Molecularly Aided Stratification for Tumor Eradication Research

NCT05852522 | Recruiting DMC

• 1 other identifier: TMO0001
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rare Cancers; Multiomics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• response to antitumor treatment

  5 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• German Cancer Research Center: lead
• German Consortium for Translational Cancer Research: collaborator

Study Sites (1)

German Cancer Research Center

Heidelberg, 69120, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 35988656 BACKGROUND

• 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.

  PMID: 34112699 BACKGROUND

• 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.

  PMID: 28597939 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

fresh frozen tumor, DNA, RNA

Study Officials

• Stefan Fröhling, M.D.

  German Cancer Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard F Schlenk, M.D.

CONTACT

+49 6221; richard.schlenk@nct-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 10, 2023
• Study Start: November 11, 2018
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 4, 2025

Record last verified: 2024-06

Locations

DE (1)