NCT05926284

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
58mo left

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Mar 2016Mar 2031

Study Start

First participant enrolled

March 1, 2016

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

14 years

First QC Date

April 8, 2023

Last Update Submit

June 21, 2023

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

  • Frequency of personalized treatment initiation

    Frequency of personalized treatment initiation

    At 1 year from date of study inclusion

  • Frequency of molecularly stratified treatment options

    Number of molecularly stratified treatment options per patient

    At 1 year from date of study inclusion

Secondary Outcomes (10)

  • Progression free survival

    Assessed up to 100 months

  • PFS-ratio

    Assessed up to 100 months

  • objective response rate

    1 year after study inclusion

  • frequency of interventional study inclusion

    At 1 year after study inclusion

  • frequency of re-diagnosis

    At 1 year after study inclusion

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced cancer presenting to the precision oncology program at Charité for molecular analyses to identify personalized treatment options.

You may qualify if:

  • 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

You may not qualify if:

  • \- unable to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Comprehensive Cancer Center

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Damian T Rieke, MD

CONTACT

+49 (0)30 450 564 222cccc@charite.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Speaker, Platform for personalized cancer therapy at Charité Comprehensive Cancer Center, Principal Investigator, Medical Doctor

Study Record Dates

First Submitted

April 8, 2023

First Posted

July 3, 2023

Study Start

March 1, 2016

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2031

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations

DE(1)