Donnerstag, 24. Juni 2021
Navigation öffnen
JOURNAL ONKOLOGIE – STUDIE
PLATON

PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study)

Rekrutierend

NCT-Nummer:
NCT04484636

Studienbeginn:
Oktober 2020

Letztes Update:
02.12.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Pancreatic Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms, Stomach Neoplasms, Liver Neoplasms, Carcinoma, Hepatocellular

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborator:
Roche Pharma AG

Studienleiter

Salah-Eddin Al-Batran, Prof.
Principal Investigator
Institut für Klinische Krebsforschung IKF GmbH
Arndt Vogel, Prof.
Principal Investigator
Hannover Medical School

Kontakt

Studienlocations
(3 von 3)

Studien-Informationen

Detailed Description:

PLATON (Platform for Analyzing Targetable Mutations) is designed to improve personalized

therapy for patients in different cancer entities, such as in hepatocellular cancer (HCC),

intra- and extrahepatic cholangiocellular carcinoma (CCA), gallbladder carcinoma (GBCA),

pancreatic cancer (PanCa) and esophagogastric cancer (EC/GC), and elevate the treatment

guidance within its framework. The key to understand the mechanisms in initiation,

progression and response to treatment of cancer is the data integration of genetic mutational

signatures with medical and physiological data of diseased cohorts.

PLATON is a prospective, multicentre, observational cohort study with biobanking and does not

define any medical intervention or evaluate the efficacy or safety of the treatment decision

made by the investigator.In a first approach PLATON's pilot-study assess genomic profiling in

gastrointestinal cancer therapy and the frequencies of targetable mutations including Tumor

Mutational Burden (TMB) and Microsatellite Instability Status (MSI), performing

Next-generation deep sequencing (NGS) using the Foundation Medicine assays on tumor specimen

and EDTA-whole blood samples. Another important objective of PLATON's pilot project is to

evaluate whether and how many patients are treated based on their genomic profiles.

The pilot-study starts with the national-wide enrolment of 200 participants of both sexes and

ages over 18 at 40 german study sites. The long-term vision is to enable cancer patients to

receive the best available, scientifically founded, biomarker-based care, tailored to his or

her individual needs

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed diagnosis of hepatocellular carcinoma or intra-/extrahepatic

cholangiocarcinoma or gallbladder carcinoma or pancreatic ductal adenocarcinoma or

esophagogastric adenocarcinoma in the advanced setting (adjuvant or neoadjuvant

therapy is allowed if completed 6 months prior to enrolment) and no local curative

therapy available

- Standard first line therapy is planned, or patient is currently receiving first line

therapy (started within the last 2 months before enrolment)

- ECOG 0-2

- Life expectancy ≥ 6 months

Exclusion Criteria:

- Not able to understand all implications of study participation

- No written informed consent

- age < 18 years

Studien-Rationale

Primary outcome:

1. Distribution of mutations in patients with HCC, intra- and extrahepatic CCA, GBCA, PDAC and gastric cancer (Time Frame - up to 4 weeks after biospecimen provision):
Relative frequency of targetable mutations (incl. TMB and MSI status) computed as the number of patients who harbors at least one mutation divided by the number of total patients in the pooled patient population.



Secondary outcome:

1. Heterogeneity of targetable alterations in paraffin embedded specimen vs. cfDNA (Time Frame - up to 4 weeks after biospecimen provision):
Number of differences (heterogeneity) in targetable alterations in paraffin specimen vs. cfDNA

2. Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group (Time Frame - up to 4 weeks after biospecimen provision):
Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group

3. Number of patients receiving therapies in accordance to their genomic profiles (Time Frame - up to 4 weeks after biospecimen provision):
Number of patients receiving therapies in accordance to their genomic profiles

