Plain English Summary
Background and study aims
Survival after chemotherapy for bladder cancer either alone or in combination with surgery is generally limited. Prognostic markers, or biological characteristics, such as levels of a particular protein in the body, that can be used to predict the response of chemotherapy treatment are currently lacking. This study investigates the number of, and characteristics of, circulating
tumour cells (CTCs) in patients with bladder cancer receiving cisplatin-based combination chemotherapy. The aim is to see whether the presence and alterations of CTC-levels during chemotherapy are associated with progression-free survival (that is the time taken from after the treatment to progression of the disease).
Who can participate?
Adults with advanced bladder cancer undergoing chemotherapy.
What does the study involve?
Patients are observed for up to two years during and after their chemotherapy treatment. Blood samples are taken and analysed for CTCs throughout the study.
What are the possible benefits and risks of participating?
The risks of participating in the study is connected with blood sampling only.
Where is the study run from?
Skåne University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
March 2016 to December 2019
Who is funding the study?
Lund University ( Sweden)
Who is the main contact?
Dr Fredrik Liedberg
fredrik.liedberg@skane.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Fredrik Liedberg
ORCID ID
http://orcid.org/0000-0001-8193-0370
Contact details
Department of Urology
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE 205 02
Sweden
+46 40 33 10 00
fredrik.liedberg@skane.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
CIRculating tumour cells in bladder cancer patients treated with CHemotherapy and radical cystectomy – enumeration, characterization and evaluation of prognostic value: a prospective investigational study
Acronym
CIRCH-study
Study hypothesis
Evaluate if presence and alterations of circulating tumour cell (CTC)-levels during chemotherapy are associated with progression-free survival.
Ethics approval
Department 1, Lund University, 21/02/2013, ref: 2013/76
Study design
Prospective investigational
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Urothelial carcinoma
Intervention
Patients are recruited when treatment with chemotherapy either neoadjuvant as induction chemotherapy or in a palliative setting is considered. The levels of circulating tumour cells are monitored for, under and after chemotherapy. The duration of observation includes a minimal of 2 years follow-up after study inclusion.
Intervention type
Drug
Phase
Drug names
Primary outcome measure
Dynamic change in CTC during chemotherapy, using the Cellsearch method
Secondary outcome measures
1. Progression Free Survival (PFS) from date of chemotherapy start to progression/death (via patient chart review, using clinical and radiological (RESIST 1.1) criteria.)
2. Overall Survival (OS), measured as death from any cause
Overall trial start date
09/03/2016
Overall trial end date
30/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Locally advanced high grade urothelial carcinoma of the bladder scheduled for chemotherapy in the following settings; neoadjuvant, induction or palliative
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Bladder cancer with planned chemotherapy as neoadjuvant, induction or palliative intent.
Participant exclusion criteria
Other malignant diseases
Recruitment start date
17/03/2016
Recruitment end date
31/12/2019
Locations
Countries of recruitment
Sweden
Trial participating centre
Skåne University Hospital
Department of Urology
Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden
Funders
Funder type
University/education
Funder name
Lund University ( Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cancerfonden ( Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication of current study will take place at the end of follow-up (2021)
Intention to publish date
31/12/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list