Circulating tumour cells in bladder cancer patients treated with chemotherapy and radical cystectomy – enumeration, characterization and evaluation of prognostic value (the CIRCH-study)

ISRCTN	ISRCTN72499664
DOI	https://doi.org/10.1186/ISRCTN72499664
Secondary identifying numbers	N/A

Submission date: 22/03/2016
Registration date: 18/05/2016
Last edited: 21/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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@med.lu.se
(updated 21/01/2021, previously: fredrik.liedberg@skane.se)

Contact information

Dr Fredrik Liedberg
Scientific

Department of Urology
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE 205 02
Sweden

ORCID ID	0000-0001-8193-0370
Phone	+46 40 33 10 00
Email	fredrik.liedberg@med.lu.se

Study information

Study design	Prospective investigational
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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
Study acronym	CIRCH-study
Study objectives	Evaluate if presence and alterations of circulating tumour cell (CTC)-levels during chemotherapy are associated with progression-free survival.
Ethics approval(s)	Department 1, Lund University, 21/02/2013, ref: 2013/76
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
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 study start date	09/03/2016
Completion date	30/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Bladder cancer with planned chemotherapy as neoadjuvant, induction or palliative intent.
Key inclusion criteria	Locally advanced high grade urothelial carcinoma of the bladder scheduled for chemotherapy in the following settings; neoadjuvant, induction or palliative
Key exclusion criteria	Other malignant diseases
Date of first enrolment	17/03/2016
Date of final enrolment	31/12/2019

Locations

Countries of recruitment

Sweden

Study participating centre

Skåne University Hospital

Department of Urology
Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden

Sponsor information

Lund University
University/education

Institute Translational Medicine
Jan Waldenströms gata 35
Malmö
SE-205 02
Sweden

"ROR"	https://ror.org/012a77v79

Funders

Funder type

University/education

Lund University ( Sweden)

No information available

Cancerfonden ( Sweden)

No information available

Results and Publications

Intention to publish date	31/12/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Publication of current study will take place at the end of follow-up (2021)
IPD sharing plan

Editorial Notes

21/01/2021: The contact email was updated.