Studien-Arme

  • Other: Hepatocellular Cancer
    molecular profiling - hepatocellular cancer (HCC)
  • Other: Cholangiocarcinoma
    molecular profiling - intra- and extrahepatic cholangiocellular carcinoma (CCA)
  • Other: Gallbladder Cancer
    molecular profiling - gallbladder carcinoma (GBCA)
  • Other: Pancreatic Cancer
    molecular profiling - pancreatic cancer (PanCa)
  • Other: Oesophageal Cancer + Stomach Cancer
    molecular profiling - esophagogastric cancer (EC/GC)

Geprüfte Regime

  • FoundationOne®CDx and FoundationOne®Liquid:
    FoundationOne CDx is a FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information - both to consider appropriate therapies for patients and understand results with evidence of resistance - based on the individual genomic profile of each patient's cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. FoundationOne®Liquid is a liquid biopsy test for solid tumors that analyzes circulating tumor DNA (ctDNA) in blood.

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren
Frühlingssonne genießen – Hautkrebs vermeiden: Deutsche Krebshilfe und ADP einfache Tipps gegen Hautkrebs
Fr%C3%BChlingssonne+genie%C3%9Fen+%E2%80%93+Hautkrebs+vermeiden%3A+Deutsche+Krebshilfe+und+ADP+einfache+Tipps+gegen+Hautkrebs
©Thaut Images - stock.adobe.com

Warmes, sonniges Frühlingswetter: „Balsam für die Seele“ nach entbehrungsreichen Winterwochen im Pandemie-Lockdown. Neben wohltuender Wärme und sichtbarem Licht gehören allerdings auch unsichtbare ultraviolette (UV-) Strahlen zum Spektrum der Sonne. Viele Menschen unterschätzen gerade im Frühjahr die Gefahren der schon jetzt intensiven Sonnenbestrahlung. Die Deutsche Krebshilfe und die...

Die P4-Medizin – Krebstherapie der Zukunft?
Die+P4-Medizin+%E2%80%93+Krebstherapie+der+Zukunft%3F
© Fotolia / psdesign1

Die Versorgung von krebskranken Menschen befindet sich in einem grundlegenden Wandel. Die Entwicklung neuer diagnostischer Methoden und individueller Therapien verändert die onkologische Medizin, wie wir sie bisher kennen. Das jüngst gewonnene Wissen über den Krebs und seine molekularbiologische Vielfalt verlangt nach neuen Antworten. In dem vom amerikanischen Biomediziner Leroy Hood geprägten Konzept der P4-Medizin wird...

EHA 2021
  • SCD: Häufigere und längere VOC-bedingte Krankenhausaufenthalte nach Vorgeschichte von VOC-Hospitalisierungen – Ergebnisse einer Beobachtungsstudie
  • Real-World-Daten des ERNEST-Registers untermauern Überlebensvorteil unter Ruxolitinib bei primärer und sekundärer Myelofibrose
  • I-WISh-Studie: Ärzte sehen TPO-RAs als beste Option, um anhaltende Remissionen bei ITP-Patienten zu erzielen
  • Phase-III-Studie REACH2 bei steroidrefraktärer akuter GvHD: Hohes Ansprechen auf Ruxolitinib auch nach Crossover
  • SCD: Neues digitales Schmerztagebuch zur tagesaktuellen Erfassung von VOCs wird in Beobachtungsstudie geprüft
  • Französische Real-World-Studie: Eltrombopag meist frühzeitig nach ITP-Diagnose im Rahmen eines Off-label-Use eingesetzt
  • Fortgeschrittene systemische Mastozytose: Französische Real-World-Studie bestätigt klinische Studiendaten zur Wirksamkeit von Midostaurin
  • CML-Management weitgehend leitliniengerecht, aber verbesserungsfähig – Ergebnisse einer Querschnittsbefragung bei britischen Hämatologen
  • Britische Real-World-Studie: Kardiovaskuläres Risikomanagement bei MPN-Patienten in der Primärversorgung nicht optimal
  • Myelofibrose: Früher Einsatz von Ruxolitinib unabhängig vom Ausmaß der Knochenmarkfibrose