Sonntag, 28. April 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
PRIME

Prospective Observational Study of a Precision Medicine Approach in Patients With Advanced Cancer

Rekrutierend

NCT-Nummer:
NCT05926284

Studienbeginn:
März 2016

Letztes Update:
03.07.2023

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Charite University, Berlin, Germany

Collaborator:
-

Kontakt

Studienlocations
(1 von 1)

Interdisziplinäres Brustzentrum der Charité im Charité Comprehensive Cancer Center
Virchowweg 23
10117 Berlin
(Berlin)
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Damian T Rieke, MD
Phone: +49 (0)30 450 564 222
E-Mail: cccc@charite.de
» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

Prospective observational study of a precision medicine approach in patients with advanced

cancer. In this registrational study, patients with advanced cancer undergoing extensive

molecular sequencing within the precision oncology program of Charité University Medicine,

Berlin will be registered and followed to assess the efficacy of the program and assess the

clinical relevance and frequency of molecular alterations, individualized therapies and novel

molecular analysis tools.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- advanced cancer

- ability to give written informed consent

- performance status allows initiation of a potential targeted treatment after molecular

analysis

- molecular analysis has been done or planned

Exclusion Criteria:

- unable to give written informed consent

Studien-Rationale

Primary outcome:

1. Frequency of personalized treatment initiation (Time Frame - At 1 year from date of study inclusion):
Frequency of personalized treatment initiation

2. Frequency of molecularly stratified treatment options (Time Frame - At 1 year from date of study inclusion):
Number of molecularly stratified treatment options per patient

Secondary outcome:

1. Progression free survival (Time Frame - Assessed up to 100 months):
From date of study inclusion until the date of first documented progression or date of death from any cause, whichever came first

2. PFS-ratio (Time Frame - Assessed up to 100 months):
Ratio of progression-free survival with molecularly matched therapy to progression-free survival with previous treatment line

3. objective response rate (Time Frame - 1 year after study inclusion):
Best radiographic response as assessed by the investigator

4. frequency of interventional study inclusion (Time Frame - At 1 year after study inclusion):
Number of participants with inclusion in interventional clinical trial

5. frequency of re-diagnosis (Time Frame - At 1 year after study inclusion):
Number of participants with a change in diagnosis a

6. frequency of recommendation of genetic counselling (Time Frame - At 1 year after study inclusion):
Number of participants with a recommendation for genetic counselling

7. frequency of pharmacogenomic findings (Time Frame - At 1 year after study inclusion):
Number of participants with a recommendation for pharmacongenomic considerations a

8. frequency and type of resistance mutations (Time Frame - At 1 year after study inclusion):
Number of molecular alterations predicting resistance to molecularly matched therapy a

9. overall survival (Time Frame - Assessed up to 100 months):
From date of study inclusion until the date of death from any cause, whichever came first

10. Evidence level of molecularly stratified treatment options (Time Frame - At 1 year from study inclusion):
Frequency of evidence levels (according to NCT evidence levels) of molecularly stratified treatment options

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Prospective Observational Study of a Precision Medicine Approach in Patients With Advanced Cancer"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.