Randomized comparison of oophorectomy or not in conjunction with radical cystectomy in women
ISRCTN | ISRCTN18217210 |
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DOI | https://doi.org/10.1186/ISRCTN18217210 |
Secondary identifying numbers | 1/2017 |
- Submission date
- 18/04/2017
- Registration date
- 24/05/2017
- Last edited
- 24/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
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. This study aims 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 2027
Who is funding the study?
Hillevi Fries Foundation (Sweden)
Who is the main contact?
Prof Fredrik Liedberg
Contact information
Principal Investigator
Dept. of Urology
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden
0000-0001-8193-0370 | |
Phone | +46 40331000 |
fredrik.liedberg@med.lu.se |
Study information
Study design | Prospective randomised study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | No participant information sheet available |
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) |
Study acronym | ROC |
Study objectives | Preservation of ovarian tissue increases sexual function and improves hormonal status after radical cystectomy. |
Ethics approval(s) | The Regional Ethical Review Board in Lund, 14/02/2017, ref: 2016/1036 and 2017/2 |
Health condition(s) or problem(s) studied | 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 | Procedure/Surgery |
Primary outcome measure | 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 study start date | 09/04/2017 |
Completion date | 31/12/2027 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 85 Years |
Sex | Female |
Target number of participants | 360 female patients |
Key inclusion criteria | 1. Women undergoing radical cystectomy 2. Aged 18-85 years |
Key exclusion criteria | 1. Clinical suspicion of tumour involvement of either ovaries 2. Previous radiation of the pelvis 3. Previous cystectomy 4. Previous oophorectomy |
Date of first enrolment | 18/04/2017 |
Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Malmö
SE-205 02
Sweden
Sponsor information
University/education
Dept. of Translational Medicine
Malmö
205 02
Sweden
https://ror.org/012a77v79 |
Funders
Funder type
Charity
No information available
Results and Publications
Intention to publish date | 31/12/2027 |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not expected to be made available |
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. |
Editorial Notes
24/01/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2025 to 31/12/2026.
2. The overall study end date was changed from 31/12/2026 to 31/12/2027.
05/12/2023: The study contacts were updated.
07/11/2023: The contact confirmed the record is up to date.
03/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2021 to 31/12/2025.
2. The overall end date was changed from 31/12/2022 to 31/12/2026.
3. The intention to publish date was changed from 31/12/2021 to 31/12/2027.
4. The plain English summary was updated to reflect these changes.
12/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2020 to 31/12/2021.
2. The overall trial end date was changed from 31/12/2020 to 12/31/2022.