiss M, Schirmacher P, Schlenk RF, Keilholz U, Klauschen F, Folprecht G, Bauer S, Siveke JT, Brandts CH, Kindler T, Boerries M, Illert AL, von Bubnoff N, Jost PJ, Metzeler KH, Bitzer M, Schulze-Osthoff K, von Kalle C, Brors B, Stenzinger A, Weichert W, Hubschmann D, Frohling S, Glimm H, Schrock E, Klink B. 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/j.annonc.2022.07.008. Epub 2022 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	Time period of progression survival from date of multiomics analysis	5 years
Primary	overall survival	time period of survival from date of diagnosis	10 years
Secondary	response to antitumor treatment	response according to RECIST v.1.1 criteria to antitumor treatment applied after multiomics analysis	5 months