WHENII - Early Response Evaluation With FDG-PET/CT and Liquid Biopsy in Patients With NSCLC
WHENII
1 other identifier
interventional
60
1 country
2
Brief Summary
Response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2018
CompletedFirst Submitted
Initial submission to the registry
March 5, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedOctober 8, 2020
October 1, 2020
3 years
March 5, 2018
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Observation of changes in metabolism in cancer cells during first treatment with chemotherapy or immunotherapy.
Measure changes in standardized uptake value (SUV) in tumorcells by FDG-PET.
3 months
Observation of changes in circulating tumor DNA during first treatment.
Measure changes in the amount of free circulating DNA
3 months
Observation of changes in circulating tumor DNA during first treatment.
Measure changes in cancer DNA by whole genome sequencing on free circulating DNA.
3 months
Study Arms (1)
All patients
OTHERBoth patients receiving chemotherapy and immunotherapy are observed during the same intervention with PET/CT and liquid biopsy. No primary comparison are made between the groups.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with non-small cell lung cancer (NSCLC) who is about to start treatment with chemo- or immune therapy. No prior treatment of the one given.
- Measurable decease according to RECIST criteria
- Age \> 18 years
- Performance status 0-2 (0-1 for immunotherapy)
- Understands and reads danish
You may not qualify if:
- Poor performance status
- Secondary active cancer
- Pregnancy
- Dysregulated diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Copenhagen
Copenhagen, 2200, Denmark
University of Copenhagen
Copenhagen, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andreas Kjær
Klinisk fysiologisk og Nuclearmedicinsk afd
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
March 5, 2018
First Posted
March 29, 2018
Study Start
February 28, 2018
Primary Completion
February 26, 2021
Study Completion
February 28, 2021
Last Updated
October 8, 2020
Record last verified: 2020-10