Molecularly Aided Stratification for Tumor Eradication Research (NCT-MASTER)

NCT MASTER Plattform Molecularly Aided Stratification for Tumor Eradication Research

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.

Study Overview

• Status: Recruiting
• Conditions: Rare Cancers; Multiomics

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Richard F Schlenk, M.D.; Phone Number: 560 +49 6221; Email: richard.schlenk@nct-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • German Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients from university hospital Heidelberg and all German Consortium for Translation Research sites

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival	Time period of progression survival from date of multiomics analysis	5 years
overall survival	time period of survival from date of diagnosis	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response to antitumor treatment	response according to RECIST v.1.1 criteria to antitumor treatment applied after multiomics analysis	5 months

Collaborators and Investigators

• Sponsor: German Cancer Research Center
• Collaborators: German Consortium for Translational Cancer Research
• Investigators: Principal Investigator: Stefan Fröhling, M.D., German Cancer Research Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2018
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TMO0001

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No