Condition category
Cancer
Date applied
22/03/2016
Date assigned
18/05/2016
Last edited
18/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

Sponsor information

Organisation

Lund University

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes