Condition category
Cancer
Date applied
18/04/2017
Date assigned
24/05/2017
Last edited
24/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Bladder cancer is where a tumour develops in the bladder lining. Patients who have high risk early bladder cancer, invasive bladder cancer or locally advanced bladder cancer may have to have their bladder removed (radical cystectomy). In women, sometimes the ovaries may also need to be removed (oophorectomy). There are at present no studies on whether oophorectomy should be performed with radical cystectomy as treatment for muscle-invasive bladder cancer in women. Information is also lacking regarding the effects on hormone levels and sexual function. The aim of this study is to assess the hormone levels and sexual function of women undergoing radical cystectomy with or without oophorectomy for bladder cancer.

Who can participate?
Women aged 18-85 undergoing radical cystectomy for bladder cancer

What does the study involve?
Participants are randomly allocated to undergo radical cystectomy with either no oophorectomy, removal of one ovary or removal of both ovaries. Sexual function and blood hormone levels are assessed at the start of the study and 12 and 52 weeks after the operation.

What are the possible benefits and risks of participating?
Participants allocated to no oophorectomy may benefit from better hormonal, sexual and general function after surgery. There are no risks in participating in this study.

Where is the study run from?
Skåne University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
April 2017 to December 2020

Who is funding the study?
Hillevi Fries Foundation (Sweden)

Who is the main contact?
1. Dr Fredrik Liedberg
2. Dr George Jancke

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
Lund University
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden

Type

Scientific

Additional contact

Dr George Jancke

ORCID ID

Contact details

Department of Urology
Lund University
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-20502
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1/2017

Study information

Scientific title

Impact of oophorectomy at cystectomy for urinary bladder cancer on female hormonal status and sexual function: Randomized study on Oophorectomy at Cystectomy (ROC-study)

Acronym

ROC-study

Study hypothesis

Preservation of ovarian tissue increases sexual function and improves hormonal status after radical cystectomy.

Ethics approval

The Regional Ethical Review Board in Lund, 14/02/2017, ref: 2016/1036 and 2017/2

Study design

Prospective randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Bladder cancer treated with radical cystectomy

Intervention

Patients undergoing radical cystectomy will be randomized using closed envelopes to undergo either:
1. No oophorectomy
2. Excision of one ovary
3. Excision of both ovaries

Oophorectomy will be performed by standard surgical methods, including ligation of parametrium with Ligasure when preserving the one or two ovaries. Follow-up will be 12 months postoperatively according to the protocol, however clinical follow-up will be according to clinical routines.

Intervention type

Phase

Drug names

Primary outcome measures

1. Sexual function, measured using Female Sexual Function Index (FSFI) score at baseline, 12 and 52 weeks postoperatively
2. Hormonal status, measured using plasma levels of total testosterone, dihydrotestosterone, SHBG, anti-müllerian-hormone, androstenedione, dehydroepiandrosterone sulphate, progesterone, oestradiol (sensitive method for postmenopausal women), LH and FSH, at baseline, 12 and 52 weeks postoperatively

Secondary outcome measures

No secondary outcome measures

Overall trial start date

09/04/2017

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women undergoing radical cystectomy
2. Aged 18-85 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

360 female patients

Participant exclusion criteria

1. Clinical suspicion of tumour involvement of either ovaries
2. Previous radiation of the pelvis
3. Previous cystectomy
4. Previous oophorectomy

Recruitment start date

18/04/2017

Recruitment end date

31/12/2020

Locations

Countries of recruitment

Sweden

Trial participating centre

Skåne University Hospital
Department of Urology
Malmö
SE-205 02
Sweden

Sponsor information

Organisation

Lund University

Sponsor details

Dept. of Translational Medicine
Malmö
205 02
Sweden

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Hillevi Fries Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study will be published in a urologic journal after closure.

IPD sharing plan
The datasets generated during and/or analysed during the current study are not expected to be made available due to integrity reasons for the participating patients.

Intention to publish date

31/12/2021

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes